Trial Outcomes & Findings for Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors (NCT NCT04696055)
NCT ID: NCT04696055
Last Updated: 2025-05-13
Results Overview
Overall response rate (ORR) is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR). ORR per RECIST 1.1 by independent central assessment is reported). RECIST 1.1: response evaluation criteria in solid tumors version 1.1
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
95 participants
Primary outcome timeframe
Up to 15 months. Data up to 38 months are now available and are also reported for full transparency.
Results posted on
2025-05-13
Participant Flow
The study was conducted between 03 February 2021 (first participant first visit) and 23 April 2024 (last participant last visit) at 39 centers in 8 countries.
A total of 136 participants were screened, of whom 41 were screening failures. A total of 95 participants were assigned to treatment.
Participant milestones
| Measure |
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab])
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only.
Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment])
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens.
Pembrolizumab 400 mg was administered as an IV infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
|---|---|---|
|
Overall Study
STARTED
|
68
|
27
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
68
|
27
|
Reasons for withdrawal
| Measure |
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab])
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only.
Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment])
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens.
Pembrolizumab 400 mg was administered as an IV infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
2
|
|
Overall Study
Death
|
4
|
0
|
|
Overall Study
Other
|
7
|
2
|
|
Overall Study
Physician Decision
|
3
|
0
|
|
Overall Study
Progressive Disease - Clinical Progression
|
1
|
1
|
|
Overall Study
Progressive Disease - Radiological Progression
|
42
|
20
|
|
Overall Study
Subject Decision
|
1
|
2
|
Baseline Characteristics
Regorafenib Plus Pembrolizumab in Patients With Advanced or Spreading Liver Cancer Who Have Been Previously Treated With PD-1/PD-L1 Immune Checkpoint Inhibitors
Baseline characteristics by cohort
| Measure |
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab])
n=68 Participants
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only.
Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment])
n=27 Participants
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens.
Pembrolizumab 400 mg was administered as an IV infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61.7 Years
STANDARD_DEVIATION 13.1 • n=99 Participants
|
70.9 Years
STANDARD_DEVIATION 7.3 • n=107 Participants
|
64.3 Years
STANDARD_DEVIATION 12.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
53 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
18 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Up to 15 months. Data up to 38 months are now available and are also reported for full transparency.Population: Full Analysis Set (FAS)
Overall response rate (ORR) is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR). ORR per RECIST 1.1 by independent central assessment is reported). RECIST 1.1: response evaluation criteria in solid tumors version 1.1
Outcome measures
| Measure |
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab])
n=68 Participants
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only.
Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment])
n=27 Participants
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens.
Pembrolizumab 400 mg was administered as an IV infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
|---|---|---|
|
Overall Response Rate (ORR) Per RECIST 1.1 by Central Assessment
Up to 15 months (primary outcome as previously reported)
|
5.9 Percentage of participants
Interval 1.6 to 14.4
|
11.1 Percentage of participants
Interval 2.4 to 29.2
|
|
Overall Response Rate (ORR) Per RECIST 1.1 by Central Assessment
Up to 38 months (as of study completion)
|
7.4 Percentage of participants
Interval 2.4 to 16.3
|
14.8 Percentage of participants
Interval 4.2 to 33.7
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: Full Analysis Set (FAS)
Overall response rate (ORR) is defined as the percentage of participants with best overall response of confirmed complete response (CR) or partial response (PR). ORR by RECIST 1.1 investigator review is reported. RECIST 1.1: response evaluation criteria in solid tumors version 1.1
Outcome measures
| Measure |
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab])
n=68 Participants
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only.
Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment])
n=27 Participants
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens.
Pembrolizumab 400 mg was administered as an IV infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
|---|---|---|
|
Overall Response Rate (ORR) Per RECIST 1.1 by Investigator Assessment
|
7.4 Percentage of participants
Interval 2.4 to 16.3
|
18.5 Percentage of participants
Interval 6.3 to 38.1
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: Confirmed responders in Full Analysis Set (FAS)
Duration of response (DOR) for partial response (PR) and complete response (CR) was defined as the time from the first documented objective response of PR or CR, whichever noted earlier, to disease progression or death (if death occurs before progression was documented). DOR was defined for confirmed responders only, i.e., participants with a CR or PR. RECIST 1.1: response evaluation criteria in solid tumors version 1.1
Outcome measures
| Measure |
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab])
n=5 Participants
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only.
Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment])
n=5 Participants
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens.
Pembrolizumab 400 mg was administered as an IV infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
|---|---|---|
|
Duration of Response (DOR) Per RECIST 1.1 by Central Assessment and Investigator Assessment
Central assessment
|
210 Days
Interval 158.0 to 937.0
|
195 Days
Interval 83.0 to 280.0
|
|
Duration of Response (DOR) Per RECIST 1.1 by Central Assessment and Investigator Assessment
Investigator assessment
|
431 Days
Interval 82.0 to 893.0
|
364 Days
Interval 117.0 to 839.0
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: Full Analysis Set (FAS)
An AE was considered as treatment-emergent (TEAE) if arising or worsening after start of first study intervention administration until 30 days after administration of any study intervention. In addition, any AEs qualifying as a serious adverse event (SAE) were collected for 90 days after the last dose of pembrolizumab, unless a new anti-cancer therapy had been initiated.
Outcome measures
| Measure |
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab])
n=68 Participants
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only.
Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment])
n=27 Participants
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens.
Pembrolizumab 400 mg was administered as an IV infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any TEAE
|
68 Participants
|
27 Participants
|
|
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Any SAE
|
37 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Up to 38 monthsNumber of participants with clinically relevant trends observed in laboratory data, ECG data, or ECOG performance status is reported.
Outcome measures
| Measure |
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab])
n=68 Participants
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only.
Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment])
n=27 Participants
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens.
Pembrolizumab 400 mg was administered as an IV infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
|---|---|---|
|
Number of Participants With Safety-relevant Changes in Clinical Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 38 monthsPopulation: Full Analysis Set (FAS)
Dose modification included dose interruption, dose reduction, dose discontinuation.
Outcome measures
| Measure |
Cohort 1 (Regorafenib + Pembrolizumab [1L: Atezolizumab + Bevacizumab])
n=68 Participants
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only.
Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Cohort 2 (Regorafenib + Pembrolizumab [1L: Any Other IO Containing Treatment])
n=27 Participants
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens.
Pembrolizumab 400 mg was administered as an IV infusion every 6 weeks. Regorafenib was given orally at a starting dose of 90 mg once daily for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
|---|---|---|
|
Percentage of Participants With Dose Modification
Regorafenib - drug interruptions or delays
|
63.2 Percentage of participants
|
70.4 Percentage of participants
|
|
Percentage of Participants With Dose Modification
Regorafenib - dose reductions
|
41.2 Percentage of participants
|
63.0 Percentage of participants
|
|
Percentage of Participants With Dose Modification
Regorafenib - drug withdrawal
|
16.2 Percentage of participants
|
25.9 Percentage of participants
|
|
Percentage of Participants With Dose Modification
Pembrolizumab - dose interruptions or delays
|
14.7 Percentage of participants
|
25.9 Percentage of participants
|
|
Percentage of Participants With Dose Modification
Pembrolizumab - drug withdrawal
|
4.4 Percentage of participants
|
11.1 Percentage of participants
|
Adverse Events
Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab]
Serious events: 37 serious events
Other events: 63 other events
Deaths: 53 deaths
Regorafenib+Pembrolizumab [Any Other IO Containing Treatment]
Serious events: 11 serious events
Other events: 27 other events
Deaths: 20 deaths
Serious adverse events
| Measure |
Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab]
n=68 participants at risk
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only. Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks (Q6W). Regorafenib was given orally (p.o.) at a starting dose of 90 mg once daily (QD) for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Regorafenib+Pembrolizumab [Any Other IO Containing Treatment]
n=27 participants at risk
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens. Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks (Q6W). Regorafenib was given orally (p.o.) at a starting dose of 90 mg once daily (QD) for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.9%
2/68 • Number of events 5 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Cardiac disorders
Atrial fibrillation
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Cardiac disorders
Cardiac arrest
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Ascites
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
Pyrexia
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Gastric ulcer perforation
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Gastritis erosive
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Haematochezia
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Haemoperitoneum
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Melaena
|
2.9%
2/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Oesophageal varices haemorrhage
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
Asthenia
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
Death
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
Fatigue
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
Injection site haematoma
|
1.5%
1/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
General physical health deterioration
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
Systemic inflammatory response syndrome
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.5%
1/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Hepatobiliary disorders
Hepatitis
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Hepatobiliary disorders
Hepatic cytolysis
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Hepatobiliary disorders
Biliary obstruction
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Infections and infestations
Bronchitis
|
1.5%
1/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Infections and infestations
Pneumonia
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Infections and infestations
Sepsis
|
4.4%
3/68 • Number of events 5 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Infections and infestations
Biliary sepsis
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Infections and infestations
Biliary tract infection
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Infections and infestations
Urinary tract infection pseudomonal
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Infections and infestations
COVID-19
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Blood bilirubin increased
|
2.9%
2/68 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 5 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Platelet count decreased
|
1.5%
1/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Weight decreased
|
1.5%
1/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
SARS-CoV-2 test positive
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Metabolism and nutrition disorders
Hyperlipasaemia
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 4 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.5%
1/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Nervous system disorders
Hepatic encephalopathy
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Nervous system disorders
Neuropathy peripheral
|
1.5%
1/68 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Nervous system disorders
Meningorrhagia
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Psychiatric disorders
Confusional state
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.9%
2/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
1/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
1.5%
1/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Skin and subcutaneous tissue disorders
Stevens-Johnson syndrome
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Skin and subcutaneous tissue disorders
Diabetic foot
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Vascular disorders
Capillary leak syndrome
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
Other adverse events
| Measure |
Regorafenib+Pembrolizumab [1L: Atezolizumab + Bevacizumab]
n=68 participants at risk
Cohort 1 with participants after one systemic line of therapy consisting of atezolizumab plus bevacizumab treatment combination only. Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks (Q6W). Regorafenib was given orally (p.o.) at a starting dose of 90 mg once daily (QD) for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
Regorafenib+Pembrolizumab [Any Other IO Containing Treatment]
n=27 participants at risk
Cohort 2 with participants after one systemic line of therapy consisting of any PD-1/PD-L1 immune oncology (IO) containing first line treatment (excluding atezolizumab with or without bevacizumab) in monotherapy or combination regimens. Pembrolizumab 400 mg was administered as an intravenous (IV) infusion every 6 weeks (Q6W). Regorafenib was given orally (p.o.) at a starting dose of 90 mg once daily (QD) for 3 weeks of every 4 weeks (i.e., 3 weeks on, 1 week off). If the starting dose of 90 mg daily was well tolerated the dose was escalated to 120 mg starting after the first 4-week cycle of regorafenib.
|
|---|---|---|
|
General disorders
Fatigue
|
20.6%
14/68 • Number of events 21 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
14.8%
4/27 • Number of events 6 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Blood and lymphatic system disorders
Anaemia
|
16.2%
11/68 • Number of events 22 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 12 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Endocrine disorders
Hypothyroidism
|
7.4%
5/68 • Number of events 5 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Abdominal pain
|
22.1%
15/68 • Number of events 17 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
18.5%
5/27 • Number of events 9 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.9%
4/68 • Number of events 6 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
14.8%
4/27 • Number of events 6 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Ascites
|
7.4%
5/68 • Number of events 9 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
11.1%
3/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Constipation
|
20.6%
14/68 • Number of events 17 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
18.5%
5/27 • Number of events 6 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.8%
23/68 • Number of events 37 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
48.1%
13/27 • Number of events 34 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Dry mouth
|
8.8%
6/68 • Number of events 6 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
11.1%
3/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.4%
3/68 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
11.1%
3/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Nausea
|
19.1%
13/68 • Number of events 15 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
18.5%
5/27 • Number of events 8 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Stomatitis
|
7.4%
5/68 • Number of events 9 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Gastrointestinal disorders
Vomiting
|
13.2%
9/68 • Number of events 10 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
11.1%
3/27 • Number of events 4 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
Asthenia
|
33.8%
23/68 • Number of events 52 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
66.7%
18/27 • Number of events 54 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
Mucosal inflammation
|
13.2%
9/68 • Number of events 9 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
14.8%
4/27 • Number of events 6 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
Oedema peripheral
|
11.8%
8/68 • Number of events 9 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
General disorders
Pyrexia
|
19.1%
13/68 • Number of events 16 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
18.5%
5/27 • Number of events 9 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.9%
4/68 • Number of events 7 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Infections and infestations
COVID-19
|
4.4%
3/68 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
22.2%
6/27 • Number of events 7 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Alanine aminotransferase increased
|
5.9%
4/68 • Number of events 4 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
11.1%
3/27 • Number of events 8 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Aspartate aminotransferase increased
|
13.2%
9/68 • Number of events 16 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
11.1%
3/27 • Number of events 7 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Blood bilirubin increased
|
13.2%
9/68 • Number of events 13 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
22.2%
6/27 • Number of events 23 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
2.9%
2/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Lipase increased
|
4.4%
3/68 • Number of events 7 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Weight decreased
|
10.3%
7/68 • Number of events 8 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
14.8%
4/27 • Number of events 8 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Transaminases increased
|
5.9%
4/68 • Number of events 4 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Investigations
Blood alkaline phosphatase increased
|
5.9%
4/68 • Number of events 8 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
0.00%
0/27 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
8.8%
6/68 • Number of events 19 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.3%
7/68 • Number of events 13 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
30.9%
21/68 • Number of events 32 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
48.1%
13/27 • Number of events 22 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.1%
13/68 • Number of events 14 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
37.0%
10/27 • Number of events 20 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
7/68 • Number of events 12 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.4%
3/68 • Number of events 4 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
8/68 • Number of events 8 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Nervous system disorders
Dizziness
|
2.9%
2/68 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Nervous system disorders
Headache
|
7.4%
5/68 • Number of events 6 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Nervous system disorders
Sciatica
|
1.5%
1/68 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Psychiatric disorders
Insomnia
|
8.8%
6/68 • Number of events 7 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
14.8%
4/27 • Number of events 4 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
6/68 • Number of events 6 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
11.1%
3/27 • Number of events 4 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
19.1%
13/68 • Number of events 16 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
18.5%
5/27 • Number of events 7 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.9%
4/68 • Number of events 4 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 3 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.4%
5/68 • Number of events 6 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.4%
3/68 • Number of events 4 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
14.8%
4/27 • Number of events 4 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.4%
5/68 • Number of events 5 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
3.7%
1/27 • Number of events 1 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/68 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
7.4%
2/27 • Number of events 2 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
39.7%
27/68 • Number of events 64 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
51.9%
14/27 • Number of events 24 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
7/68 • Number of events 9 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
18.5%
5/27 • Number of events 6 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.7%
10/68 • Number of events 16 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
22.2%
6/27 • Number of events 12 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
|
Vascular disorders
Hypertension
|
22.1%
15/68 • Number of events 23 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
33.3%
9/27 • Number of events 20 • These data extend to the final release date of the clinical database (38 months).
All-Cause Mortality, Serious Adverse Events (SAEs) and Other Adverse Events were monitored from the start of study intervention until 30 days after the last administration of any study intervention. SAEs were additionally monitored for 90 days after last pembrolizumab infusion, unless a new anti-cancer therapy was initiated. All-Cause Mortality was also additionally monitored for 90 days after last pembrolizumab infusion.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60