Trial Outcomes & Findings for Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN (NCT NCT04034225)
NCT ID: NCT04034225
Last Updated: 2023-03-24
Results Overview
Number of adverse events including adverse events of special interest as assessed by CTCAE v5.0
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
25 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-03-24
Participant Flow
Participants were required to provide archival biopsy material or have a fresh biopsy prior to dosing.
Participant milestones
| Measure |
SNS-301 Added to Pembrolizumab
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
Reasons for withdrawal
| Measure |
SNS-301 Added to Pembrolizumab
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
|---|---|
|
Overall Study
Death
|
3
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Study termination by Sponsor
|
18
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
Baseline Characteristics
Addition of SNS-301 to Checkpoint Inhibitor Treatment in Metastatic/Recurrent SCCHN
Baseline characteristics by cohort
| Measure |
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD
n=21 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy
n=4 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 7.42 • n=39 Participants
|
53.3 years
STANDARD_DEVIATION 13.10 • n=41 Participants
|
61.1 years
STANDARD_DEVIATION 8.92 • n=35 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
5 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
20 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
4 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
21 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
25 Participants
n=35 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of adverse events including adverse events of special interest as assessed by CTCAE v5.0
Outcome measures
| Measure |
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD
n=21 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy
n=4 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
|---|---|---|
|
Number of Participants With Adverse Events of SNS-301 in Addition to Pembrolizumab
|
16 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 12 weeksObjective response rate based on best objective response during the study. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Outcome measures
| Measure |
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD
n=18 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy
n=1 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
|---|---|---|
|
Objective Response Rate by RECIST and iRECIST
Partial Response
|
1 Participants
|
0 Participants
|
|
Objective Response Rate by RECIST and iRECIST
Stable Disease
|
8 Participants
|
1 Participants
|
|
Objective Response Rate by RECIST and iRECIST
Progressive Disease
|
9 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: A total of 18 patients were evaluable in patients who had previous pembrolizumab group and 1 patient was evaluable in the CPI naive group. One patient had a partial response with a DOR of 48.3 weeks. All other patients had stable disease or has progressive disease at the 12 week timeframe.
Duration of response calculated from date of first response to date of progression. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Outcome measures
| Measure |
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD
n=18 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy
n=1 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
|---|---|---|
|
Duration of Response by RECIST 1.1 and iRECIST
|
48.3 weeks
only 1 participant with a partial response which was 48.3 weeks.
|
0 weeks
no participants met the criteria for efficacy.
|
PRIMARY outcome
Timeframe: 12 weeksDisease control rate calculated as the proportion of patients with stable disease or better. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Outcome measures
| Measure |
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD
n=18 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy
n=1 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
|---|---|---|
|
Disease Control Rate by RECIST 1.1 and iRECIST
|
9 participants
|
1 participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: 19/25 patients were evaluable for this assessment.
Progression free survival calculated from the date of start of treatment to date of progression. Objective tumor response definitions included: Complete response (CR): Disappearance of all target lesions, Partial response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters, Progressive disease (PD): At least a 20% increase in the sum of diameters of the target lesions, taking as reference the smallest sum on study (nadir), including baseline. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm and Stable disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum on study.
Outcome measures
| Measure |
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD
n=18 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy
n=1 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
|---|---|---|
|
Progression Free Survival by RECIST 1.1 and iRECIST
|
9 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: Study stopped prematurely; no patients were assessed at 36 months thus no data collected. At the time of termination, four deaths occurred in the patients previously receiving pembrolizumab group and no deaths in the CPI naive group.
Overall survival calculated from date of treatment to date of death.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: 16/25 patients were evaluable for this assessment.
Measure levels at pretreatment, changes during treatment and at progression or end of study
Outcome measures
| Measure |
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD
n=15 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy
n=1 Participants
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
|---|---|---|
|
Antigen-specific Response
|
0 ASPH antigen-specific responders
|
0 ASPH antigen-specific responders
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated.
Determine TCR diversity pretreatment, changes during treatment and at progression or end of study
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated.
Determine gene signature pretreatment, during treatment and at progression
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 weeksPopulation: Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated.
Measure levels at pretreatment, changes during treatment and at progression or end of study
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated.
Determine immune expression pretreatment, changes during treatment and at progression
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated.
Determine expression pretreatment, during treatment and at progression
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated.
Determine pretreatment expression, changes during treatment and at progression
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated.
Determine cytokine/chemokine profile pretreatment, changes during treatment and at progression
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 12 weeksPopulation: Blood samples were collected. However, due to the lack of ASPH-specific T-cell responses in patients treated with SNS-301 and the subsequent discontinuation of the clinical trial, the samples were not analyzed and no data were generated.
Determine ctDNA profile pretreatment, changes during treatment and at progression
Outcome measures
Outcome data not reported
Adverse Events
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD
Serious events: 5 serious events
Other events: 16 other events
Deaths: 3 deaths
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD
n=21 participants at risk
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy
n=4 participants at risk
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Nervous system disorders
Cerebrovascular accident
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/21 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
25.0%
1/4 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Systemic inflammatory response syndrome
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
Other adverse events
| Measure |
SNS-301 Added to Pembrolizumab in Participants on a CPI >12 Weeks With a BOR SD/uPD
n=21 participants at risk
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
SNS-301 Added to Pembrolizumab in Participants CPI Naive/ First Line Systemic Therapy
n=4 participants at risk
* SNS-301
* Pembrolizumab
SNS-301: Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
Pembrolizumab: Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Nervous system disorders
Dizziness
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Nervous system disorders
Aphasia
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Nervous system disorders
Hypoaesthesia
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Renal and urinary disorders
Acute kidney injury
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Reproductive system and breast disorders
Perineal pain
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.0%
4/21 • Number of events 4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal swelling
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
3/21 • Number of events 3 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Skin and subcutaneous tissue disorders
Blister
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Vascular disorders
Hypertension
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Vascular disorders
Flushing
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Vascular disorders
Haematoma
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Cardiac disorders
Tachycardia
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Ear and labyrinth disorders
Ear pain
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/21 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
25.0%
1/4 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Eye disorders
Blindness
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Nausea
|
14.3%
3/21 • Number of events 3 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
25.0%
1/4 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
3/21 • Number of events 3 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Constipation
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Diarrhoea
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Dyspepsia
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Mouth hemorrhage
|
0.00%
0/21 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
25.0%
1/4 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Fatigue
|
19.0%
4/21 • Number of events 4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
25.0%
1/4 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Asthenia
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Cyst
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Injection site discomfort
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Mass
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Non-cardiac chest pain
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Oedema
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Oedema peripheral
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Secretion discharge
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
General disorders
Swelling face
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Infections and infestations
Abscess
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Infections and infestations
Ear infection
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Infections and infestations
Rash pustular
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Infections and infestations
Vaginal infection
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Injury, poisoning and procedural complications
Fall
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Investigations
Weight decreased
|
14.3%
3/21 • Number of events 3 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Investigations
White blood cell count increased
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Investigations
Blood alkaline phosphatase increased
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Investigations
Blood thyroid stimulating hormone increased
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Investigations
Electrocardiogram QT prolongation
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Investigations
Urine output decreased
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Decreased appetite
|
23.8%
5/21 • Number of events 5 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/21 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
25.0%
1/4 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Metabolism and nutrition disorders
Malnutrition
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
9.5%
2/21 • Number of events 2 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.8%
1/21 • Number of events 1 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
0.00%
0/4 • AEs were collected from study entry through 30 days post the patient's last dose. On average, patients were on the study for 3.3 months.
AE definition as per clinicaltrials.gov definition
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Submission of data for publication/presentation will be reviewed, coordinated and approved by Sensei in collaboration with the Investigator.
- Publication restrictions are in place
Restriction type: OTHER