Trial Outcomes & Findings for MC200708 Pemetrexed and Pembrolizumab for the Treatment of Recurrent and/or Metastatic Salivary Gland Cancer (NCT NCT04895735)

NCT ID: NCT04895735

Last Updated: 2026-06-04

Results Overview

Evaluated by Response Evaluation Criteria in Solid Tumors version 1.1.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

45 participants

Primary outcome timeframe

24 weeks

Results posted on

2026-06-04

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort A (Adenoid Cystic Carcinoma) Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort A 1 (Post Amendment 3) Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort B (Non-adenoid Cystic Carcinoma) Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
Overall Study STARTED	11	9	25
Overall Study COMPLETED	11	9	25
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

MC200708 Pemetrexed and Pembrolizumab for the Treatment of Recurrent and/or Metastatic Salivary Gland Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cohort A (Adenoid Cystic Carcinoma) n=11 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment 3) n=9 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort B (Non-adenoid Cystic Carcinoma) n=25 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Total n=45 Participants Total of all reporting groups
Age, Continuous	60 years n=9 Participants	61 years n=27 Participants	60 years n=267 Participants	60 years n=265 Participants
Sex: Female, Male Female	6 Participants n=9 Participants	4 Participants n=27 Participants	8 Participants n=267 Participants	18 Participants n=265 Participants
Sex: Female, Male Male	5 Participants n=9 Participants	5 Participants n=27 Participants	17 Participants n=267 Participants	27 Participants n=265 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=9 Participants	0 Participants n=27 Participants	2 Participants n=267 Participants	4 Participants n=265 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=9 Participants	9 Participants n=27 Participants	23 Participants n=267 Participants	41 Participants n=265 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) Asian	1 Participants n=9 Participants	2 Participants n=27 Participants	0 Participants n=267 Participants	3 Participants n=265 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	1 Participants n=265 Participants
Race (NIH/OMB) Black or African American	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) White	8 Participants n=9 Participants	5 Participants n=27 Participants	24 Participants n=267 Participants	37 Participants n=265 Participants
Race (NIH/OMB) More than one race	0 Participants n=9 Participants	0 Participants n=27 Participants	0 Participants n=267 Participants	0 Participants n=265 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=9 Participants	2 Participants n=27 Participants	1 Participants n=267 Participants	4 Participants n=265 Participants

PRIMARY outcome

Timeframe: 24 weeks

Population: All eligible and treated patients

Evaluated by Response Evaluation Criteria in Solid Tumors version 1.1.

Outcome measures

Outcome measures
Measure	Cohort A (Adenoid Cystic Carcinoma) n=11 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment 3) n=9 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort B (Non-adenoid Cystic Carcinoma) n=24 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
Confirmed Response Rate	0 proportion of participants Interval 0.0 to 0.28	0.11 proportion of participants Interval 0.0 to 0.48	0.375 proportion of participants Interval 0.19 to 0.59

PRIMARY outcome

Timeframe: 24 weeks

CBR will be defined as the rate of patients with stable disease, partial response or complete response as their best response during treatment.

Outcome measures

Outcome measures
Measure	Cohort A (Adenoid Cystic Carcinoma) n=11 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment 3) n=9 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort B (Non-adenoid Cystic Carcinoma) n=24 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
Clinical Benefit Rate (CBR)	0.727 proportion of patients Interval 0.39 to 0.94	1.0 proportion of patients Interval 0.664 to 1.0	0.583 proportion of patients Interval 0.366 to 0.779

SECONDARY outcome

Timeframe: 3 years

Estimated using the Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 months

Estimated using the Kaplan-Meier method.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 27 months

The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The count and percentage of patients that reported a grade 3+ adverse event will be reported.

Outcome measures

Outcome measures
Measure	Cohort A (Adenoid Cystic Carcinoma) n=11 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment 3) n=9 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort B (Non-adenoid Cystic Carcinoma) n=24 Participants Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
Incidence of Adverse Events	8 Participants	8 Participants	19 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Assessed by immunohistochemistry. Will investigate correlation with enhanced response to pemetrexed. The associations of these markers with response will be done via Chi-square or Fisher's exact tests by cohort for categorical biomarkers and done via 2-sample t-tests (or the Wilcoxon Rank-Sum test) by cohort for continuous biomarker data. Descriptive statistics and tables will be reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Will determine the extent of PDL1 expression correlation with response to study treatment. The associations of these markers with response will be done via Chi-square or Fisher's exact tests by cohort for categorical biomarkers and done via 2-sample t-tests (or the Wilcoxon Rank-Sum test) by cohort for continuous biomarker data. Descriptive statistics and tables will be reported.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 3 years

Outcome measures

Outcome data not reported

Adverse Events

Cohort A (Adenoid Cystic Carcinoma)

Serious events: 3 serious events

Other events: 10 other events

Deaths: 2 deaths

Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment

Serious events: 4 serious events

Other events: 9 other events

Deaths: 0 deaths

Cohort B (Non-adenoid Cystic Carcinoma)

Serious events: 8 serious events

Other events: 24 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Katharine Price

Mayo Clinic

Phone: 480-342-4800

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort A (Adenoid Cystic Carcinoma) n=11 participants at risk Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment n=9 participants at risk Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.	Cohort B (Non-adenoid Cystic Carcinoma) n=25 participants at risk Patients receive pembrolizumab IV over 30 minutes and pemetrexed disodium IV over 10 minutes on day 1. Treatment with pembrolizumab repeats every 21 days for up to 35 cycles (2 years) in the absence of disease progression or unacceptable toxicity. Cycles of pemetrexed disodium repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who had stable disease, partial response, or complete response after completion of 35 cycles of pembrolizumab, may continue pembrolizumab for an additional 17 cycles (1 year) in the absence of disease progression or unacceptable toxicity. Patients additionally undergo blood sample collection, CT, PET/CT or MRI and may also undergo PSMA PET on study.
Blood and lymphatic system disorders Thrombotic thrombocytopenic purpura	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	11.1% 1/9 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/25 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Cardiac disorders Heart failure	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Eye disorders Blurred vision	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Gastrointestinal disorders Abdominal pain	9.1% 1/11 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/25 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Gastrointestinal disorders Diarrhea	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	11.1% 1/9 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/25 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Gastrointestinal disorders Oral cavity fistula	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	11.1% 1/9 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/25 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Gastrointestinal disorders Upper gastrointestinal hemorrhage	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
General disorders and administration site conditions Disease progression	18.2% 2/11 • Number of events 2 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	8.0% 2/25 • Number of events 2 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
General disorders and administration site conditions Gen disord and admin site conds-Oth spec	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	11.1% 1/9 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/25 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Vascular disorders Thromboembolic event	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Infections and infestations Infections and infestations - Oth spec	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Infections and infestations Thrush	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	11.1% 1/9 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/25 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Investigations Platelet count decreased	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Metabolism and nutrition disorders Hypokalemia	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	11.1% 1/9 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Nervous system disorders Headache	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Nervous system disorders Transient ischemic attacks	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	11.1% 1/9 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/25 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Renal and urinary disorders Hematuria	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 1/11 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/9 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	11.1% 1/9 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	4.0% 1/25 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months
Respiratory, thoracic and mediastinal disorders Sore throat	0.00% 0/11 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	11.1% 1/9 • Number of events 1 • Patient mortality was followed for 3 years and adverse events were followed for 27 months	0.00% 0/25 • Patient mortality was followed for 3 years and adverse events were followed for 27 months