Trial Outcomes & Findings for Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction (NCT NCT03802396)
NCT ID: NCT03802396
Last Updated: 2024-10-16
Results Overview
Safety of CN-105 administration, as measured by adverse event (AE) rates of Grade II and higher in CN-105 versus placebo-treated patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
203 participants
Primary outcome timeframe
up to 6-week follow-up
Results posted on
2024-10-16
Participant Flow
Participant milestones
| Measure |
CN-105
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Overall Study
STARTED
|
140
|
49
|
|
Overall Study
COMPLETED
|
137
|
49
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
CN-105
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Surgery Cancelled
|
1
|
0
|
Baseline Characteristics
Modulating ApoE Signalling to Reduce Brain Inflammation, deLirium and postopErative Cognitive Dysfunction
Baseline characteristics by cohort
| Measure |
CN-105
n=137 Participants
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=49 Participants
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
Total
n=186 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.4 years
STANDARD_DEVIATION 5.0 • n=99 Participants
|
69.5 years
STANDARD_DEVIATION 6.0 • n=107 Participants
|
68.7 years
STANDARD_DEVIATION 5.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
86 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=99 Participants
|
47 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
122 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
164 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
137 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
186 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: up to 6-week follow-upPopulation: Participants who completed the study.
Safety of CN-105 administration, as measured by adverse event (AE) rates of Grade II and higher in CN-105 versus placebo-treated patients.
Outcome measures
| Measure |
CN-105
n=137 Participants
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=49 Participants
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Number of Adverse Events (AEs) of Grade II or Higher Per Patient
|
1 events per participant
Interval 1.0 to 3.0
|
2 events per participant
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Baseline, 24 hours, approximately 6 weeksPopulation: Participants with data collected at each timepoint.
Change in CSF IL-6 cytokine levels from before to after surgery between drug vs placebo treated patients.
Outcome measures
| Measure |
CN-105
n=137 Participants
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=49 Participants
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Change in Cerebrospinal Fluid (CSF) IL-6 Cytokine Levels Between Drug vs Placebo Treated Patients
Baseline to 24 hours
|
0.52 pg/mL
Interval -0.08 to 1.35
|
0.91 pg/mL
Interval 0.3 to 1.63
|
|
Change in Cerebrospinal Fluid (CSF) IL-6 Cytokine Levels Between Drug vs Placebo Treated Patients
Baseline to 6 weeks
|
-0.06 pg/mL
Interval -0.4 to 0.17
|
0.00 pg/mL
Interval -0.2 to 0.12
|
SECONDARY outcome
Timeframe: Baseline, 24 hours, approximately 6 weeksPopulation: Participants with data collected at each timepoint.
Change in CSF IL-8 cytokine levels from before to after surgery between drug vs placebo treated patients
Outcome measures
| Measure |
CN-105
n=98 Participants
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=37 Participants
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Change in CSF IL-8 Cytokine Levels Between Drug vs Placebo Treated Patients
Baseline to 24 hours
|
130.11 pg/mL
Interval 69.11 to 227.9
|
153.43 pg/mL
Interval 67.44 to 268.26
|
|
Change in CSF IL-8 Cytokine Levels Between Drug vs Placebo Treated Patients
Baseline to 6 weeks
|
-2.7 pg/mL
Interval -8.06 to 0.32
|
0.54 pg/mL
Interval -4.23 to 4.08
|
SECONDARY outcome
Timeframe: Baseline, 24 hours, approximately 6 weeksPopulation: Participants with data collected at each timepoint.
Change in CSF MCP-1 cytokine levels before to after surgery between drug vs placebo treated patients
Outcome measures
| Measure |
CN-105
n=98 Participants
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=37 Participants
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Change in CSF MCP-1 Cytokine Levels Between Drug vs Placebo Treated Patients
Baseline to 24 hours
|
-114.39 pg/mL
Interval -177.58 to -22.06
|
-116.75 pg/mL
Interval -195.11 to -26.95
|
|
Change in CSF MCP-1 Cytokine Levels Between Drug vs Placebo Treated Patients
Baseline to 6 weeks
|
-17.69 pg/mL
Interval -58.01 to 21.33
|
-4.62 pg/mL
Interval -32.16 to 6.32
|
SECONDARY outcome
Timeframe: Baseline, 24 hours, approximately 6 weeksPopulation: Participants who had data collected at each timepoint.
Change in CSF G-CSF cytokine levels before to after surgery between drug vs placebo treated patients.
Outcome measures
| Measure |
CN-105
n=98 Participants
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=37 Participants
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Change in CSF G-CSF Cytokine Levels Between Drug vs Placebo Treated Patients
Baseline to 6 weeks
|
0.22 pg/mL
Interval -1.1 to 1.13
|
-0.23 pg/mL
Interval -0.96 to 0.77
|
|
Change in CSF G-CSF Cytokine Levels Between Drug vs Placebo Treated Patients
Baseline to 24 hours
|
2.46 pg/mL
Interval 0.75 to 6.36
|
3.3 pg/mL
Interval 1.89 to 10.18
|
SECONDARY outcome
Timeframe: Baseline, approximately 6 weeksPopulation: Participants who completed both baseline and 6-week follow-up visit and surgery on protocol.
To characterize cognitive function over time, while minimizing potential redundancy in the cognitive measures, a Z-score standardization was performed on the 11 cognitive test scores with mean and standard deviation derived at the baseline timepoint. We then constructed four summary scores by taking the average of the standardized cognitive test scores, which represent the following cognitive domains: verbal memory, executive function, visual memory and attention. To quantify overall cognitive function, a cognitive index was calculated as the mean of the 4 domain scores. The cognitive index score has a mean of zero, thus any positive score is above the mean, any negative score is below the mean. A continuous change score was then calculated by subtracting the baseline from the 6-week cognitive index. The resulting outcome measure is unbounded with standard deviation of 0.33. A negative change score indicating decline and a positive score indicating improvement.
Outcome measures
| Measure |
CN-105
n=108 Participants
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=35 Participants
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Change in Cognitive Change Index (CCI) Between Drug vs Placebo Treated Patients
|
0.08 units on a scale
Standard Deviation 0.33
|
0.06 units on a scale
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: admission to preoperative holding to hospital discharge (up to postoperative day 4)The feasibility of perioperative CN-105 administration is assessed by tracking the percentage of doses given within the correct time window (i.e. within 1 hour prior to the scheduled or actual start time of the surgery, and within a +/- 90 minute time window for subsequent doses, which are administered every 6 hours after the start of surgery).
Outcome measures
| Measure |
CN-105
n=137 Participants
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=49 Participants
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Feasibility of Drug Administration as Measured by the Percentage of Doses Given Within the Correct Time Window
|
94.6 percentage of doses
Interval 92.9 to 96.0
|
93.8 percentage of doses
Interval 90.8 to 96.0
|
SECONDARY outcome
Timeframe: Baseline, day of surgery (twice), post-operative days 1 - 5 (twice), 6 weeks +/- 3 weeksPopulation: Participants who completed surgery on protocol and had at least 1 postoperative CAM-3D or CAM-ICU assessment performed.
Scores on 3D CAM (non-intubated patients) or CAM ICU (intubated patients) are used to determine whether patients have delirium (yes/no).
Outcome measures
| Measure |
CN-105
n=135 Participants
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=49 Participants
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Number of Participants Who Experience Delirium
|
26 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Baseline, day of surgery (twice), post-operative days 1 - 5 (twice), 6 weeks +/- 3 weeksPopulation: Subjects who completed surgery on protocol and had at least 1 postoperative CAM-3D assessment performed.
Scores on the 3D CAM (in non-intubated patients) are used to determine delirium symptom severity based on a 0 - 20 point scale of the test. Higher scores indicate worse delirium.
Outcome measures
| Measure |
CN-105
n=135 Participants
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=48 Participants
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Peak Severity of Delirium Symptoms Between Drug vs. Placebo Treated Patients
|
1 score on a scale
Interval 1.0 to 2.0
|
2 score on a scale
Interval 1.0 to 2.0
|
Adverse Events
CN-105
Serious events: 11 serious events
Other events: 105 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CN-105
n=137 participants at risk
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=49 participants at risk
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANEMIA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
6.1%
3/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Surgical and medical procedures
CYSTOSCOPY FOR REMOVAL OF URINARY CATHETER
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Psychiatric disorders
DELIRIUM
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Injury, poisoning and procedural complications
FALL
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
General disorders
FATIGUE
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
GASTRIC STENOSIS
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Cardiac disorders
HEART FAILURE EXACERBATION
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Injury, poisoning and procedural complications
HEMORRHAGE
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Vascular disorders
HYPERTENSION
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Vascular disorders
HYPOTENSION
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
6.1%
3/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXEMIA
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
4.1%
2/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
ILEUS
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Injury, poisoning and procedural complications
INTRAOPERATIVE ARTERIAL INJURY
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGEAL EDEMA
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Surgical and medical procedures
MEDICAL PROCEDURE
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Cardiac disorders
MOBITZ TYPE 1 AV BLOCK
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
NAUSEA
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM (METASTATIC SQUAMOUS CELL LUNG CANCER)
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PAIN
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Infections and infestations
PHARYNGITIS/OTALGIA
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
POST-OPERATIVE ILEUS
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS EMPHYSEMA
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
VOMITING
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
Other adverse events
| Measure |
CN-105
n=137 participants at risk
The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses.
|
Placebo
n=49 participants at risk
Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
|
|---|---|---|
|
Injury, poisoning and procedural complications
ABDOMINAL MASS
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
ACIDOSIS
|
2.9%
4/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
ALT INCREASED
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Blood and lymphatic system disorders
ANEMIA
|
21.9%
30/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
18.4%
9/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Psychiatric disorders
ANXIETY
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
AST INCREASED
|
2.2%
3/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Renal and urinary disorders
BLADDER SPASM
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Nervous system disorders
CEREBROSPINAL FLUID LEAKAGE.
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
CONSTIPATION
|
2.2%
3/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
6.1%
3/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
CREATININE INCREASE
|
3.6%
5/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Renal and urinary disorders
CYSTITIS NONINFECTIVE (VS PROSTATITIS, DYSURIA, PROTEINURIA)
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
DECREASED LYMPHOCYTE COUNT
|
19.7%
27/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
30.6%
15/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
DECREASED PLATELET COUNT
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Psychiatric disorders
DELIRIUM
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
4.1%
2/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Psychiatric disorders
DEPRESSION (IE ADJUSTMENT DISORDER WITH ANXIETY AND DEPRESSED MOOD)
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
DIARRHEA
|
2.2%
3/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
4.1%
2/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Nervous system disorders
DIZZINESS
|
2.2%
3/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
10.2%
5/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Surgical and medical procedures
EGD
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Infections and infestations
EPIDIDYMO-ORCHITIS
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMATOUS AREA NOTED IN THE RIGHT ANTECUBITAL FOSSA
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
ESOPHAGEAL ULCER
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Injury, poisoning and procedural complications
FASCIAL DEHISCENCE
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
General disorders
FATIGUE
|
2.2%
3/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
FECAL INCONTINENCE
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
General disorders
FEVER
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
General disorders
FLU LIKE SYMPTOMS
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
GASTROESOPHAGEAL REFLUX-
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Nervous system disorders
HEADACHE
|
2.2%
3/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Renal and urinary disorders
HEMATURIA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
HEMORRHAGE
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Injury, poisoning and procedural complications
HEMORRHAGE
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
HEMORRHAGE
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
HIGH CHEST TUBE OUTPUT
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
HYPERBILIRUBINEMIA
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
HYPERGLYCEMIA
|
2.9%
4/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
12.2%
6/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
2.2%
3/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Vascular disorders
HYPERTENSION
|
44.5%
61/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
44.9%
22/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
HYPOALBUMINEMIA
|
8.0%
11/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
8.2%
4/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
HYPOCALCEMIA
|
7.3%
10/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
6.1%
3/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
HYPOGLYCEMIA
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
HYPONATREMIA
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATEMIA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Vascular disorders
HYPOTENSION
|
8.8%
12/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
6.1%
3/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
3.6%
5/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
4.1%
2/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
ILEUS
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
INCREASED CREATININE
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Infections and infestations
INFECTION
|
12.4%
17/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
12.2%
6/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
General disorders
INFUSION SITE EXTRAVASATION
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
INR INCREASED
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Psychiatric disorders
INSOMNIA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
General disorders
IV INFILTRATION
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
LOW ALBUMIN
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
LOW LYMPH COUNT
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
LOW URINE OUTPUT
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
General disorders
MALAISE
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
MUCOSITIS ORAL
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
2.2%
3/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
NAUSEA
|
4.4%
6/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
8.2%
4/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Renal and urinary disorders
NON-INFECTIVE CYSTITIS
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Surgical and medical procedures
OPERATIVE REPAIR OF EVISCERATION OF BOWEL FROM MIDLINE INCISION
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
PAIN
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
4.1%
2/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
General disorders
PAIN
|
5.1%
7/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
6.1%
3/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Musculoskeletal and connective tissue disorders
PAIN
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
4.1%
2/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Reproductive system and breast disorders
PAIN
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Infections and infestations
PAROTITIS
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Surgical and medical procedures
PERMANENT PACEMAKER PLACEMENT
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
4.1%
2/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Endocrine disorders
POSSIBLE HYPOTHYROIDISM
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Cardiac disorders
POST-OPERATIVE ATRIAL FIBRILLATION
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Skin and subcutaneous tissue disorders
PRURITIS
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EDEMA
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Nervous system disorders
RADICULITIS
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
RIGHT INGUINAL HERNIA
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Metabolism and nutrition disorders
SEVERE PROTEIN CALORIE MALNUTRITION
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Surgical and medical procedures
SHOULDER INJECTION
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Cardiac disorders
SINUS BRADYCARDIA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS EMPHYSEMA
|
2.2%
3/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Nervous system disorders
SYNCOPE
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
4.1%
2/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Social circumstances
TRANSFER TO LONG-TERM CARE FACILITY DUE TO MENTAL ACUITY CONCERN
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Surgical and medical procedures
UNPLANNED SURGICAL PROCEDURE
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
6.1%
3/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Renal and urinary disorders
URINARY RETENTION
|
2.9%
4/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
6.1%
3/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Renal and urinary disorders
URINARY TRACT OBSTRUCTION
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Renal and urinary disorders
URINARY URGENCY
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Investigations
URINE OUTPUT DECREASED
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Skin and subcutaneous tissue disorders
URTICARIA
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Injury, poisoning and procedural complications
VASCULAR ACCESS COMPLICATION
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Nervous system disorders
VASOVAGAL REACTION
|
1.5%
2/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Gastrointestinal disorders
VOMITING
|
3.6%
5/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
10.2%
5/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Reproductive system and breast disorders
VULVOVAGINAL ATROPHY/VAGINAL DRYNESS
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Injury, poisoning and procedural complications
WOUND COMPLICATION
|
0.73%
1/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
0.00%
0/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
|
Injury, poisoning and procedural complications
WOUND DEHISCENCE
|
0.00%
0/137 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
2.0%
1/49 • Surgery to 6-week follow-up visit
Hospital records were reviewed for any CTCAE (v5.0) events rated grade II or higher during index hospitalization or reported to study team members during study follow-up visits.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place