NCT04895735 · ADVERSE EVENTS

Adverse events

MC200708 Pemetrexed and Pembrolizumab for the Treatment of Recurrent and/or Metastatic Salivary Gland Cancer · Source last updated 2026-06-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame: Patient mortality was followed for 3 years and adverse events were followed for 27 months
Other-event reporting threshold: 0%

Participants affected / participants at risk, as reported
Safety group	Serious events	Other events	Deaths
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.	3 / 11	10 / 11	2 / 11
Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment 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.	4 / 9	9 / 9	0 / 9
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.	8 / 25	24 / 25	2 / 25

Group identifiers: EG000: Cohort A (Adenoid Cystic Carcinoma) · EG001: Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment · EG002: Cohort B (Non-adenoid Cystic Carcinoma)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Oral cavity fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Upper gastrointestinal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
2
num At Risk
25
num Events
2
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Gen disord and admin site conds-Oth spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Infections and infestations - Oth spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Thrush
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Platelet count decreased

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
5
num At Risk
11
num Events
8
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
11
num At Risk
25
num Events
15
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
18
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
4
num At Risk
25
num Events
22
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
2
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
2
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Hyperparathyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
3
num At Risk
25
num Events
4
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
4
num At Risk
25
num Events
6
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
4
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
2
num At Risk
25
num Events
2
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
4
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Eye disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Eye pain

Complete source fields

event Groups

deaths Num Affected
2
deaths Num At Risk
11
description
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.
id
EG000
other Num Affected
10
other Num At Risk
11
serious Num Affected
3
serious Num At Risk
11
title
Cohort A (Adenoid Cystic Carcinoma)
deaths Num Affected
0
deaths Num At Risk
9
description
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.
id
EG001
other Num Affected
9
other Num At Risk
9
serious Num Affected
4
serious Num At Risk
9
title
Cohort A1 (ACC Patients Enrolled Starting With MCCC Amendment
deaths Num Affected
2
deaths Num At Risk
25
description
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.
id
EG002
other Num Affected
24
other Num At Risk
25
serious Num Affected
8
serious Num At Risk
25
title
Cohort B (Non-adenoid Cystic Carcinoma)

frequency Threshold

other Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
5
num At Risk
11
num Events
8
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
11
num At Risk
25
num Events
15
term
Anemia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
3
num At Risk
11
num Events
18
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
4
num At Risk
25
num Events
22
term
Blood and lymph sys disorders - Oth Spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Sinus bradycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Sinus tachycardia
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
2
term
Ear pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Ear and labyrinth disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
2
term
Vertigo
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Hyperparathyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
3
num At Risk
25
num Events
4
term
Hyperthyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Endocrine disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
4
num At Risk
25
num Events
6
term
Hypothyroidism
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
4
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
2
num At Risk
25
num Events
2
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
4
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Eye disorders - Other, specify
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Eye pain

serious Events

assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Blood and lymphatic system disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Thrombotic thrombocytopenic purpura
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Cardiac disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Heart failure
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Eye disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Blurred vision
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
1
num At Risk
11
num Events
1
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Abdominal pain
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Diarrhea
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Oral cavity fistula
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Gastrointestinal disorders
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Upper gastrointestinal hemorrhage
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
2
num At Risk
11
num Events
2
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
2
num At Risk
25
num Events
2
term
Disease progression
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
General disorders and administration site conditions
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Gen disord and admin site conds-Oth spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Infections and infestations - Oth spec
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Infections and infestations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
1
num At Risk
9
num Events
1
group Id
EG002
num Affected
0
num At Risk
25
num Events
0
term
Thrush
assessment Type
SYSTEMATIC_ASSESSMENT
organ System
Investigations
source Vocabulary
MedDRA 12
stats
group Id
EG000
num Affected
0
num At Risk
11
num Events
0
group Id
EG001
num Affected
0
num At Risk
9
num Events
0
group Id
EG002
num Affected
1
num At Risk
25
num Events
1
term
Platelet count decreased

time Frame

Patient mortality was followed for 3 years and adverse events were followed for 27 months

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Preserved source evidence · Not medical advice