Trial Outcomes & Findings for Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer (NCT NCT02317705)
NCT ID: NCT02317705
Last Updated: 2022-06-21
Results Overview
Sensitivity for the detection of folate receptor-alpha positive (FRAP) ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAO ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by the pathology/ and immunohistochemistry lab (TP+FN). 95% lower one-sided confidence interval was used.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
Day of Surgery (Day 1)
Results posted on
2022-06-21
Participant Flow
Subjects were screened up to 28 days prior to surgery.
Participant milestones
| Measure |
OTL38 for Intra-operativeImaging of Folate Receptor-alpha Positive Ovarian Cancer
Patient injected with a dose of 0.025 mg/kg OTL38 and undergoes intraoperative imaging
|
|---|---|
|
Overall Study
STARTED
|
48
|
|
Overall Study
Safety Population
|
44
|
|
Overall Study
Modified Intent-to-Treat (mITT)
|
29
|
|
Overall Study
COMPLETED
|
43
|
|
Overall Study
NOT COMPLETED
|
5
|
Reasons for withdrawal
| Measure |
OTL38 for Intra-operativeImaging of Folate Receptor-alpha Positive Ovarian Cancer
Patient injected with a dose of 0.025 mg/kg OTL38 and undergoes intraoperative imaging
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Drug not usable
|
1
|
Baseline Characteristics
Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
Baseline characteristics by cohort
| Measure |
OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
n=44 Participants
Patient injected with a dose of 0.025 mg/kg OTL38 and undergoes intraoperative imaging
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=5 Participants
|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 10.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
37 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of Surgery (Day 1)Population: Population includes all patients who received OTL38, underwent cytoreductive surgery for sensitivity analysis, were exposed to fluorescent light using the imaging system, and had at least one FRAP target ovarian cancer lesion. Patients enrolled to the study after adequate number of lesions have been excised and submitted for pathology, and immunohistochemistry evaluation for determining sensitivity, enrolled after protocol amendment 4, were not included in the analysis population.
Sensitivity for the detection of folate receptor-alpha positive (FRAP) ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAO ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by the pathology/ and immunohistochemistry lab (TP+FN). 95% lower one-sided confidence interval was used.
Outcome measures
| Measure |
Experimental
n=225 lesions
Patient injected with a dose of 0.025 mg/kg OTL38 and undergoes intraoperative imaging
|
|---|---|
|
Sensitivity of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
|
97.97 percentage of lesions
Interval 87.75 to
data are not available to report the upper limit as the 95% lower one sided Confidence Interval is calculated according to the pre-specified analysis plan
|
PRIMARY outcome
Timeframe: Day of Surgery (Day 1)Population: Population includes all patients who received OTL38, underwent cytoreductive surgery for PPV analysis, were exposed to fluorescent light using the imaging system, and had at least one FRAP target ovarian cancer lesion. Patients enrolled to the study after adequate number of lesions have been excised and submitted for pathology, and immunohistochemistry evaluation for determining PPV, enrolled after protocol amendment 4, were not included in the analysis population.
PPV for the detection of FRAP ovarian cancer lesions is defined as the ratio (multiplied by 100) of the number of FRAP ovarian cancer lesions confirmed by both fluorescent light and the pathology/ and immunohistochemistry lab (TP) over the number of FRAP ovarian cancer lesions confirmed by fluorescent light (TP + FP). 95% lower one-sided confidence interval was used.
Outcome measures
| Measure |
Experimental
n=225 lesions
Patient injected with a dose of 0.025 mg/kg OTL38 and undergoes intraoperative imaging
|
|---|---|
|
Positive Predictive Value (PPV) of OTL38 in Detecting Folate Receptor-alpha Positive Ovarian Cancer During Surgery.
|
94.93 percentage of lesions
Interval 86.13 to
data are not available to report the upper limit as the 95% lower one sided Confidence Interval is calculated according to the pre-specified analysis plan
|
Adverse Events
Patients Receiving OTL38
Serious events: 13 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients Receiving OTL38
n=44 participants at risk
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
OTL38
Near infrared camera imaging system: Near infrared camera imaging system
Laparotomy: primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
|
|---|---|
|
Infections and infestations
Postoperative wound infection
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Sepsis
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Clostridium difficile infection
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Haematoma infection
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Pneumonia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Septic Shock
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Wound abscess
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Constipation
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Nausea
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Vomiting
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Plueral effusion
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Vascular disorders
Deep vein thrombosis
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Vascular disorders
Haematoma
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Vascular disorders
Haemorrhage
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
General disorders
Pyrexia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
Other adverse events
| Measure |
Patients Receiving OTL38
n=44 participants at risk
All patients in this arm will receive OTL38 for injection and undergo intraoperative imaging.
OTL38
Near infrared camera imaging system: Near infrared camera imaging system
Laparotomy: primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
27.3%
12/44 • Number of events 14 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Vomiting
|
31.8%
14/44 • Number of events 14 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
4/44 • Number of events 5 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
4/44 • Number of events 5 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
4/44 • Number of events 4 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Dysphagia
|
6.8%
3/44 • Number of events 3 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Ileus
|
6.8%
3/44 • Number of events 3 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Abdominal Pain
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Ascites
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Ileus paralytic
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
90.9%
40/44 • Number of events 40 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
11.4%
5/44 • Number of events 6 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
6.8%
3/44 • Number of events 3 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Bladder injury
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Gastrointestinal anastomotic leak
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Anaemia
|
25.0%
11/44 • Number of events 15 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Urinary tract infection
|
6.8%
3/44 • Number of events 3 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Pneumonia
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Postoperative wound infection
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Sepsis
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Bronchitis
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Cellulitis
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Clostridium difficile infection
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Device related infection
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Haematoma infection
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Incision site cellulitis
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Klebsiella infection
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Lip infection
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Septic shock
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Infections and infestations
Wound abcess
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
15.9%
7/44 • Number of events 7 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
6.8%
3/44 • Number of events 3 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
6.8%
3/44 • Number of events 3 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Fluid overload
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
6.8%
3/44 • Number of events 4 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
General disorders
Pyrexia
|
11.4%
5/44 • Number of events 5 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
General disorders
Fatigue
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
General disorders
Chills
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
General disorders
Malaise
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
General disorders
Oedema peripheral
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Investigations
Electrocardiogram QT prolonged
|
4.5%
2/44 • Number of events 3 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Investigations
Platelet count decreased
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Investigations
Urine output decreased
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Vascular disorders
Hypotension
|
6.8%
3/44 • Number of events 3 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Vascular disorders
Deep vein thrombosis
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Vascular disorders
Haematoma
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Vascular disorders
Haemorrhage
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Cardiac disorders
Sinus tachycardia
|
11.4%
5/44 • Number of events 5 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Cardiac disorders
Tachycardia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Psychiatric disorders
Anxiety
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Psychiatric disorders
Confusional state
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Psychiatric disorders
Delirium
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Psychiatric disorders
Hallucination
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Psychiatric disorders
Insomnia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Acute kidney injury
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Bladder spasm
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Haematuria
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Pollakiuria
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Renal and urinary disorders
Urinary retention
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.5%
2/44 • Number of events 2 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Nervous system disorders
Headache
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Nervous system disorders
Paraesthesia
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Nervous system disorders
Presyncope
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Nervous system disorders
Seizure
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Eye disorders
Lacrimation increased
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.3%
1/44 • Number of events 1 • Adverse events were collected from the time of study drug administration throughout the course of the study, ending with Visit 4. The total collection period for each subject was approximately one month.
The definition of AEs and SAEs for this study was consistent with the clinicaltrials.gov definitions.
|
Additional Information
Tommy Lee, MSHS, Vice President, Clinical Operations
On Target Laboratories
Phone: 765-588-4547
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place