Trial Outcomes & Findings for Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen (NCT NCT03974932)
NCT ID: NCT03974932
Last Updated: 2023-08-31
Results Overview
The Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
116 participants
Primary outcome timeframe
12 through 48 hours
Results posted on
2023-08-31
Participant Flow
Subjects in Cohort 1 and Cohort 2 received the same Assigned Intervention (ie, HTX-011 400 mg/12 mg + celecoxib-containing MMA regimen) and results are pooled for the purpose of this Results Section.
Participant milestones
| Measure |
Cohort 1 and Cohort 2 (Pooled)
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
66
|
14
|
16
|
20
|
|
Overall Study
COMPLETED
|
66
|
14
|
16
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Total Knee Arthroplasty (TKA) Study of HTX-011 in an Multimodal Analgesic Regimen (MMA) Regimen
Baseline characteristics by cohort
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
Total
n=116 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
31 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
62 Participants
n=21 Participants
|
|
Age, Continuous
|
64.0 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 8.88 • n=7 Participants
|
66.8 years
STANDARD_DEVIATION 9.81 • n=5 Participants
|
69.0 years
STANDARD_DEVIATION 8.82 • n=4 Participants
|
65.1 years
STANDARD_DEVIATION 9.64 • n=21 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
65 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
46 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
87 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
59 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
98 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
66 participants
n=5 Participants
|
14 participants
n=7 Participants
|
16 participants
n=5 Participants
|
20 participants
n=4 Participants
|
116 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 through 48 hoursThe Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.
Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Mean Area Under the Curve (AUC) of the Visual Analogue Scale (VAS).
|
155.57 pain intensity score*hr
Standard Deviation 95.651
|
185.27 pain intensity score*hr
Standard Deviation 86.898
|
161.36 pain intensity score*hr
Standard Deviation 86.627
|
126.59 pain intensity score*hr
Standard Deviation 118.431
|
SECONDARY outcome
Timeframe: 72 hoursThe Visual Analog Scale (VAS) consists of a straight 10-cm line that represents pain ranging from "no pain" to "pain as bad as it could be". Subjects were asked to mark their current pain level on the line.
Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Mean AUC of VAS Scores.
|
277.03 pain intensity score*hr
Standard Deviation 164.004
|
319.81 pain intensity score*hr
Standard Deviation 158.746
|
276.87 pain intensity score*hr
Standard Deviation 146.578
|
216.18 pain intensity score*hr
Standard Deviation 206.164
|
SECONDARY outcome
Timeframe: 72 hoursPain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain". NRS scores are measured at rest.
Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Mean AUC of the NRS of Pain Intensity at Rest (NRS-R).
|
309.89 pain intensity score*hr
Standard Deviation 155.289
|
355.20 pain intensity score*hr
Standard Deviation 161.377
|
311.00 pain intensity score*hr
Standard Deviation 136.714
|
245.00 pain intensity score*hr
Standard Deviation 200.369
|
SECONDARY outcome
Timeframe: 24 hours, 48 hours, 72 hoursSevere Pain defined as a VAS score ≥7.5 cm.
Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Percentage of Subjects With Severe Pain.
24 Hours
|
26 Participants
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Percentage of Subjects With Severe Pain.
48 Hours
|
29 Participants
|
5 Participants
|
5 Participants
|
6 Participants
|
|
Percentage of Subjects With Severe Pain.
72 Hours
|
23 Participants
|
5 Participants
|
5 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 72 hoursOutcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Mean Total Postoperative Opioid Consumption (in IV Morphine Milligram Equivalents [MME]).
|
26.40 MME, morphine milligram equivalency
Standard Deviation 23.229
|
31.50 MME, morphine milligram equivalency
Standard Deviation 24.907
|
23.40 MME, morphine milligram equivalency
Standard Deviation 14.484
|
17.62 MME, morphine milligram equivalency
Standard Deviation 22.167
|
SECONDARY outcome
Timeframe: 72 Hours to Day 11Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Percentage of Subjects Who Are Opioid-free
|
25 participants
|
4 participants
|
3 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 72 hours through Day 11Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Percentage of Subjects Who Are Opioid-free Through 72 Hours Who Remain Opioid-free Through Day 11.
|
9 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Through 72 hoursOutcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Median Time to First Opioid Rescue Medication.
|
6.12 Hours
Interval 4.27 to 8.25
|
5.63 Hours
Interval 2.12 to 19.48
|
9.96 Hours
Interval 4.18 to 15.9
|
12.76 Hours
Interval 5.8 to 47.1
|
SECONDARY outcome
Timeframe: 72 hoursOutcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Percentage of Subjects Who do Not Receive an Opioid Prescription at Discharge.
|
41 Participants
|
8 Participants
|
12 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: 72 hours through Day 11Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Percentage of Subjects Who do Not Receive an Opioid Prescription Between Discharge and the Day 11 Visit.
|
44 Participants
|
8 Participants
|
8 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: 24 hours, 48 hours, 72 hours, Day 11Patient's Global Assessment (PGA) of pain control is a 4-point scale in which subjects rate how well their pain has been controlled (0 = Poor; 1 = Fair; 2 = Good; 3 = Excellent).
Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Percentage of Subjects Achieving a Score of "Good" or Better (>1) Pain Control Based on Patient Global Assessment (PGA).
24 Hours
|
60 Participants
|
10 Participants
|
14 Participants
|
16 Participants
|
|
Percentage of Subjects Achieving a Score of "Good" or Better (>1) Pain Control Based on Patient Global Assessment (PGA).
48 Hours
|
61 Participants
|
11 Participants
|
14 Participants
|
16 Participants
|
|
Percentage of Subjects Achieving a Score of "Good" or Better (>1) Pain Control Based on Patient Global Assessment (PGA).
72 Hours
|
66 Participants
|
12 Participants
|
15 Participants
|
18 Participants
|
|
Percentage of Subjects Achieving a Score of "Good" or Better (>1) Pain Control Based on Patient Global Assessment (PGA).
Day 11
|
50 Participants
|
11 Participants
|
11 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: 72 hoursOutcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Median Time to First Ambulation Postsurgery.
|
20.66 Hours
Interval 18.48 to 23.43
|
23.20 Hours
Interval 6.08 to 54.62
|
26.72 Hours
Interval 24.37 to 29.6
|
20.58 Hours
Interval 5.83 to 23.92
|
SECONDARY outcome
Timeframe: 72 hoursOutcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Percentage of Subjects Unable to Participate in Each Rehabilitation Session Because of Pain.
|
23 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, 24, hours, 36 hours, 48 hours, 60 hours, 72 hoursSubjects were assessed for readiness for discharge using the Modified Post-Anesthesia Discharge Scoring System (MPADSS) that assesses 5 clinical variables: vital signs, ambulation, nausea/vomiting, pain, and surgical bleeding, each on a 3-point scale of 0, 1, or 2 with 0 being the worst score and 2 being the best score. Subjects with an MPADSS score of 9 or 10 were considered ready for discharge.
Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Through 2 Hours
|
15 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Through 4 Hours
|
16 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
|
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Through 6 Hours
|
21 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
|
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Through 8 Hours
|
29 Participants
|
6 Participants
|
8 Participants
|
8 Participants
|
|
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Through 12 Hours
|
38 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
|
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Through 24 Hours
|
45 Participants
|
8 Participants
|
11 Participants
|
15 Participants
|
|
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Through 36 Hours
|
52 Participants
|
12 Participants
|
13 Participants
|
18 Participants
|
|
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Through 48 Hours
|
57 Participants
|
12 Participants
|
13 Participants
|
19 Participants
|
|
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Through 60 Hours
|
57 Participants
|
12 Participants
|
15 Participants
|
19 Participants
|
|
Percentage of Subjects Who First Achieve an MPADSS Score ≥9.
Through 72 Hours
|
59 Participants
|
13 Participants
|
15 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: 72 hoursNumber Analyzed represents Subjects who were discharged home.
Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Percentage of Subjects Who Are Discharged Home vs to a Skilled Nursing Facility.
|
61 Participants
|
10 Participants
|
16 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: 24 hours, 48 hours, 72 hours, Day 11Subjects were questioned about their overall benefit of analgesia. Overall benefit of analgesia score (OBAS) assesses current pain at rest, vomiting, itching, sweating, freezing, dizziness, and overall satisfaction with postoperative pain during the previous 24 hours. To calculate the OBAS score, each of the subscale scores (0=minimum; 4=maximum) are summed for a combined OBAS score. Possible scores could range from 0 to 28 with a lower score indicating greater benefit.
Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Mean Overall Benefit of Analgesia Score (OBAS).
24 Hours
|
6.5 Scores on a scale
Standard Deviation 2.75
|
7.4 Scores on a scale
Standard Deviation 6.36
|
7.6 Scores on a scale
Standard Deviation 3.24
|
5.9 Scores on a scale
Standard Deviation 3.45
|
|
Mean Overall Benefit of Analgesia Score (OBAS).
48 Hours
|
5.7 Scores on a scale
Standard Deviation 2.76
|
4.9 Scores on a scale
Standard Deviation 1.44
|
5.9 Scores on a scale
Standard Deviation 2.89
|
5.3 Scores on a scale
Standard Deviation 2.57
|
|
Mean Overall Benefit of Analgesia Score (OBAS).
72 Hours
|
5.1 Scores on a scale
Standard Deviation 2.46
|
4.1 Scores on a scale
Standard Deviation 1.77
|
4.9 Scores on a scale
Standard Deviation 1.88
|
4.8 Scores on a scale
Standard Deviation 2.29
|
|
Mean Overall Benefit of Analgesia Score (OBAS).
Day 11
|
5.0 Scores on a scale
Standard Deviation 2.43
|
5.2 Scores on a scale
Standard Deviation 2.08
|
4.9 Scores on a scale
Standard Deviation 2.08
|
4.9 Scores on a scale
Standard Deviation 2.07
|
SECONDARY outcome
Timeframe: 72 hours through Day 11The Treatment Satisfaction Questionnaire for Medication (TSQM-9) contains 9 items assessing Effectiveness, Convenience, and Global Satisfaction domains. Responses to items are rated on a 5-point or 7-point rating scale. Scores for each domain are computed by adding the TSQM items in each domain and then transforming the values in to a composite score ranging from 0 to 100, with higher scores representing higher satisfaction.
Outcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Mean Total TSQM-9 Score
Global Satisfaction Domain - 72 Hours
|
86.9 Scores on a scale
Standard Deviation 15.53
|
77.0 Scores on a scale
Standard Deviation 22.62
|
89.3 Scores on a scale
Standard Deviation 14.75
|
86.8 Scores on a scale
Standard Deviation 13.57
|
|
Mean Total TSQM-9 Score
Effectiveness Doman - 72 Hours
|
86.4 Scores on a scale
Standard Deviation 18.09
|
80.2 Scores on a scale
Standard Deviation 20.52
|
84.0 Scores on a scale
Standard Deviation 14.61
|
81.9 Scores on a scale
Standard Deviation 15.39
|
|
Mean Total TSQM-9 Score
Convenience Domain - 72 Hours
|
90.1 Scores on a scale
Standard Deviation 12.03
|
84.5 Scores on a scale
Standard Deviation 17.18
|
93.1 Scores on a scale
Standard Deviation 13.07
|
86.9 Scores on a scale
Standard Deviation 16.45
|
|
Mean Total TSQM-9 Score
Global Satisfaction Domain - Day 11
|
78.0 Scores on a scale
Standard Deviation 22.39
|
74.5 Scores on a scale
Standard Deviation 27.27
|
72.8 Scores on a scale
Standard Deviation 21.22
|
82.9 Scores on a scale
Standard Deviation 18.16
|
|
Mean Total TSQM-9 Score
Effectiveness Doman - Day 11
|
76.3 Scores on a scale
Standard Deviation 21.18
|
69.4 Scores on a scale
Standard Deviation 29.13
|
69.4 Scores on a scale
Standard Deviation 29.13
|
67.0 Scores on a scale
Standard Deviation 24.80
|
|
Mean Total TSQM-9 Score
Convenience Domain - Day 11
|
90.1 Scores on a scale
Standard Deviation 12.03
|
86.9 Scores on a scale
Standard Deviation 15.50
|
80.9 Scores on a scale
Standard Deviation 15.31
|
90.6 Scores on a scale
Standard Deviation 12.24
|
SECONDARY outcome
Timeframe: 72 hoursOutcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=65 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Maximum Concentration (Cmax)
Meloxicam
|
238 ng/mL
Standard Deviation 96.8
|
247 ng/mL
Standard Deviation 89.0
|
251 ng/mL
Standard Deviation 104
|
385 ng/mL
Standard Deviation 161
|
|
Maximum Concentration (Cmax)
Bupivacaine
|
566 ng/mL
Standard Deviation 273
|
534 ng/mL
Standard Deviation 175
|
742 ng/mL
Standard Deviation 268
|
851 ng/mL
Standard Deviation 288
|
SECONDARY outcome
Timeframe: 72 hoursOutcome measures
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=65 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 Participants
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Time of Occurrence of Maximum Concentration (Tmax)
Bupivacaine
|
21.05 hours
Interval 1.07 to 49.83
|
20.54 hours
Interval 3.98 to 37.27
|
20.14 hours
Interval 2.1 to 37.02
|
22.48 hours
Interval 8.05 to 48.63
|
|
Time of Occurrence of Maximum Concentration (Tmax)
Meloxicam
|
47.13 hours
Interval 18.38 to 49.83
|
58.58 hours
Interval 23.65 to 73.28
|
37.17 hours
Interval 20.35 to 71.43
|
48.58 hours
Interval 20.85 to 73.37
|
Adverse Events
Cohort 1 and Cohort 2 (Pooled)
Serious events: 2 serious events
Other events: 56 other events
Deaths: 0 deaths
Cohort 3: Group A
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Cohort 3: Group B
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Cohort 4
Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 participants at risk
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 participants at risk
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 participants at risk
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 participants at risk
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Vascular disorders
Hypertension
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Gastrointestinal disorders
Gastritis
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
Other adverse events
| Measure |
Cohort 1 and Cohort 2 (Pooled)
n=66 participants at risk
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group A
n=14 participants at risk
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg + celecoxib-containing MMA regimen.
|
Cohort 3: Group B
n=16 participants at risk
HTX-011 (bupivacaine/meloxicam), 300 mg/9 mg and 100 mg bupivacaine HCl + celecoxib-containing MMA regimen.
|
Cohort 4
n=20 participants at risk
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg + ibuprofen-containing MMA regimen.
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Procedural haemorrhage
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Nervous system disorders
Dizziness
|
13.6%
9/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
12.5%
2/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Nervous system disorders
Headache
|
3.0%
2/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Nervous system disorders
Hypoaesthesia
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Eye disorders
Vision blurred
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
12.5%
2/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Cardiac disorders
Bradycardia
|
4.5%
3/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
21.4%
3/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
12.5%
2/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Cardiac disorders
Tachycardia
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
10.0%
2/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Vascular disorders
Hypertension
|
4.5%
3/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Vascular disorders
Hypotension
|
3.0%
2/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
33/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
42.9%
6/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
68.8%
11/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
30.0%
6/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Gastrointestinal disorders
Vomiting
|
25.8%
17/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
21.4%
3/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
43.8%
7/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
25.0%
5/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Gastrointestinal disorders
Constipation
|
15.2%
10/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
21.4%
3/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
37.5%
6/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
10.0%
2/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.6%
5/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
12.5%
2/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Renal and urinary disorders
Urinary retention
|
4.5%
3/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
21.4%
3/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
General disorders
Oedema peripheral
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
21.4%
3/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
General disorders
Peripheral swelling
|
4.5%
3/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
General disorders
Chest pain
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
General disorders
Asthenia
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Investigations
Blood pressure increased
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Investigations
Blood pressure decreased
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
13.6%
9/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
18.8%
3/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
14.3%
2/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Incision site haemorrhage
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Incision site oedema
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Incision site pruritus
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Postoperative hypertension
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Infections and infestations
Postoperative wound infection
|
6.1%
4/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.5%
3/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
3/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Psychiatric disorders
Insomnia
|
1.5%
1/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
6.2%
1/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
7.1%
1/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/66 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/14 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
0.00%
0/16 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
5.0%
1/20 • From the time the subject signed the informed consent form (ICF) through the Day 29 Visit.
At each level of summarization (any event and Preferred Term), subjects reporting more than one adverse event are counted only once.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place