Trial Outcomes & Findings for Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas (NCT NCT03136055)
NCT ID: NCT03136055
Last Updated: 2022-12-27
Results Overview
ORR is defined as the percentage of participants in the analysis population who demonstrated complete response (CR) or partial response (PR) radiographically according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by investigator. The analysis will include all subjects treated (ITT) who received at least one dose of the study treatment. If the final study consists of both Part A and Part B, the analysis will be done separately for each part.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
Approximately 2 years
Results posted on
2022-12-27
Participant Flow
Participant milestones
| Measure |
Part A: Pembrolizumab Only
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first).
|
Part B: Pembrolizumab + Chemotherapy
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m\^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
22
|
|
Overall Study
COMPLETED
|
14
|
22
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pembrolizumab-based Therapy in Previously Treated High Grade Neuroendocrine Carcinomas
Baseline characteristics by cohort
| Measure |
Part A: Pembrolizumab Only
n=14 Participants
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first).
|
Part B: Pembrolizumab + Chemotherapy
n=22 Participants
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m\^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
30-39 years old
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
40-49 years old
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Customized
50-59 years old
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Customized
60-69 years old
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Age, Customized
70-79 years old
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=5 Participants
|
22 participants
n=7 Participants
|
36 participants
n=5 Participants
|
|
Received prior platinum-based therapy
|
14 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 yearsORR is defined as the percentage of participants in the analysis population who demonstrated complete response (CR) or partial response (PR) radiographically according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 as assessed by investigator. The analysis will include all subjects treated (ITT) who received at least one dose of the study treatment. If the final study consists of both Part A and Part B, the analysis will be done separately for each part.
Outcome measures
| Measure |
Part A: Pembrolizumab Only
n=14 Participants
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first).
|
Part B: Pembrolizumab + Chemotherapy
n=22 Participants
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m\^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
7 percentage of participants
Interval 0.02 to 33.9
|
5 percentage of participants
Interval 0.0 to 22.8
|
SECONDARY outcome
Timeframe: Over the duration of the study, which is estimated to be approximately 32 months.Overall survival is defined as the time from the first day of study treatment with protocol therapy to the date of death due to any cause. Kaplan-Meier method will be used to summarize OS. Median OS and its 95% confidence interval will be obtained for Part A and B (if available) separately.
Outcome measures
| Measure |
Part A: Pembrolizumab Only
n=14 Participants
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first).
|
Part B: Pembrolizumab + Chemotherapy
n=22 Participants
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m\^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion.
|
|---|---|---|
|
Overall Survival (OS)
|
7.8 months
Interval 3.1 to
There were insufficient number of events so the upper limit of the confidence interval could not be calculated.
|
4.8 months
Interval 4.1 to 8.2
|
SECONDARY outcome
Timeframe: Over the duration of the study, which is estimated to be approximately 32 months.Population: Only 1 participant in Part A, and 1 participant in Part B obtained CR or PR
Duration of Response is defined as the time from the date of first response (CR or PR) until the date of disease progression or death. Duration of response will be reported for Part A and B (if available) separately. Only patients who have a demonstrated response will be used in final analysis.
Outcome measures
| Measure |
Part A: Pembrolizumab Only
n=1 Participants
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first).
|
Part B: Pembrolizumab + Chemotherapy
n=1 Participants
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m\^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion.
|
|---|---|---|
|
Duration of Response (DOR)
|
18.9 months
|
6.71 months
|
SECONDARY outcome
Timeframe: Over the duration of the study, which is estimated to be approximately 32 months.Progression free survival is defined as the time from the first day of study treatment with protocol therapy to the date of documented tumor progression or death due to any cause, whichever occurs first, as determined by RECIST v1.1 for PFS. Subjects who did not progress or die will be censored on the date of their last evaluable tumor assessment. Kaplan-Meier method will be used to summarize progression median PFS with 95% confidence interval for Part A and B (if available) separately.
Outcome measures
| Measure |
Part A: Pembrolizumab Only
n=14 Participants
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first).
|
Part B: Pembrolizumab + Chemotherapy
n=22 Participants
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m\^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion.
|
|---|---|---|
|
Progression Free Survival (PFS)
|
1.8 months
Interval 1.7 to 21.4
|
2 months
Interval 1.9 to 3.4
|
Adverse Events
Part A: Pembrolizumab Only
Serious events: 1 serious events
Other events: 14 other events
Deaths: 11 deaths
Part B: Pembrolizumab + Chemotherapy
Serious events: 6 serious events
Other events: 22 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Part A: Pembrolizumab Only
n=14 participants at risk
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first).
|
Part B: Pembrolizumab + Chemotherapy
n=22 participants at risk
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m\^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14 • Up to 32 months
|
13.6%
3/22 • Number of events 3 • Up to 32 months
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14 • Up to 32 months
|
13.6%
3/22 • Number of events 3 • Up to 32 months
|
|
General disorders
Fever
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
General disorders
Pain
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Infections and infestations
Infections and infestations - Other
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Investigations
Creatinine increased
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Psychiatric disorders
Confusion
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
General disorders
Edema limbs
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
General disorders
Multi-organ failure
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Infections and infestations
Sepsis
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
Other adverse events
| Measure |
Part A: Pembrolizumab Only
n=14 participants at risk
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first).
|
Part B: Pembrolizumab + Chemotherapy
n=22 participants at risk
Participants will receive 200 mg of pembrolizumab via IV over 30 minutes every 3 weeks for 24 months or 35 administrations (whichever comes first) and chemotherapy treatment of 125 mg/m\^2 of irinotecan via IV on days 1 and 8 of each 21-day cycle or paclitaxel via IV on days 1, 8, and 15 of each 21-day cycle per physician discretion.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
35.7%
5/14 • Number of events 5 • Up to 32 months
|
45.5%
10/22 • Number of events 11 • Up to 32 months
|
|
Gastrointestinal disorders
Diarrhea
|
14.3%
2/14 • Number of events 3 • Up to 32 months
|
54.5%
12/22 • Number of events 20 • Up to 32 months
|
|
Gastrointestinal disorders
Nausea
|
28.6%
4/14 • Number of events 4 • Up to 32 months
|
45.5%
10/22 • Number of events 11 • Up to 32 months
|
|
Gastrointestinal disorders
Constipation
|
35.7%
5/14 • Number of events 5 • Up to 32 months
|
31.8%
7/22 • Number of events 9 • Up to 32 months
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
2/14 • Number of events 2 • Up to 32 months
|
36.4%
8/22 • Number of events 12 • Up to 32 months
|
|
Gastrointestinal disorders
Dyspepsia
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
9.1%
2/22 • Number of events 3 • Up to 32 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Gastrointestinal disorders
Bloating
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 3 • Up to 32 months
|
|
Gastrointestinal disorders
Gastroparesis
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
General disorders
Fatigue
|
57.1%
8/14 • Number of events 11 • Up to 32 months
|
68.2%
15/22 • Number of events 23 • Up to 32 months
|
|
General disorders
Pain
|
35.7%
5/14 • Number of events 6 • Up to 32 months
|
18.2%
4/22 • Number of events 6 • Up to 32 months
|
|
General disorders
Fever
|
0.00%
0/14 • Up to 32 months
|
27.3%
6/22 • Number of events 7 • Up to 32 months
|
|
General disorders
Edema limbs
|
14.3%
2/14 • Number of events 2 • Up to 32 months
|
13.6%
3/22 • Number of events 4 • Up to 32 months
|
|
General disorders
Infusion related reaction
|
14.3%
2/14 • Number of events 3 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
General disorders
Flu like symptoms
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
General disorders
Multi-organ failure
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Investigations
Alanine aminotransferase increased
|
42.9%
6/14 • Number of events 57 • Up to 32 months
|
68.2%
15/22 • Number of events 55 • Up to 32 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/14 • Up to 32 months
|
40.9%
9/22 • Number of events 11 • Up to 32 months
|
|
Investigations
Alkaline phosphatase increased
|
21.4%
3/14 • Number of events 8 • Up to 32 months
|
13.6%
3/22 • Number of events 8 • Up to 32 months
|
|
Investigations
Aspartate aminotransferase increased
|
28.6%
4/14 • Number of events 10 • Up to 32 months
|
9.1%
2/22 • Number of events 3 • Up to 32 months
|
|
Investigations
Weight loss
|
14.3%
2/14 • Number of events 2 • Up to 32 months
|
18.2%
4/22 • Number of events 5 • Up to 32 months
|
|
Investigations
Creatinine increased
|
21.4%
3/14 • Number of events 10 • Up to 32 months
|
9.1%
2/22 • Number of events 4 • Up to 32 months
|
|
Investigations
Platelet count decreased
|
14.3%
2/14 • Number of events 5 • Up to 32 months
|
13.6%
3/22 • Number of events 4 • Up to 32 months
|
|
Investigations
White blood cell decreased
|
7.1%
1/14 • Number of events 2 • Up to 32 months
|
18.2%
4/22 • Number of events 6 • Up to 32 months
|
|
Investigations
Blood bilirubin increased
|
7.1%
1/14 • Number of events 3 • Up to 32 months
|
13.6%
3/22 • Number of events 3 • Up to 32 months
|
|
Investigations
Lymphocyte count decreased
|
14.3%
2/14 • Number of events 5 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Investigations
International Normalized Ratio (INR) increased
|
14.3%
2/14 • Number of events 3 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Metabolism and nutrition disorders
Anorexia
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
22.7%
5/22 • Number of events 6 • Up to 32 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14 • Up to 32 months
|
27.3%
6/22 • Number of events 10 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
21.4%
3/14 • Number of events 4 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.4%
3/14 • Number of events 10 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
14.3%
2/14 • Number of events 3 • Up to 32 months
|
9.1%
2/22 • Number of events 3 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
21.4%
3/14 • Number of events 5 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
14.3%
2/14 • Number of events 4 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
7.1%
1/14 • Number of events 3 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
7.1%
1/14 • Number of events 2 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
7.1%
1/14 • Number of events 5 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.1%
1/14 • Number of events 2 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
42.9%
6/14 • Number of events 7 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
21.4%
3/14 • Number of events 5 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
0.00%
0/14 • Up to 32 months
|
13.6%
3/22 • Number of events 3 • Up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 3 • Up to 32 months
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
18.2%
4/22 • Number of events 4 • Up to 32 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
14.3%
2/14 • Number of events 2 • Up to 32 months
|
13.6%
3/22 • Number of events 4 • Up to 32 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
9.1%
2/22 • Number of events 3 • Up to 32 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Blood and lymphatic system disorders
Anemia
|
14.3%
2/14 • Number of events 6 • Up to 32 months
|
36.4%
8/22 • Number of events 17 • Up to 32 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 6 • Up to 32 months
|
|
Cardiac disorders
Sinus tachycardia
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
4.5%
1/22 • Number of events 2 • Up to 32 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Renal and urinary disorders
Acute kidney injury
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Renal and urinary disorders
Urinary frequency
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Hepatobiliary disorders
Hepatic failure
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Infections and infestations
Sepsis
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Ear and labyrinth disorders
Ear Pain
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Endocrine disorders
Hypothyroidism
|
7.1%
1/14 • Number of events 3 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Injury, poisoning and procedural complications
Bruising
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
2/14 • Number of events 2 • Up to 32 months
|
18.2%
4/22 • Number of events 7 • Up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
18.2%
4/22 • Number of events 4 • Up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
14.3%
2/14 • Number of events 3 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Psychiatric disorders
Insomnia
|
14.3%
2/14 • Number of events 2 • Up to 32 months
|
18.2%
4/22 • Number of events 4 • Up to 32 months
|
|
Psychiatric disorders
Anxiety
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
13.6%
3/22 • Number of events 3 • Up to 32 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
|
Psychiatric disorders
Agitation
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Endocrine disorders
Endocrine disorders - Other
|
7.1%
1/14 • Number of events 1 • Up to 32 months
|
0.00%
0/22 • Up to 32 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Nervous system disorders
Headache
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Nervous system disorders
Memory Impairment
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Eye disorders
Dry Eye
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Gastrointestinal disorders
Gastrointestinal Hemorrhage
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 3 • Up to 32 months
|
|
General disorders
Chills
|
0.00%
0/14 • Up to 32 months
|
4.5%
1/22 • Number of events 1 • Up to 32 months
|
|
Investigations
Thrombocytopenia
|
0.00%
0/14 • Up to 32 months
|
9.1%
2/22 • Number of events 2 • Up to 32 months
|
Additional Information
Dr. Emily Bergsland
University of California, San Francisco
Phone: (415) 353-9888
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place