Trial Outcomes & Findings for Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer (NCT NCT03029585)
NCT ID: NCT03029585
Last Updated: 2021-04-27
Results Overview
Adverse events will include any clinically relevant changes in laboratory values, vital signs, and physical examination. Treatment-emergent adverse events occur when the date and time of the adverse event onset is on or after the first application of the investigational agent and any time up to when the intravenous chemotherapy commences. Treatment-emergent adverse events will be summarized for each treatment group. The summaries will include an overall summary of the number of subjects reporting and the number of events reported, summaries of adverse events leading to termination or death, and summaries by severity and relatedness (separately and combined). Of greatest interest will be post-surgery signs of toxicity (e.g., severe abdominal pain after 5-7 days, neutropenia, thrombocytopenia, bowel dehiscence, prolonged ileus).
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
12 months
Results posted on
2021-04-27
Participant Flow
Participant milestones
| Measure |
NanoPac® 100 mg/m2
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
NanoPac® 200 mg/m2
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
3
|
|
Overall Study
COMPLETED
|
5
|
2
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
NanoPac® 100 mg/m2
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
NanoPac® 200 mg/m2
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Phase II Study of Intraperitoneal NanoPac® in Patients With Ovarian Cancer
Baseline characteristics by cohort
| Measure |
NanoPac® 100 mg/m2
n=7 Participants
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
NanoPac® 200 mg/m2
n=3 Participants
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
Total
n=10 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
n=5 Participants
|
62 years
n=7 Participants
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Disease Status
Primary
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Disease Status
Recurrent
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
ECOG Status
ECOG 0
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
ECOG Status
ECOG 1
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Status of Ovarian Cancer at Screening
IIIA2
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Status of Ovarian Cancer at Screening
IIIB
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Status of Ovarian Cancer at Screening
IIIC
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Status of Ovarian Cancer at Screening
IVB
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsAdverse events will include any clinically relevant changes in laboratory values, vital signs, and physical examination. Treatment-emergent adverse events occur when the date and time of the adverse event onset is on or after the first application of the investigational agent and any time up to when the intravenous chemotherapy commences. Treatment-emergent adverse events will be summarized for each treatment group. The summaries will include an overall summary of the number of subjects reporting and the number of events reported, summaries of adverse events leading to termination or death, and summaries by severity and relatedness (separately and combined). Of greatest interest will be post-surgery signs of toxicity (e.g., severe abdominal pain after 5-7 days, neutropenia, thrombocytopenia, bowel dehiscence, prolonged ileus).
Outcome measures
| Measure |
NanoPac® 100 mg/m2
n=7 Participants
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
NanoPac® 200 mg/m2
n=3 Participants
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
|---|---|---|
|
Treatment-emergent Adverse Events
|
80 Treatment Emergent Adverse Events
|
28 Treatment Emergent Adverse Events
|
SECONDARY outcome
Timeframe: 12 monthsPlasma samples will be taken on Day 1 at 1, 2, 4, 8, and 24 hours post-intraperitoneal administration of NanoPac® and weekly thereafter until IV chemotherapy begins. Additionally, a pharmacokinetics (PK) sample will be collected from every subject prior to each cycle of IV chemotherapy for determination of paclitaxel concentrations to assess potential NanoPac® persistence. PK levels of paclitaxel in the plasma will be summarized descriptively.
Outcome measures
| Measure |
NanoPac® 100 mg/m2
n=7 Participants
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
NanoPac® 200 mg/m2
n=3 Participants
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
|---|---|---|
|
Maximum Plasma Concentration of Paclitaxel (Cmax)
|
12.56 ng/mL
Standard Deviation 10.98
|
26.50 ng/mL
Standard Deviation 13.56
|
SECONDARY outcome
Timeframe: 12 months post-treatmentPopulation: Of the 10 subjects enrolled, four subjects were not evaluable for PFS at 12 months post-NanoPac instillation. For one subject, no imaging was performed over the course of the study; one subject was deceased due to leptomeningeal carcinomatosis; one subject was deceased due to a respiratory arrest; and one subject withdrew consent from the study. Both deaths were considered not related to study medication by the Investigator and the Medical Monitor.
Progression free survival (PFS) was assessed every 3 months until the end of the 12-month follow-up period, and every 6 months thereafter until progression or the last subject in the trial has completed 12 months of follow-up. Factors taken into account to determine time-to-progression included CA-125 levels, tumor burden as assessed by imaging and utilizing RECIST version 1.1 for assessment of response, and cancer-related symptoms such as bowel obstruction and ascites.
Outcome measures
| Measure |
NanoPac® 100 mg/m2
n=4 Participants
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
NanoPac® 200 mg/m2
n=2 Participants
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
|---|---|---|
|
Progression Free Survival (PFS) at 12 Months
PFS at 12 months
|
4 Participants
|
0 Participants
|
|
Progression Free Survival (PFS) at 12 Months
Disease Progression
|
0 Participants
|
2 Participants
|
Adverse Events
NanoPac® 100 mg/m2
Serious events: 4 serious events
Other events: 7 other events
Deaths: 1 deaths
NanoPac® 200 mg/m2
Serious events: 3 serious events
Other events: 3 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
NanoPac® 100 mg/m2
n=7 participants at risk
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
NanoPac® 200 mg/m2
n=3 participants at risk
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
|---|---|---|
|
Infections and infestations
Pyelonephritis
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Infections and infestations
Pelvic abscess
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to meninges
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Infections and infestations
Cystitis
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
Other adverse events
| Measure |
NanoPac® 100 mg/m2
n=7 participants at risk
Intraperitoneal NanoPac® 100 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 100 mg/m2: Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
NanoPac® 200 mg/m2
n=3 participants at risk
Intraperitoneal NanoPac® 200 mg/m2 applied immediately post-cytoreductive surgery, followed by standard of care intravenous chemotherapy.
NanoPac® 200 mg/m2: Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
Standard of Care Intravenous Chemotherapy: Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • Number of events 5 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
28.6%
2/7 • Number of events 3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Cardiac disorders
Arrhythmia
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Cardiac disorders
Palpitations
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Gastrointestinal disorders
Abdominal distension
|
28.6%
2/7 • Number of events 2 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Gastrointestinal disorders
Ascites
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Gastrointestinal disorders
Constipation
|
28.6%
2/7 • Number of events 2 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Gastrointestinal disorders
Ileus paralytic
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Gastrointestinal disorders
Nausea
|
42.9%
3/7 • Number of events 5 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
100.0%
3/3 • Number of events 3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • Number of events 3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
66.7%
2/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
General disorders
Administration site extravasation
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
General disorders
Fatigue
|
42.9%
3/7 • Number of events 5 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
General disorders
Pain
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Infections and infestations
Pyelonephritis
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Infections and infestations
Urinary tract infection
|
28.6%
2/7 • Number of events 2 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Injury, poisoning and procedural complications
Incision site pain
|
14.3%
1/7 • Number of events 3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
57.1%
4/7 • Number of events 4 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
66.7%
2/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Investigations
Blood albumin decreased
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Investigations
Blood chloride decreased
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Investigations
Blood urea decreased
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Investigations
Glomerular filtration rate decreased
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Investigations
Haematocrit decreased
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Investigations
Heart rate irregular
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Investigations
Lymphocyte count
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Investigations
Platelet count decreased
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Investigations
Protein total decreased
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Investigations
White blood cell count increased
|
28.6%
2/7 • Number of events 2 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
28.6%
2/7 • Number of events 4 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
14.3%
1/7 • Number of events 2 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 2 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Metabolism and nutrition disorders
Hypokalacaemia
|
28.6%
2/7 • Number of events 2 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
28.6%
2/7 • Number of events 3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Nervous system disorders
Dizziness
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Nervous system disorders
Hypoaesthesia
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Renal and urinary disorders
Haematuria
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/7 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
33.3%
1/3 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
|
Vascular disorders
Hypotension
|
14.3%
1/7 • Number of events 1 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
0.00%
0/3 • AEs were collected at all study visits from the time of dosing until end of study, for a planned 30-month collection period for each subject.
|
Additional Information
Gere S. diZerega, MD, Responsible Medical Officer
US Biotest, Inc.
Phone: 1-805-595-1300
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place