Trial Outcomes & Findings for Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients (NCT NCT03120832)
NCT ID: NCT03120832
Last Updated: 2021-11-12
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
12 participants
Primary outcome timeframe
Through the 21 day interval after the first dose of vaccine
Results posted on
2021-11-12
Participant Flow
Participant milestones
| Measure |
Cohort 1
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10\^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10\^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 2
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10\^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 3
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10\^11 particles/administration intradermally once every 21 days.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 1 Trial of PAN-301-1 (SNS-301) in Cancer Patients
Baseline characteristics by cohort
| Measure |
Cohort 1
n=3 Participants
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10\^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10\^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 2
n=3 Participants
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10\^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 3
n=6 Participants
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10\^11 particles/administration intradermally once every 21 days.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Age, Continuous
|
67 years
STANDARD_DEVIATION 1.73 • n=93 Participants
|
67 years
STANDARD_DEVIATION 6.24 • n=4 Participants
|
72.8 years
STANDARD_DEVIATION 9.62 • n=27 Participants
|
69.9 years
STANDARD_DEVIATION 7.68 • n=483 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=93 Participants
|
3 participants
n=4 Participants
|
6 participants
n=27 Participants
|
12 participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Through the 21 day interval after the first dose of vaccineOutcome measures
| Measure |
Cohort 1
n=3 Participants
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10\^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10\^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 2
n=3 Participants
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10\^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 3
n=6 Participants
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10\^11 particles/administration intradermally once every 21 days.
|
|---|---|---|---|
|
Safety Assessed by Development of Adverse Events and Dose-limiting Toxicity to Determine Maximum Tolerated Dose
No Dose Limiting Toxicity Observed
|
3 Participants
|
3 Participants
|
6 Participants
|
|
Safety Assessed by Development of Adverse Events and Dose-limiting Toxicity to Determine Maximum Tolerated Dose
Dose Limiting Toxicity Observed
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety Assessed by Development of Adverse Events and Dose-limiting Toxicity to Determine Maximum Tolerated Dose
Maximum Tolerated Dose Reached
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Through study completion, an average of 3 months. Patients were able to continue on treatment with one patient receiving approximately 15 months of treatment.Outcome measures
| Measure |
Cohort 1
n=3 Participants
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10\^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10\^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 2
n=3 Participants
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10\^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 3
n=6 Participants
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10\^11 particles/administration intradermally once every 21 days.
|
|---|---|---|---|
|
Safety Assessed by Administration Site Reactions, Abnormal Laboratory Values and/or Adverse Events
Subjects with treatment related adverse events observed
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Safety Assessed by Administration Site Reactions, Abnormal Laboratory Values and/or Adverse Events
Subjects with no treatment related adverse events observed
|
2 Participants
|
1 Participants
|
6 Participants
|
Adverse Events
Cohort 1
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort 3
Serious events: 1 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10\^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10\^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 2
n=3 participants at risk
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10\^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 3
n=6 participants at risk
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10\^11 particles/administration intradermally once every 21 days.
|
|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo positional
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Nervous system disorders
Demyelination
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
Other adverse events
| Measure |
Cohort 1
n=3 participants at risk
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 2.0 x 10\^10 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 10\^11 particles/administration intradermally once every 21 days. Then from 11th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 2
n=3 participants at risk
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 1.0 x 10\^11 particles/administration intradermally once every 21 days. Then from 6th treatment visit escalated within same patient to dose 3 X 10\^11 particles/administration intradermally once every 21 days.
|
Cohort 3
n=6 participants at risk
PAN-301-1 vaccine is administered intradermally in 3 cohorts of patients in a dose escalation schema every 21 days In this cohort it is administered as SNS-301 3.0 x 10\^11 particles/administration intradermally once every 21 days.
|
|---|---|---|---|
|
Cardiac disorders
Hypertension
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
33.3%
2/6 • Number of events 2 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
General disorders
Fatigue
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Immune system disorders
Injection site erythema
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
33.3%
1/3 • Number of events 2 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Infections and infestations
Herpes Zoster
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Infections and infestations
Tinea cruris
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Cardiac disorders
Infarction
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Infections and infestations
Bronchitis
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
General disorders
Chest pain
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
General disorders
Generalized Oedema
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
General disorders
Oedema peripheral
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
General disorders
Peripheral Swelling
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Skin and subcutaneous tissue disorders
Rash Erythematous
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Eye disorders
Cataract
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Gastrointestinal disorders
Constipation
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Metabolism and nutrition disorders
Hypochloremia
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
33.3%
1/3 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/6 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Renal and urinary disorders
Cystitis hemorrhagic
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
0.00%
0/3 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
16.7%
1/6 • Number of events 1 • Adverse events were collected up to 6 months after last dose/visit, a total of about 640 days since the start of the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place