Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms
Study Details
Study Description
Brief Summary
This study will evaluate intracystic NanoPac® (Sterile Nanoparticulate Paclitaxel) administered via endoscopic ultrasound-guided fine needle injection (EUS-FNI) in subjects with mucinous cystic pancreatic neoplasms.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Phase 2 |
Detailed Description
In this open-label, dose rising trial, subjects with mucinous cystic pancreatic neoplasms will receive intracystic NanoPac® via endoscopic ultrasound-guided fine needle injection (EUS-FNI).
In the dose escalation phase, subjects will be enrolled in sequential cohorts of NanoPac® at 6, 10, and 15 mg/mL at volumes sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated. Each cohort will have three subjects, with cohorts enrolled sequentially starting at the lowest concentration. Following Data Safety Monitoring Board (DSMB) review of the cohort data, the next cohort may begin enrolling, an additional three at the current dose may be enrolled, or if the first dose does not provide adequate safety and tolerability the study may be halted. The dose determined to be the most suitable for further evaluation, defined as the highest dose with an acceptable safety and tolerability profile (as determined by the DSMB), will be the dose used in the second phase of the study which will enroll 9 additional subjects. Subjects enrolled in the second phase of the study will also receive a second injection of NanoPac at the same dose 12 weeks after the first NanoPac injection..
Plasma samples will be taken on the day(s) of NanoPac® injection at 1 and 2 hours after injection, as well as at each of the subsequent study visits, to characterize the pharmacokinetics (PK) of intracystic NanoPac®.
Subjects will be followed for 6 months after the first NanoPac® injection for safety, tolerability and cyst response to therapy (as shown by imaging).
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Dose Escalation: NanoPac® 6 mg/mL Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated |
Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
|
Experimental: Dose Escalation: NanoPac® 10 mg/mL Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated |
Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
|
Experimental: Dose Escalation: NanoPac® 15 mg/mL Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated |
Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
|
Experimental: Second Phase: NanoPac® at Best Dose Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive two NanoPac® injections, with the second injection administered 12 weeks after the first injection. |
Drug: NanoPac®
NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) [Up to 6 (six) months after first NanoPac® injection]
Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Secondary Outcome Measures
- Cyst Volume Response [Screening and 6 (six) months after first NanoPac® injection]
Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Signed informed consent;
-
Patients over the age of 18;
-
Recently confirmed mucinous cystic pancreatic neoplasm; may be confirmed by presence of mucin, cyst fluid carcinoembryonic antigen (CEA) above 192 U/L, or other reliable diagnostic means such as endomicroscopy; KRAS analysis may also be performed at the discretion of the Investigator;
-
Unilocular cyst with diameter of at least 1.5 cm but no more than 4 cm;
-
Normal hematologic, hepatic, and renal function at study entry;
-
Appropriate steps taken to minimize or avoid the potential for pregnancy for subjects of child-bearing potential.*
-
Note: A female patient is considered to be of childbearing potential unless she has had a hysterectomy, is at least one year postmenopausal or has undergone tubal ligation. For the purposes of this study, adequate birth control includes at least one medically approved and highly effective method of birth control, defined as those which result in a low failure rate (i.e., < 1% per year) when used consistently and correctly, such as implants, injectables and oral contraceptives combined with the use of condoms. Only male patients whose vasectomy has been confirmed by semen analysis at least 3 months after the vasectomy are allowed not to use acceptable contraceptive methods.
Exclusion Criteria:
-
Positive cytology indicating malignancy;
-
Thrombotic or embolic events;
-
Known hypersensitivity to study agent;
-
Known drug or alcohol abuse;
-
Pregnant or breastfeeding women.
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Parkview Cancer Institute | Fort Wayne | Indiana | United States | 46845 |
2 | The Ohio State University, Wexner Medical Center | Columbus | Ohio | United States | 43210 |
3 | Texas Tech University Health Sciences Center | El Paso | Texas | United States | 79905 |
4 | Baylor College of Medicine | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- NanOlogy, LLC
- US Biotest, Inc.
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- NANOPAC-2017-01
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) |
---|---|---|---|---|
Arm/Group Description | Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection. NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) |
Period Title: Overall Study | ||||
STARTED | 3 | 3 | 3 | 11 |
COMPLETED | 3 | 3 | 3 | 10 |
NOT COMPLETED | 0 | 0 | 0 | 1 |
Baseline Characteristics
Arm/Group Title | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | Total |
---|---|---|---|---|---|
Arm/Group Description | Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection. NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Total of all reporting groups |
Overall Participants | 3 | 3 | 3 | 10 | 19 |
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
66.3
(8.3)
|
73.7
(11.5)
|
59.7
(9.1)
|
67.8
(6.6)
|
67.2
(8.4)
|
Sex: Female, Male (Count of Participants) | |||||
Female |
3
100%
|
2
66.7%
|
2
66.7%
|
6
60%
|
13
68.4%
|
Male |
0
0%
|
1
33.3%
|
1
33.3%
|
4
40%
|
6
31.6%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
3
30%
|
3
15.8%
|
Not Hispanic or Latino |
3
100%
|
3
100%
|
3
100%
|
7
70%
|
16
84.2%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Race (NIH/OMB) (Count of Participants) | |||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
2
66.7%
|
0
0%
|
0
0%
|
1
10%
|
3
15.8%
|
White |
1
33.3%
|
3
100%
|
3
100%
|
8
80%
|
15
78.9%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
1
10%
|
1
5.3%
|
Body Mass Index (BMI) (kg/m2) (kg/m2) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [kg/m2] |
34.83
(11.71)
|
27.93
(10.20)
|
26.67
(3.43)
|
32.82
(7.17)
|
31.39
(7.91)
|
Outcome Measures
Title | Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability) |
---|---|
Description | Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs. |
Time Frame | Up to 6 (six) months after first NanoPac® injection |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) |
---|---|---|---|---|
Arm/Group Description | Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection. NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) |
Measure Participants | 3 | 3 | 3 | 10 |
Count of Participants [Participants] |
3
100%
|
3
100%
|
3
100%
|
9
90%
|
Title | Cyst Volume Response |
---|---|
Description | Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination). |
Time Frame | Screening and 6 (six) months after first NanoPac® injection |
Outcome Measure Data
Analysis Population Description |
---|
In the dose escalation phase, baseline imaging data for the measurement of cyst diameters and calculation of cyst volume was available in all subjects. At Week 12, 18 of 19 subjects had three cyst diameters available for analyses. At Week 24, 17 of 19 subjects had three cyst diameters available for analyses. |
Arm/Group Title | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) |
---|---|---|---|---|
Arm/Group Description | Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection. NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) |
Measure Participants | 3 | 3 | 3 | 10 |
Screening |
7.770
(3.283)
|
4.810
(5.109)
|
10.960
(8.484)
|
11.442
(8.132)
|
Week 12 |
5.710
(3.892)
|
3.453
(2.188)
|
9.633
(9.284)
|
12.293
(10.755)
|
Week 24/EOS |
4.140
(3.920)
|
4.383
(0.521)
|
8.533
(7.183)
|
11.138
(11.931)
|
Adverse Events
Time Frame | AEs were collected at all study visits from the time of dosing (Day 1 through Week 24). | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | ||||
Arm/Group Description | Single intracystic injection of NanoPac® at a dose of 6 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Single intracystic injection of NanoPac® at a dose of 10 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Single intracystic injection of NanoPac® at a dose of 15 mg/mL in a volume sufficient to fill the cyst, at least equal to the amount of cyst fluid aspirated NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | Intracystic injection of NanoPac®. The dose administered in the second phase will be determined during the dose escalation phase. Subjects will receive up to two NanoPac® injections, with the second injection administered 12 weeks after the first injection. NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI) | ||||
All Cause Mortality |
||||||||
Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) | 0/10 (0%) | ||||
Serious Adverse Events |
||||||||
Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/3 (33.3%) | 0/3 (0%) | 1/3 (33.3%) | 3/10 (30%) | ||||
Gastrointestinal disorders | ||||||||
Abdominal Pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/10 (0%) | 0 |
Obstruction Gastric | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Breast Cancer | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Nervous system disorders | ||||||||
Hepatic encephalopathy | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Organising pneumonia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
Dose Escalation: NanoPac® 6 mg/mL | Dose Escalation: NanoPac® 10 mg/mL | Dose Escalation: NanoPac® 15 mg/mL | Second Phase: NanoPac® 15 mg/mL (Up to Two Injections) | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 3/3 (100%) | 3/3 (100%) | 3/3 (100%) | 9/10 (90%) | ||||
Cardiac disorders | ||||||||
Atrial Fibrillation | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Gastrointestinal disorders | ||||||||
Abdominal discomfort | 2/3 (66.7%) | 2 | 2/3 (66.7%) | 3 | 1/3 (33.3%) | 1 | 0/10 (0%) | 0 |
Abdominal distension | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Abdominal pain | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/10 (10%) | 1 |
Abdominal pain lower | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Abdominal pain upper | 0/3 (0%) | 0 | 2/3 (66.7%) | 3 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Diarrhoea | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Duodenal ulcer, obstructive | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
GI Motility disorder | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/10 (0%) | 0 |
Glossodynia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Ileal stenosis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Nausea | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 3 | 1/3 (33.3%) | 1 | 1/10 (10%) | 1 |
Obstruction gastric | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Oesophagitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Vomiting | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
General disorders | ||||||||
Asthenia | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/10 (0%) | 0 |
Chills | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Device complication | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Fatigue | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 3 | 1/10 (10%) | 1 |
Hernia pain | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Oedema peripheral | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 1/10 (10%) | 2 |
Pyrexia | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Infections and infestations | ||||||||
Bacterial infection | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Infected bite | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Sinusitis | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 2 |
URTI | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
UTI | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 2 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Vulvovaginal mycotic infec. | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Injury, poisoning and procedural complications | ||||||||
Contusion | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/3 (66.7%) | 2 | 0/10 (0%) | 0 |
Post procedural complication | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Procedural pain | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 2/10 (20%) | 2 |
Investigations | ||||||||
Platelet count increased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
WBC count decreased | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Metabolism and nutrition disorders | ||||||||
Decreased appetite | 1/3 (33.3%) | 1 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Gout | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 2 |
Hyperkalaemia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Musculoskeletal and connective tissue disorders | ||||||||
Medial tibial stress syndrome | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Muscular weakness | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Musculoskeletal discomfort | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Myopathy | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Pain in extremity | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Breast cancer | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Nervous system disorders | ||||||||
Dizziness | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 2/3 (66.7%) | 2 | 0/10 (0%) | 0 |
Headache | 0/3 (0%) | 0 | 2/3 (66.7%) | 4 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Hepatic encephalopathy | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Migraine | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Neuropathy peripheral | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Radiculopathy | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Renal and urinary disorders | ||||||||
Nephrolithiasis | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/3 (0%) | 0 | 0/10 (0%) | 0 |
Respiratory, thoracic and mediastinal disorders | ||||||||
Bradypnoea | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/10 (0%) | 0 |
Organising pneumonia | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Wheezing | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/3 (33.3%) | 1 | 0/10 (0%) | 0 |
Skin and subcutaneous tissue disorders | ||||||||
Pruritus | 2/3 (66.7%) | 2 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Rash | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 0/3 (0%) | 0 | 1/10 (10%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Gere S. diZerega, MD |
---|---|
Organization | US Biotest, Inc. |
Phone | 805.595.1300 |
gere.dizerega@usbiotest.com |
- NANOPAC-2017-01