Trial Outcomes & Findings for Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010) (NCT NCT01905657)
NCT ID: NCT01905657
Last Updated: 2021-10-06
Results Overview
OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 September (Sep) 2015.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
1034 participants
Primary outcome timeframe
Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)
Results posted on
2021-10-06
Participant Flow
Participants who had non-small cell lung cancer (NSCLC) and whose tumors were assessed as being programmed cell death ligand 1 (PD-L1) positive were recruited for this study.
Per protocol, response or progression during the second and switch over pembrolizumab courses was not counted towards efficacy outcome measures, and adverse events during the second and switch over pembrolizumab courses were not counted towards safety outcome measures. Final analyses for all primary and secondary outcome measures was done at the protocol-specified cutoff of 30-Sep-2015.
Participant milestones
| Measure |
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
|---|---|---|---|
|
Overall Study
STARTED
|
345
|
346
|
343
|
|
Overall Study
Treated
|
339
|
343
|
309
|
|
Overall Study
Received Second Course of Pembrolizumab
|
14
|
7
|
0
|
|
Overall Study
Switched Over to Pembrolizumab
|
0
|
0
|
8
|
|
Overall Study
COMPLETED
|
142
|
159
|
143
|
|
Overall Study
NOT COMPLETED
|
203
|
187
|
200
|
Reasons for withdrawal
| Measure |
Pembrolizumab 2 mg/kg
Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
23
|
17
|
18
|
|
Overall Study
Clinical Progression
|
103
|
78
|
59
|
|
Overall Study
Death
|
40
|
43
|
47
|
|
Overall Study
Excluded Medication
|
13
|
16
|
9
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
|
Overall Study
Physician Decision
|
5
|
8
|
12
|
|
Overall Study
Protocol Violation
|
2
|
1
|
1
|
|
Overall Study
Screen Failure
|
0
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
15
|
21
|
53
|
|
Overall Study
Sponsor Decision
|
1
|
0
|
0
|
Baseline Characteristics
Study of Two Doses of Pembrolizumab (MK-3475) Versus Docetaxel in Previously Treated Participants With Non-Small Cell Lung Cancer (MK-3475-010/KEYNOTE-010)
Baseline characteristics by cohort
| Measure |
Pembrolizumab 2 mg/kg
n=345 Participants
Participants received pembrolizumab 2 mg/kg intravenously (IV) over 30 minutes every 3 weeks (Q3W) for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg
n=346 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2
n=343 Participants
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
Total
n=1034 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.1 Years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
62.3 Years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
61.6 Years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
62.0 Years
STANDARD_DEVIATION 9.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
132 Participants
n=5 Participants
|
133 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
399 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
213 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
209 Participants
n=5 Participants
|
635 Participants
n=4 Participants
|
|
PD-L1 Tumor Expression Status
Weakly PD-L1 Positive
|
206 Participants
n=5 Participants
|
195 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
592 Participants
n=4 Participants
|
|
PD-L1 Tumor Expression Status
Strongly PD-L1 Positive
|
139 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
152 Participants
n=5 Participants
|
442 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)Population: Per protocol, OS for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive OS data available and usable. Participants were included in the treatment group to which they were randomized.
OS was defined as the time from randomization to death due to any cause. OS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 September (Sep) 2015.
Outcome measures
| Measure |
Pembrolizumab 2 mg/kg
n=344 Participants
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg
n=346 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2
n=343 Participants
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
|---|---|---|---|
|
Overall Survival (OS)
Strongly PD-L1 Positive
|
14.9 Months
Interval 10.4 to
Upper limit of OS not reached, due to insufficient number of deaths in the study.
|
17.3 Months
Interval 11.8 to
Upper limit of OS not reached, due to insufficient number of deaths in the study.
|
8.2 Months
Interval 6.4 to 10.7
|
|
Overall Survival (OS)
All PD-L1 Positive
|
10.4 Months
Interval 9.4 to 11.9
|
12.7 Months
Interval 10.0 to 17.3
|
8.5 Months
Interval 7.5 to 9.8
|
PRIMARY outcome
Timeframe: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)Population: Per protocol, PFS for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive PFS data available and usable. Participants were included in the treatment group to which they were randomized.
PFS was defined as the time from the first day of study treatment to the first documented disease progression per RECIST 1.1 based on blinded independent central radiologists' review or death due to any cause, whichever occurred first. Using RECIST 1.1, progressive disease was defined as either a 20% relative increase in the sum of diameters of target lesions, taking as reference the smallest sum on study OR an absolute increase of \>5 mm in the sum of lesions, OR the appearance of new lesions. PFS was analyzed using the Kaplan-Meier method and is reported in months. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Outcome measures
| Measure |
Pembrolizumab 2 mg/kg
n=344 Participants
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg
n=346 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2
n=343 Participants
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
|---|---|---|---|
|
Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Strongly PD-L1 Positive
|
5.2 Months
Interval 4.0 to 6.5
|
5.2 Months
Interval 4.1 to 8.1
|
4.1 Months
Interval 3.6 to 4.3
|
|
Progression-free Survival (PFS) by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
All PD-L1 Positive
|
3.9 Months
Interval 3.1 to 4.1
|
4.0 Months
Interval 2.6 to 4.3
|
4.0 Months
Interval 3.1 to 4.2
|
PRIMARY outcome
Timeframe: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)Population: Per protocol, participants experiencing AEs for the first pembrolizumab course and docetaxel treatment arms were analyzed in the All Participants As Treated (APAT) population. This consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Outcome measures
| Measure |
Pembrolizumab 2 mg/kg
n=339 Participants
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg
n=343 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2
n=309 Participants
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
|---|---|---|---|
|
Percentage of Participants Experiencing Adverse Events (AEs)
|
97.6 Percentage of Participants
|
96.2 Percentage of Participants
|
96.1 Percentage of Participants
|
PRIMARY outcome
Timeframe: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)Population: Per protocol, participants discontinuing study treatment due to AEs, for the first pembrolizumab course and docetaxel treatment arms were analyzed in the APAT population. This consisted of all participants who received at least one dose of study drug. Participants were included in the treatment group based on the study treatment they received.
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have a causal relationship with this treatment. An AE is any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a pre-existing condition that was temporally associated with the use of the study drug, was also an AE. Per protocol, final analysis for this primary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Outcome measures
| Measure |
Pembrolizumab 2 mg/kg
n=339 Participants
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg
n=343 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2
n=309 Participants
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
|---|---|---|---|
|
Percentage of Participants Discontinuing Study Drug Due to AEs
|
8.3 Percentage of Participants
|
7.6 Percentage of Participants
|
13.6 Percentage of Participants
|
SECONDARY outcome
Timeframe: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)Population: Per protocol, ORR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who had strongly PD-L1 positive and all PD-L1 positive ORR data available and usable. Participants were included in the treatment group to which they were randomized.
ORR was defined as the percentage of participants in the analysis population who had a Complete Response (CR; disappearance of all target lesions) or Partial Response (PR; at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters) based on blinded independent central radiologists' review using RECIST 1.1. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Outcome measures
| Measure |
Pembrolizumab 2 mg/kg
n=344 Participants
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg
n=346 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2
n=343 Participants
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
|---|---|---|---|
|
Overall Response Rate (ORR) by RECIST 1.1
Strongly PD-L1 Positive
|
30.2 Percentage of Participants
Interval 22.7 to 38.6
|
29.1 Percentage of Participants
Interval 22.0 to 37.1
|
7.9 Percentage of Participants
Interval 4.1 to 13.4
|
|
Overall Response Rate (ORR) by RECIST 1.1
All PD-L1 Positive
|
18.0 Percentage of Participants
Interval 14.1 to 22.5
|
18.5 Percentage of Participants
Interval 14.5 to 23.0
|
9.3 Percentage of Participants
Interval 6.5 to 12.9
|
SECONDARY outcome
Timeframe: Through pre-specified database cutoff date of 30 Sep 2015 (Up to approximately 24 months)Population: Per protocol, DOR for the first pembrolizumab course and docetaxel treatment arms was analyzed in all randomized participants who demonstrated a CR/PR and had strongly PD-L1 positive and all PD-L1 positive DOR data available and usable. Participants were included in the treatment group to which they were randomized.
DOR is measured from the time measurement criteria were first met for CR/PR (whichever was first recorded) until the first date that death or progressive disease was objectively documented (taking as reference for progressive disease the smallest measurements recorded on study). Non-responders were not included in the analysis. DOR was analyzed using the Kaplan-Meier method and is reported in weeks. Per protocol, final analysis for this secondary outcome measure was performed for the first pembrolizumab course and docetaxel treatment arms, with a protocol-specified analysis data cutoff date of 30 Sep 2015.
Outcome measures
| Measure |
Pembrolizumab 2 mg/kg
n=62 Participants
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg
n=64 Participants
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years. Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2
n=32 Participants
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years. Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
|---|---|---|---|
|
Duration of Response (DOR) by RECIST 1.1
All PD-L1 Positive
|
NA Weeks
Interval 3.0 to
Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
|
NA Weeks
Interval 9.0 to
Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
|
27 Weeks
Interval 6.0 to
DOR upper limit not reached: No progressive disease by the time of last disease assessment.
|
|
Duration of Response (DOR) by RECIST 1.1
Strongly PD-L1 Positive
|
NA Weeks
Interval 3.0 to
Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
|
NA Weeks
Interval 9.0 to
Median DOR and DOR upper limit not reached: No progressive disease by the time of last disease assessment.
|
35 Weeks
Interval 9.0 to
DOR upper limit not reached: No progressive disease by the time of last disease assessment.
|
Adverse Events
Pembrolizumab 2 mg/kg First Course
Serious events: 124 serious events
Other events: 312 other events
Deaths: 294 deaths
Pembrolizumab 10 mg/kg First Course
Serious events: 133 serious events
Other events: 301 other events
Deaths: 289 deaths
Docetaxel 75 mg/m^2
Serious events: 107 serious events
Other events: 279 other events
Deaths: 303 deaths
Pembrolizumab 2 mg/kg First Course to Pembrolizumab 200 mg Second Course
Serious events: 5 serious events
Other events: 9 other events
Deaths: 4 deaths
Pembrolizumab 10 mg/kg First Course to Pembrolizumab 200 mg Second Course
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
Docetaxel 75 mg/m^2 Switched Over to Pembrolizumab 200 mg
Serious events: 1 serious events
Other events: 7 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Pembrolizumab 2 mg/kg First Course
n=339 participants at risk
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
|
Pembrolizumab 10 mg/kg First Course
n=343 participants at risk
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
|
Docetaxel 75 mg/m^2
n=309 participants at risk
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years.
|
Pembrolizumab 2 mg/kg First Course to Pembrolizumab 200 mg Second Course
n=14 participants at risk
Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg First Course to Pembrolizumab 200 mg Second Course
n=7 participants at risk
Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2 Switched Over to Pembrolizumab 200 mg
n=8 participants at risk
Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.2%
4/343 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.6%
11/309 • Number of events 11 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.6%
5/309 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Normocytic anaemia
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.88%
3/339 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrial flutter
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrial thrombosis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac failure
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiomyopathy
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Myocardial infarction
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Pericardial effusion
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Pericarditis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Restrictive cardiomyopathy
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Cardiac disorders
Ventricular fibrillation
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Congenital, familial and genetic disorders
Pyloric stenosis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Congenital, familial and genetic disorders
Tracheo-oesophageal fistula
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Endocrine disorders
Adrenal suppression
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypopituitarism
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.59%
2/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Autoimmune pancreatitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Faecaloma
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Intra-abdominal haemorrhage
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal hypomotility
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal obstruction
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Axillary pain
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Chest pain
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Death
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.87%
3/343 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
General physical health deterioration
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Malaise
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Oedema
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Pain
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.2%
4/343 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.3%
4/309 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatocellular injury
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Immune system disorders
Drug hypersensitivity
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Bronchitis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Device related sepsis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
External ear cellulitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Gastroenteritis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Gastrointestinal infection
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Infectious pleural effusion
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Influenza
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Large intestine infection
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Mucosal infection
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Phlebitis infective
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Pleural infection
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
5.9%
20/339 • Number of events 22 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
6.1%
21/343 • Number of events 22 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
6.1%
19/309 • Number of events 22 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia bacterial
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia haemophilus
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Pyopneumothorax
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection
|
1.2%
4/339 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.87%
3/343 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Sepsis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Septic shock
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Staphylococcal infection
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Vascular device infection
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Incisional hernia, obstructive
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Radiation pneumonitis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Thoracic vertebral fracture
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Blood bilirubin increased
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
C-reactive protein increased
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Platelet count decreased
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.3%
4/309 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.5%
5/343 • Number of events 7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Muscle necrosis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.29%
1/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Ischaemic stroke
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Osteoporotic fracture
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
0.29%
1/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Paraneoplastic syndrome
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Brain oedema
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Hemiparesis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Myelitis transverse
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Syncope
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Toxic leukoencephalopathy
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Product Issues
Device dislocation
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Psychiatric disorders
Anxiety
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Psychiatric disorders
Confusional state
|
0.88%
3/339 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Bladder hypertrophy
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Haematuria
|
0.29%
1/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Urinary bladder polyp
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Urinary retention
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial haemorrhage
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.8%
6/339 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.8%
6/339 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.9%
6/309 • Number of events 7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.2%
4/343 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.1%
14/339 • Number of events 15 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.9%
10/343 • Number of events 10 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.4%
8/339 • Number of events 8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.3%
8/343 • Number of events 8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.6%
5/309 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
2/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary vascular disorder
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Hypotension
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Peripheral artery occlusion
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Superior vena cava occlusion
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Superior vena cava syndrome
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Infective spondylitis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Otitis externa
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab 2 mg/kg First Course
n=339 participants at risk
Participants received pembrolizumab 2 mg/kg IV over 30 minutes Q3W for up to 2 years.
|
Pembrolizumab 10 mg/kg First Course
n=343 participants at risk
Participants received pembrolizumab 10 mg/kg IV over 30 minutes Q3W for up to 2 years.
|
Docetaxel 75 mg/m^2
n=309 participants at risk
Participants received docetaxel 75 mg/m\^2 IV over 1 hour Q3W for up to 2 years.
|
Pembrolizumab 2 mg/kg First Course to Pembrolizumab 200 mg Second Course
n=14 participants at risk
Qualified participants who received the first course of pembrolizumab 2 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Pembrolizumab 10 mg/kg First Course to Pembrolizumab 200 mg Second Course
n=7 participants at risk
Qualified participants who received the first course of pembrolizumab 10 mg/kg Q3W for up to 2 years, but experienced disease progression, initiated a second course of pembrolizumab at the investigator's discretion, at 200 mg IV Q3W for up to 1 year.
|
Docetaxel 75 mg/m^2 Switched Over to Pembrolizumab 200 mg
n=8 participants at risk
Qualified participants who received docetaxel 75 mg/m\^2 Q3W for up to 2 years, but experienced disease progression, switched over to pembrolizumab, at the investigator's discretion, at 200 mg IV Q3W for up to 2 years.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
10.9%
37/339 • Number of events 50 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
9.3%
32/343 • Number of events 43 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
19.7%
61/309 • Number of events 71 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
2/14 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
15.2%
47/309 • Number of events 103 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
3.5%
12/339 • Number of events 13 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
5.5%
19/343 • Number of events 19 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
2/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
8.6%
29/339 • Number of events 30 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
8.5%
29/343 • Number of events 34 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Eye disorders
Lacrimation increased
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
5.5%
17/309 • Number of events 18 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.9%
20/339 • Number of events 24 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
6.1%
21/343 • Number of events 23 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
4.2%
13/309 • Number of events 17 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
2/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
17.4%
59/339 • Number of events 65 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
16.6%
57/343 • Number of events 64 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
13.3%
41/309 • Number of events 47 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
18.3%
62/339 • Number of events 91 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.9%
51/343 • Number of events 62 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
26.2%
81/309 • Number of events 111 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
25.0%
2/8 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
25.7%
87/339 • Number of events 105 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
21.9%
75/343 • Number of events 92 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
21.0%
65/309 • Number of events 80 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Stomatitis
|
5.6%
19/339 • Number of events 22 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.8%
13/343 • Number of events 15 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
15.9%
49/309 • Number of events 72 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
15.0%
51/339 • Number of events 60 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.0%
48/343 • Number of events 59 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
10.4%
32/309 • Number of events 37 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
13.0%
44/339 • Number of events 60 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
13.1%
45/343 • Number of events 59 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
16.5%
51/309 • Number of events 72 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Chest pain
|
7.4%
25/339 • Number of events 26 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
9.3%
32/343 • Number of events 40 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
22/309 • Number of events 23 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
30.1%
102/339 • Number of events 122 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
25.7%
88/343 • Number of events 107 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
34.3%
106/309 • Number of events 131 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Oedema peripheral
|
8.8%
30/339 • Number of events 35 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
8.2%
28/343 • Number of events 30 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
11.0%
34/309 • Number of events 37 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
15.0%
51/339 • Number of events 68 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
11.7%
40/343 • Number of events 64 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
13.6%
42/309 • Number of events 56 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
2/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
20/339 • Number of events 26 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
6.7%
23/343 • Number of events 29 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
5.2%
16/309 • Number of events 16 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.3%
18/339 • Number of events 19 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
5.2%
18/343 • Number of events 26 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.6%
11/309 • Number of events 12 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
28.6%
2/7 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
19/339 • Number of events 21 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.9%
10/343 • Number of events 12 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.9%
9/309 • Number of events 10 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
7.7%
26/339 • Number of events 35 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
5.8%
20/343 • Number of events 22 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.6%
5/309 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
5.9%
20/339 • Number of events 29 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
6.1%
21/343 • Number of events 24 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.3%
4/309 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.5%
12/339 • Number of events 16 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
5.5%
19/343 • Number of events 19 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.6%
5/309 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Blood creatinine increased
|
5.6%
19/339 • Number of events 26 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
5.0%
17/343 • Number of events 20 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.3%
4/309 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Neutrophil count decreased
|
0.88%
3/339 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.87%
3/343 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
8.1%
25/309 • Number of events 45 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
9.4%
32/339 • Number of events 37 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
9.6%
33/343 • Number of events 34 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.6%
11/309 • Number of events 13 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.87%
3/343 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
5.5%
17/309 • Number of events 29 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.7%
104/339 • Number of events 123 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
23.3%
80/343 • Number of events 93 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
23.9%
74/309 • Number of events 87 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
28.6%
2/7 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
50.0%
4/8 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
18/339 • Number of events 27 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
4.4%
15/343 • Number of events 27 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.9%
12/309 • Number of events 13 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.2%
48/339 • Number of events 67 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.2%
42/343 • Number of events 50 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
9.4%
29/309 • Number of events 34 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
28.6%
2/7 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.1%
41/339 • Number of events 48 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
13.1%
45/343 • Number of events 51 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.4%
23/309 • Number of events 25 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
11.5%
39/339 • Number of events 48 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
10.8%
37/343 • Number of events 41 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.2%
10/309 • Number of events 16 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
20/339 • Number of events 28 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
4.4%
15/343 • Number of events 18 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
11.3%
35/309 • Number of events 52 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.5%
22/339 • Number of events 23 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.6%
26/343 • Number of events 27 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
4.2%
13/309 • Number of events 16 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
8.8%
30/339 • Number of events 37 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.0%
24/343 • Number of events 26 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.9%
12/309 • Number of events 15 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Dysgeusia
|
1.5%
5/339 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.3%
8/343 • Number of events 8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
6.1%
19/309 • Number of events 24 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Headache
|
12.4%
42/339 • Number of events 47 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
10.2%
35/343 • Number of events 43 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
22/309 • Number of events 25 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Neuropathy peripheral
|
2.4%
8/339 • Number of events 9 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.6%
9/343 • Number of events 9 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.0%
37/309 • Number of events 39 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Paraesthesia
|
2.1%
7/339 • Number of events 9 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.3%
8/343 • Number of events 9 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
6.5%
20/309 • Number of events 22 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.5%
5/339 • Number of events 7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.7%
6/343 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
5.5%
17/309 • Number of events 17 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Psychiatric disorders
Anxiety
|
5.3%
18/339 • Number of events 19 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
4.7%
16/343 • Number of events 16 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.9%
9/309 • Number of events 9 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Psychiatric disorders
Insomnia
|
8.0%
27/339 • Number of events 29 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
6.4%
22/343 • Number of events 22 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
22/309 • Number of events 24 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.2%
82/339 • Number of events 104 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
21.9%
75/343 • Number of events 94 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
13.9%
43/309 • Number of events 47 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
2/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
23.9%
81/339 • Number of events 92 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
23.0%
79/343 • Number of events 95 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
21.0%
65/309 • Number of events 71 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
2/14 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.7%
26/339 • Number of events 37 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.6%
26/343 • Number of events 33 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
6.5%
20/309 • Number of events 29 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.2%
21/339 • Number of events 30 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
8.7%
30/343 • Number of events 32 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.2%
10/309 • Number of events 12 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.8%
6/339 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.5%
5/343 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
35.6%
110/309 • Number of events 112 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.4%
15/339 • Number of events 19 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
5.5%
19/343 • Number of events 25 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.6%
8/309 • Number of events 8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
13.3%
45/339 • Number of events 62 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
15.2%
52/343 • Number of events 76 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.6%
11/309 • Number of events 11 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
28.6%
4/14 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.2%
48/339 • Number of events 62 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
17.2%
59/343 • Number of events 78 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
22/309 • Number of events 22 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
16.7%
1/6 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
4/339 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.7%
6/343 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.3%
7/309 • Number of events 7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Eye disorders
Conjunctival haemorrhage
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.2%
11/339 • Number of events 11 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.5%
12/343 • Number of events 13 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.3%
7/309 • Number of events 7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dyspepsia
|
2.9%
10/339 • Number of events 13 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.5%
5/343 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
4.5%
14/309 • Number of events 14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oral pain
|
0.59%
2/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.9%
6/309 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Gait disturbance
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.3%
4/309 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Influenza like illness
|
2.7%
9/339 • Number of events 15 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.5%
12/343 • Number of events 16 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Infusion site extravasation
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.3%
4/309 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
General disorders
Oedema
|
2.1%
7/339 • Number of events 9 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.87%
3/343 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.9%
6/309 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Cystitis
|
1.5%
5/339 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Fungal infection
|
0.88%
3/339 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Influenza
|
2.4%
8/339 • Number of events 8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.87%
3/343 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Paraspinal abscess
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection
|
4.1%
14/339 • Number of events 16 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.0%
7/343 • Number of events 12 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.9%
9/309 • Number of events 10 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Contusion
|
1.2%
4/339 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.5%
5/343 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Fall
|
1.2%
4/339 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.87%
3/343 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Amylase increased
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
1.5%
5/339 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.2%
4/343 • Number of events 6 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
4.4%
15/339 • Number of events 20 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.5%
5/343 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Investigations
Serum ferritin decreased
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Folate deficiency
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
1.8%
6/339 • Number of events 7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.0%
7/343 • Number of events 8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.9%
10/339 • Number of events 14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.9%
10/343 • Number of events 15 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.97%
3/309 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.4%
15/339 • Number of events 18 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.3%
8/343 • Number of events 16 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.6%
11/309 • Number of events 12 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Balance disorder
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.3%
4/309 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Facial paralysis
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Sciatica
|
1.2%
4/339 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Nervous system disorders
Amnesia
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Psychiatric disorders
Depressed mood
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.87%
3/343 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal failure
|
1.2%
4/339 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.88%
3/339 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.3%
8/343 • Number of events 8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.8%
13/339 • Number of events 14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.3%
8/343 • Number of events 9 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.9%
9/309 • Number of events 9 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.7%
9/339 • Number of events 11 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.5%
12/343 • Number of events 12 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.3%
7/309 • Number of events 7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.4%
8/339 • Number of events 9 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.0%
7/343 • Number of events 8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.88%
3/339 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
2.0%
7/343 • Number of events 7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.6%
5/309 • Number of events 5 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Macule
|
0.00%
0/339 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.58%
2/343 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/309 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/343 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
1.2%
4/339 • Number of events 4 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.87%
3/343 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Embolism
|
0.59%
2/339 • Number of events 2 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.32%
1/309 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
7.1%
1/14 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
4.4%
15/339 • Number of events 16 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
3.5%
12/343 • Number of events 12 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
1.9%
6/309 • Number of events 7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/7 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
12.5%
1/8 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
|
Vascular disorders
Orthostatic hypotension
|
0.29%
1/339 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.29%
1/343 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.65%
2/309 • Number of events 3 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/14 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
14.3%
1/7 • Number of events 1 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
0.00%
0/8 • Safety: Up to ~35 months for pembrolizumab first course and up to additional ~27 months for pembrolizumab second and switch over courses; All-cause mortality (ACM): Up to ~83 months for pembrolizumab first, second and switch over courses
Safety and ACM were analyzed by treatment (pembrolizumab 2 mg/kg, 10 mg/kg, docetaxel 75 mg/m\^2) and course (first, second, switch over). ACM was analyzed in all randomized participants and safety in all participants who got ≥1 dose of study drug. Per protocol disease progression of cancer was not considered an AE unless related to study drug. Thus, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression", "Disease progression" unrelated to study drug are excluded as AEs.
|
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 study 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.
- Publication restrictions are in place
Restriction type: OTHER