Trial Outcomes & Findings for Pembrolizumab for the Treatment of Recurrent High Grade Neuroendocrine Carcinoma (NCT NCT03190213)
NCT ID: NCT03190213
Last Updated: 2021-06-22
Results Overview
Overall response was measured using Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST). At baseline, lesions found on CT or MRI imaging are cataloged as "target" or "non-target" lesions, and the longest dimensions of target lesions (or shortest dimension of target lymph nodes) are summed. irRECIST defines Complete Response (irCR) as a complete disappearance of all lesions after baseline. Partial Response (irPR) is defined as a 30% or more decrease in the target lesion measurements. Overall response rate is defined the percentage of participants with a best response of irCR + irPR.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
6 participants
Primary outcome timeframe
planned for up to two years from baseline; actual time was up to 230 days (average of 70.5 days)
Results posted on
2021-06-22
Participant Flow
Participant milestones
| Measure |
Pembrolizumab: All Patients
Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab for the Treatment of Recurrent High Grade Neuroendocrine Carcinoma
Baseline characteristics by cohort
| Measure |
Pembrolizumab: All Patients
n=6 Participants
Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
44 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: planned for up to two years from baseline; actual time was up to 230 days (average of 70.5 days)Overall response was measured using Immune Related Response Evaluation Criteria in Solid Tumors (irRECIST). At baseline, lesions found on CT or MRI imaging are cataloged as "target" or "non-target" lesions, and the longest dimensions of target lesions (or shortest dimension of target lymph nodes) are summed. irRECIST defines Complete Response (irCR) as a complete disappearance of all lesions after baseline. Partial Response (irPR) is defined as a 30% or more decrease in the target lesion measurements. Overall response rate is defined the percentage of participants with a best response of irCR + irPR.
Outcome measures
| Measure |
Pembrolizumab: All Patients
n=6 Participants
Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
|
|---|---|
|
Overall Response Rate
|
0 percentage of participants
Interval 0.0 to 45.9
|
SECONDARY outcome
Timeframe: planned for up to two years from baseline; actual time was up to 230 days (average of 70.5 days)Clinical benefit was measured using irRECIST. At baseline, lesions found on CT or MRI imaging are cataloged as "target" or "non-target" lesions, and the longest dimensions of target lesions (or shortest dimension of target lymph nodes) are summed. irRECIST defines irCR as a complete disappearance of all lesions after baseline. irPR is defined as a 30% or more decrease in the target lesion measurements. Progressive Disease (irPD) is a defined as a 20% or more increase in target lesion measurements. Stable Disease (irSD) is neither a sufficient shrinkage to qualify as irPR or irCR nor an increase that would qualify as irPD. Clinical Benefit Rate is defined as the percentage of participants with a best response of irCR + irPR + irSD.
Outcome measures
| Measure |
Pembrolizumab: All Patients
n=6 Participants
Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
|
|---|---|
|
Clinical Benefit Rate
|
16.7 percentage of participants
Interval 0.4 to 64.1
|
SECONDARY outcome
Timeframe: planned for up to four years from baseline; actual time was up to 230 days (average of 70.5 days)Progression free survival (PFS) is the length of time during and after treatment that a participant lives and the disease does not get worse. PFS was measured as the time from first dose of pembrolizumab until disease progression by irRECIST criteria (\>= 20% increase in target lesion measurements), and is reported as the median number of days patients survived without disease progression as calculated by the Kaplan-Meier method.
Outcome measures
| Measure |
Pembrolizumab: All Patients
n=6 Participants
Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
|
|---|---|
|
Median Progression Free Survival
|
42.5 days
Interval 40.0 to
Value is infinity because there were too few patients to get a number.
|
SECONDARY outcome
Timeframe: planned for up to four years from baseline; actual time was up to 230 days (average of 70.5 days)Overall survival (OS) is the length of time from the start of treatment that a participant lives. OS was measured as the time from first dose of pembrolizumab until the death of the participant or the end of follow-up (whichever was first), and is reported as the median number of days patients survived as calculated by the Kaplan-Meier method. This study was intended to follow participants up to four years after the initiation of study treatment, but the study and the follow-up period were terminated prematurely. The maximum follow up was 360 days.
Outcome measures
| Measure |
Pembrolizumab: All Patients
n=6 Participants
Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
|
|---|---|
|
Median Overall Survival
|
262 days
Interval 108.0 to
Value is infinity because there were too few patients to get a number.
|
SECONDARY outcome
Timeframe: planned for up to two years of treatment plus 90 days; actual time was up to 338 days (average of 170 days)Adverse Events were reported using the Common Terminology Criteria for Adverse Events (CTCAE) version 4. Each adverse event reported is assigned a severity grade from 1 to 5, where 1 is mild, 2 is moderate, 3 is severe, 4 is life threatening, and 5 indicates the event resulted in death. The number of patients experiencing any Grade 1-2 event and the number of patients experiencing any Grade 3 event are reported. There were no Grade 4 or Grade 5 events reported on this study. AEs were reported during study treatment and up to 90 days after last dose of treatment.
Outcome measures
| Measure |
Pembrolizumab: All Patients
n=6 Participants
Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
|
|---|---|
|
Number of Patients With Adverse Events Reported
Grade 1-2 Event
|
5 Participants
|
|
Number of Patients With Adverse Events Reported
Grade 3 Event
|
5 Participants
|
Adverse Events
Pembrolizumab: All Patients
Serious events: 4 serious events
Other events: 6 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Pembrolizumab: All Patients
n=6 participants at risk
Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
2/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
Other adverse events
| Measure |
Pembrolizumab: All Patients
n=6 participants at risk
Pembrolizumab 200 mg will be administered as an IV infusion every 3 weeks.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
50.0%
3/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Immune system disorders
Allergic reaction
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Anal pain
|
16.7%
1/6 • Number of events 2 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
2/6 • Number of events 3 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Immune system disorders
Autoimmune disorder
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
2/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Dehydration
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
3/6 • Number of events 5 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
16.7%
1/6 • Number of events 2 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Edema limbs
|
33.3%
2/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Fatigue
|
50.0%
3/6 • Number of events 4 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Vascular disorders
Hot flashes
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
16.7%
1/6 • Number of events 2 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Infections and infestations
Infections and infestations - Other: Thrush
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Infusion related reaction
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • Number of events 2 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Investigations
Lymphocyte count decreased
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
4/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Nervous system disorders - Other: Allodynia
|
16.7%
1/6 • Number of events 2 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
General disorders
Pain
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Reproductive system and breast disorders
Pelvic pain
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Rectal pain
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Psychiatric disorders
Restlessness
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Seizure
|
16.7%
1/6 • Number of events 2 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
16.7%
1/6 • Number of events 2 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Nervous system disorders
Spasticity
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • from the first dose of pembrolizumab until 30 days (for other adverse events) or 90 days (for serious adverse events) after last dose of pembrolizumab (average duration of 170 days, max duration of 338 days)
The occurrence of adverse events was sought by non-directive questioning of the patient at each visit or phone contact during the study. Adverse events were also detected when they were volunteered by the patient during or between visits or through physical examination, laboratory test, or other assessments.
|
Additional Information
Data Manager
Huntsman Cancer Institute Research Compliance Office
Phone: 8015850601
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place