Trial Outcomes & Findings for Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms (NCT NCT03188991)
NCT ID: NCT03188991
Last Updated: 2021-06-14
Results Overview
Treatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
20 participants
Primary outcome timeframe
Up to 6 (six) months after first NanoPac® injection
Results posted on
2021-06-14
Participant Flow
Participant milestones
| Measure |
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
NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
|
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
NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
|
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
NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
|
Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
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)
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
3
|
11
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
|
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
NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
|
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
NanoPac®: NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
|
Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
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)
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Intracystic Injection of NanoPac® in Subjects With Mucinous Cystic Pancreatic Neoplasms
Baseline characteristics by cohort
| Measure |
Dose Escalation: NanoPac® 6 mg/mL
n=3 Participants
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)
|
Dose Escalation: NanoPac® 10 mg/mL
n=3 Participants
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)
|
Dose Escalation: NanoPac® 15 mg/mL
n=3 Participants
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)
|
Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
n=10 Participants
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
n=19 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
66.3 years
STANDARD_DEVIATION 8.3 • n=5 Participants
|
73.7 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
59.7 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
67.8 years
STANDARD_DEVIATION 6.6 • n=4 Participants
|
67.2 years
STANDARD_DEVIATION 8.4 • n=21 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Body Mass Index (BMI) (kg/m2)
|
34.83 kg/m2
STANDARD_DEVIATION 11.71 • n=5 Participants
|
27.93 kg/m2
STANDARD_DEVIATION 10.20 • n=7 Participants
|
26.67 kg/m2
STANDARD_DEVIATION 3.43 • n=5 Participants
|
32.82 kg/m2
STANDARD_DEVIATION 7.17 • n=4 Participants
|
31.39 kg/m2
STANDARD_DEVIATION 7.91 • n=21 Participants
|
PRIMARY outcome
Timeframe: Up to 6 (six) months after first NanoPac® injectionTreatment Emergent Adverse Events will include laboratory assessments, physical examination findings, and vital signs.
Outcome measures
| Measure |
Dose Escalation: NanoPac® 6 mg/mL
n=3 Participants
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)
|
Dose Escalation: NanoPac® 10 mg/mL
n=3 Participants
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)
|
Dose Escalation: NanoPac® 15 mg/mL
n=3 Participants
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)
|
Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
n=10 Participants
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)
|
|---|---|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (Safety and Tolerability)
|
3 Participants
|
3 Participants
|
3 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Screening and 6 (six) months after first NanoPac® injectionPopulation: 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.
Cyst volume at screening will be compared with the volume at Weeks 12 and 24 (or early termination).
Outcome measures
| Measure |
Dose Escalation: NanoPac® 6 mg/mL
n=3 Participants
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)
|
Dose Escalation: NanoPac® 10 mg/mL
n=3 Participants
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)
|
Dose Escalation: NanoPac® 15 mg/mL
n=3 Participants
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)
|
Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
n=10 Participants
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)
|
|---|---|---|---|---|
|
Cyst Volume Response
Week 12
|
5.710 mL
Standard Deviation 3.892
|
3.453 mL
Standard Deviation 2.188
|
9.633 mL
Standard Deviation 9.284
|
12.293 mL
Standard Deviation 10.755
|
|
Cyst Volume Response
Week 24/EOS
|
4.140 mL
Standard Deviation 3.920
|
4.383 mL
Standard Deviation 0.521
|
8.533 mL
Standard Deviation 7.183
|
11.138 mL
Standard Deviation 11.931
|
|
Cyst Volume Response
Screening
|
7.770 mL
Standard Deviation 3.283
|
4.810 mL
Standard Deviation 5.109
|
10.960 mL
Standard Deviation 8.484
|
11.442 mL
Standard Deviation 8.132
|
Adverse Events
Dose Escalation: NanoPac® 6 mg/mL
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation: NanoPac® 10 mg/mL
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Dose Escalation: NanoPac® 15 mg/mL
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
Serious events: 3 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose Escalation: NanoPac® 6 mg/mL
n=3 participants at risk
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)
|
Dose Escalation: NanoPac® 10 mg/mL
n=3 participants at risk
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)
|
Dose Escalation: NanoPac® 15 mg/mL
n=3 participants at risk
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)
|
Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
n=10 participants at risk
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)
|
|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast Cancer
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Obstruction Gastric
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
Other adverse events
| Measure |
Dose Escalation: NanoPac® 6 mg/mL
n=3 participants at risk
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)
|
Dose Escalation: NanoPac® 10 mg/mL
n=3 participants at risk
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)
|
Dose Escalation: NanoPac® 15 mg/mL
n=3 participants at risk
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)
|
Second Phase: NanoPac® 15 mg/mL (Up to Two Injections)
n=10 participants at risk
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)
|
|---|---|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
66.7%
2/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
66.7%
2/3 • Number of events 3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Abdominal pain
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
66.7%
2/3 • Number of events 3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
66.7%
2/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Duodenal ulcer, obstructive
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
GI Motility disorder
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Ileal stenosis
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
66.7%
2/3 • Number of events 3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
General disorders
Asthenia
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
General disorders
Chills
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
General disorders
Device complication
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
General disorders
Fatigue
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
66.7%
2/3 • Number of events 3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
General disorders
Hernia pain
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
General disorders
Oedema peripheral
|
66.7%
2/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
66.7%
2/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
General disorders
Pyrexia
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Infections and infestations
Infected bite
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Infections and infestations
URTI
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Infections and infestations
UTI
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Infections and infestations
Vulvovaginal mycotic infec.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
66.7%
2/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
20.0%
2/10 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Investigations
Platelet count increased
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Investigations
WBC count decreased
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Metabolism and nutrition disorders
Decreased appetite
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Metabolism and nutrition disorders
Gout
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Musculoskeletal and connective tissue disorders
Medial tibial stress syndrome
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Musculoskeletal and connective tissue disorders
Myopathy
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Nervous system disorders
Dizziness
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
66.7%
2/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
66.7%
2/3 • Number of events 4 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Nervous system disorders
Migraine
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Nervous system disorders
Neuropathy peripheral
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Nervous system disorders
Radiculopathy
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Respiratory, thoracic and mediastinal disorders
Bradypnoea
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Respiratory, thoracic and mediastinal disorders
Organising pneumonia
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/10 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
66.7%
2/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
10.0%
1/10 • Number of events 1 • AEs were collected at all study visits from the time of dosing (Day 1 through Week 24).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place