Trial Outcomes & Findings for Pembrolizumab in Patients Failing to Respond to or Relapsing After CAR T Cell Therapy for Relapsed or Refractory Lymphomas (NCT NCT02650999)
NCT ID: NCT02650999
Last Updated: 2021-07-22
Results Overview
Percentage of subjects who discontinued therapy due to dose-limiting toxicity
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
12 participants
Primary outcome timeframe
3 years
Results posted on
2021-07-22
Participant Flow
Participant milestones
| Measure |
Pembrolizumab
Pembrolizumab: 200mg intravenously (IV)
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab in Patients Failing to Respond to or Relapsing After CAR T Cell Therapy for Relapsed or Refractory Lymphomas
Baseline characteristics by cohort
| Measure |
Single Arm
n=12 Participants
Pembrolizumab: 200mg intravenously (IV)
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 3 yearsPercentage of subjects who discontinued therapy due to dose-limiting toxicity
Outcome measures
| Measure |
Single Arm
n=12 Participants
Pembrolizumab: 200mg intravenously (IV)
|
|---|---|
|
Dose-limiting Toxicity
|
8.33 percentage of subjects
Interval 0.4 to 40.2
|
SECONDARY outcome
Timeframe: 3 months3 months Overall response rates
Outcome measures
| Measure |
Single Arm
n=12 Participants
Pembrolizumab: 200mg intravenously (IV)
|
|---|---|
|
Overall Response Rates
|
25 percentage of subjects
Interval 6.7 to 57.2
|
Adverse Events
Single Arm
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm
n=12 participants at risk
Pembrolizumab: 200mg intravenously (IV)
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
acidosis
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Immune system disorders
Cytokine Release Syndrome
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Hepatobiliary disorders
blood bilirubin increased
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Infections and infestations
sepsis
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
hypercalcemia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Psychiatric disorders
delirium
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
General disorders
fever
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
other: odynophagia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
dysphagia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Skin and subcutaneous tissue disorders
rash maculo-papular
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Eye disorders
optic disorder
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Musculoskeletal and connective tissue disorders
non-cardiac chest pain
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
Other adverse events
| Measure |
Single Arm
n=12 participants at risk
Pembrolizumab: 200mg intravenously (IV)
|
|---|---|
|
Cardiac disorders
tachycardia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Cardiac disorders
atrial fibrillation/atrial flutter
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
nausea
|
41.7%
5/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
diarrhea
|
25.0%
3/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
vomiting
|
25.0%
3/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
dry mouth
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
Dysphagia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
GI disorders, other: odynophagia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
Bloating
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
General disorders
fatigue
|
50.0%
6/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
General disorders
fever
|
33.3%
4/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
General disorders
infusion related reaction
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
General disorders
lower extremity edema
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
General disorders
Facial pain
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
General disorders
Facial edema (left side)
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
General disorders
Flank pain
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
General disorders
Flu-like symptoms
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
General disorders
gait disturbance
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Infections and infestations
Infections, other: Zoster
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Infections and infestations
Upper respiratory infection
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Infections and infestations
urinary tract infection
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Neutropenia
|
33.3%
4/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Lymphocyte count decreased
|
58.3%
7/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Anemia
|
33.3%
4/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
INR increased
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
AST elevated
|
41.7%
5/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
ALT elevated
|
33.3%
4/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
thrombocytopenia
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
alkaline phosphatase elevated
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
PTT prolonged
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Blood bilirubin increased
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
WBC decreased
|
25.0%
3/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Investigations - Other, Platelets elevated
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Investigations - Other, WBC increased
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Investigations - Other, ANC increased
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Weight loss
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Investigations, other: low serum total protein
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Investigations, other: elevated urine pH
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Investigations, other: elevated MHC
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Investigations, other: elevated CO2
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Investigations
Blood LDH increased
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
hyperglycemia
|
33.3%
4/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
hypoglycemia
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
hyponatremia
|
25.0%
3/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
hypokalemia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
25.0%
3/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
hypocalcemia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
dehydration
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - other, phosphorus elevated
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Metabolism and nutrition disorders
Anorexia
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Musculoskeletal and connective tissue disorders
Synovitis (MCP, middle finger, left hand)
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Musculoskeletal and connective tissue disorders
pain (back, buttock, right leg / sciatica distribution)
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Musculoskeletal and connective tissue disorders
Non-cardiac chest pain
|
25.0%
3/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Musculoskeletal and connective tissue disorders
Lower back pain
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Nervous system disorders
Neuralgia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Nervous system disorders
Post-herpetic neuralgia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Nervous system disorders
Nervous system - Other, cauda equina syndrome
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Nervous system disorders
Trigeminal nerve disorder
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Psychiatric disorders
Confusion
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Psychiatric disorders
Insomnia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Renal and urinary disorders
Urinary frequency
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Renal and urinary disorders
Hematuria
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Renal and urinary disorders
Proteinuria
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Renal and urinary disorders
urinary hesitancy
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Renal and urinary disorders
Acute kidney injury
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Renal and urinary disorders
urinary retention
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
50.0%
6/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
16.7%
2/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Skin and subcutaneous tissue disorders
rash
|
25.0%
3/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
|
Skin and subcutaneous tissue disorders
Skin disorders, other: inflammation
|
8.3%
1/12 • Adverse events were collected over 2.5 years, from the initiation of the first patient on therapy (June 7, 2016) through treatment of the last patient (January 11, 2019). All adverse events on individual patients were recorded from the time of first dose of pembrolizumab through completion of the Safety Follow Up Visit. SAEs that occured within 90 days of the end of treatment or before initiation of a new anti-cancer treatment were also followed and recorded.
Adverse events were collected by trained research nurse, with attributions assigned by Investigating physician. AEs were recorded in cumulative AE tables, with final review by Principal Investigator at the conclusion of each subject's trial participation.
|
Additional Information
Ellen Napier, Nurse Pracitioner
University of Pennsylvania, Clinical Research Unit
Phone: 215.279.1972
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place