Trial Outcomes & Findings for Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer (NCT NCT01545141)
NCT ID: NCT01545141
Last Updated: 2023-10-27
Results Overview
This will be assessed by the increase in the total number of tumor-infiltrating CD8+ T cells in the resected, recurrent CRC lesions (measured as the ratio between the CD8 mRNA message and the expression of the housekeeping gene HPRT), comparing Arm A and Arm B.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
15 participants
Primary outcome timeframe
Day of surgery: day 8-10
Results posted on
2023-10-27
Participant Flow
9 Patients were enrolled in Phase I. 6 Patients were enrolled in Phase II prior to study termination (funding).
Participant milestones
| Measure |
Surgery Only
Surgical resection only, performed as standard of care for the disease
|
Chemokin Modulatory Regimen (5 MU/m2)
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5, 10, and 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2.
|
Chemokin Modulatory Regimen (10 MU/m2)
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 10 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
|
Chemokin Modulatory Regimen (20 MU/m2)
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
3
|
3
|
7
|
|
Overall Study
COMPLETED
|
2
|
3
|
3
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Chemokine-Modulatory Regimen for Recurrent Resectable Colorectal Cancer
Baseline characteristics by cohort
| Measure |
Surgery Only
n=2 Participants
Surgical resection only, performed as standard of care for the disease
|
Chemokine Modulatory Regimen (5 MU/m2)
n=3 Participants
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5 MU/m2.
|
Chemokine Modulatory Regimen (10 MU/m2)
n=3 Participants
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 10 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 10 MU/m2.
|
Chemokine Modulatory Regimen (20 MU/m2)
n=7 Participants
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 20 MU/m2.
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 4.2 • n=5 Participants
|
62.7 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
60.0 years
STANDARD_DEVIATION 15.9 • n=5 Participants
|
47.1 years
STANDARD_DEVIATION 15.3 • n=4 Participants
|
55.1 years
STANDARD_DEVIATION 15.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
3 participants
n=5 Participants
|
7 participants
n=4 Participants
|
15 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Day of surgery: day 8-10Population: The study was terminated prior to completion of enrollment for Phase II and the T-cell analysis was not completed.
This will be assessed by the increase in the total number of tumor-infiltrating CD8+ T cells in the resected, recurrent CRC lesions (measured as the ratio between the CD8 mRNA message and the expression of the housekeeping gene HPRT), comparing Arm A and Arm B.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 1 weekPopulation: The study was terminated prior to completion of enrollment for Phase II. The Phase II portion of the study involved Surgery alone and Chemokin Modulatory Regimen prior to surgery at 20 MU/m2.
The number of adverse events experienced within 1 week of treatment. This was completed for the Phase II portion of the study.
Outcome measures
| Measure |
Surgery Only
n=2 Participants
Surgical resection only, performed as standard of care for the disease
|
Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2)
n=4 Participants
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 2 dose of 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 20 MU/m2.
|
|---|---|---|
|
Treatment Related Adverse Events
|
0 Participants
|
0 Participants
|
Adverse Events
Surgery Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Chemokin Modulatory Regimen Prior to Surgery (5 MU/m2)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Chemokin Modulatory Regimen Prior to Surgery (10 MU/m2)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2)
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Surgery Only
n=2 participants at risk
Surgical resection only, performed as standard of care for the disease
|
Chemokin Modulatory Regimen Prior to Surgery (5 MU/m2)
n=3 participants at risk
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5 MU/m2.
|
Chemokin Modulatory Regimen Prior to Surgery (10 MU/m2)
n=3 participants at risk
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 10 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 10 MU/m2.
|
Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2)
n=7 participants at risk
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 20 MU/m2.
|
|---|---|---|---|---|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
Other adverse events
| Measure |
Surgery Only
n=2 participants at risk
Surgical resection only, performed as standard of care for the disease
|
Chemokin Modulatory Regimen Prior to Surgery (5 MU/m2)
n=3 participants at risk
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 5 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5 MU/m2.
|
Chemokin Modulatory Regimen Prior to Surgery (10 MU/m2)
n=3 participants at risk
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 10 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 10 MU/m2.
|
Chemokin Modulatory Regimen Prior to Surgery (20 MU/m2)
n=7 participants at risk
Chemokine Modulatory Regimen monday through Friday prior to surgery:
400 mg celecoxib for 5 days IFN by intravenous infusion (IV) (Phase 1 dose escalation of 20 MU/m2) for 5 days Rintatolimod 200 mg by IV infusion for 5 days
Chemokine modulatory regimen: Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 20 MU/m2.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
100.0%
3/3 • Number of events 6 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
28.6%
2/7 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
66.7%
2/3 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/7 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/7 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
100.0%
3/3 • Number of events 3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
42.9%
3/7 • Number of events 3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
28.6%
2/7 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
General disorders
Chills
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
100.0%
3/3 • Number of events 4 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
100.0%
3/3 • Number of events 3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
42.9%
3/7 • Number of events 3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
General disorders
Fatigue
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
66.7%
2/3 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
57.1%
4/7 • Number of events 4 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
General disorders
Fever
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
28.6%
2/7 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
General disorders
Flu like symptoms
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/7 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
General disorders
Pain
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
28.6%
2/7 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
100.0%
3/3 • Number of events 3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/7 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
100.0%
3/3 • Number of events 4 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
42.9%
3/7 • Number of events 3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Investigations
Platelet count decreased
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
100.0%
3/3 • Number of events 3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Investigations
Serum amylase increased
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Investigations
White blood cell decreased
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
66.7%
2/3 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
100.0%
3/3 • Number of events 4 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
28.6%
2/7 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
66.7%
2/3 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/7 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
66.7%
2/3 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
66.7%
2/3 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/7 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
14.3%
1/7 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
33.3%
1/3 • Number of events 1 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/7 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
|
Vascular disorders
Hypertension
|
0.00%
0/2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
66.7%
2/3 • Number of events 2 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
66.7%
2/3 • Number of events 3 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
0.00%
0/7 • The adverse events were measured for 30 days after treatment.
Definitions are as described in clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place