Trial Outcomes & Findings for Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia (NCT NCT03015532)
NCT ID: NCT03015532
Last Updated: 2025-03-07
Results Overview
Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-48 is 0-480.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
285 participants
Primary outcome timeframe
48 hours
Results posted on
2025-03-07
Participant Flow
Participant milestones
| Measure |
Cohort 1, Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
|
Cohort 1, Group 2: HTX-011
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).
|
Cohort 1, Group 3: Saline Placebo
Saline placebo via injection.
|
Cohort 1, Group 4: Bupivacaine HCI
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
Cohort 2, Group 1: HTX-011
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
|
Cohort 2, Group 2: HTX-011 + Ropivacaine
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
|
Cohort 2, Group 3: Saline Placebo
Saline placebo via injection.
|
Cohort 2, Group 4: Bupivacaine HCI
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
22
|
11
|
10
|
58
|
56
|
53
|
55
|
|
Overall Study
COMPLETED
|
20
|
22
|
11
|
10
|
58
|
54
|
51
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1, Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
|
Cohort 1, Group 2: HTX-011
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).
|
Cohort 1, Group 3: Saline Placebo
Saline placebo via injection.
|
Cohort 1, Group 4: Bupivacaine HCI
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
Cohort 2, Group 1: HTX-011
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
|
Cohort 2, Group 2: HTX-011 + Ropivacaine
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
|
Cohort 2, Group 3: Saline Placebo
Saline placebo via injection.
|
Cohort 2, Group 4: Bupivacaine HCI
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
2
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Total Knee Arthroplasty Infiltration Study for Postoperative Analgesia
Baseline characteristics by cohort
| Measure |
Cohort 1, Group 1: HTX-011
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
|
Cohort 1, Group 2: HTX-011
n=22 Participants
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).
|
Cohort 1, Group 3: Saline Placebo
n=11 Participants
Saline placebo via injection.
|
Cohort 1, Group 4: Bupivacaine HCI
n=10 Participants
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
Cohort 2, Group 1: HTX-011
n=58 Participants
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
|
Cohort 2, Group 2: HTX-011 + Ropivacaine
n=56 Participants
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
|
Cohort 2, Group 3: Saline Placebo
n=53 Participants
Saline placebo via injection.
|
Cohort 2, Group 4: Bupivacaine HCI
n=55 Participants
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
Total
n=285 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
31 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
36 Participants
n=8 Participants
|
38 Participants
n=24 Participants
|
177 Participants
n=42 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
17 Participants
n=8 Participants
|
17 Participants
n=24 Participants
|
108 Participants
n=42 Participants
|
|
Age, Continuous
|
62.1 years
STANDARD_DEVIATION 7.52 • n=5 Participants
|
58.6 years
STANDARD_DEVIATION 7.44 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 4.64 • n=5 Participants
|
65.3 years
STANDARD_DEVIATION 11.62 • n=4 Participants
|
62.5 years
STANDARD_DEVIATION 8.63 • n=21 Participants
|
63.2 years
STANDARD_DEVIATION 9.36 • n=8 Participants
|
61.5 years
STANDARD_DEVIATION 8.31 • n=8 Participants
|
61.4 years
STANDARD_DEVIATION 9.37 • n=24 Participants
|
62.1 years
STANDARD_DEVIATION 8.71 • n=42 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
27 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
147 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
32 Participants
n=21 Participants
|
29 Participants
n=8 Participants
|
28 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
138 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
16 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
16 Participants
n=24 Participants
|
74 Participants
n=42 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
49 Participants
n=21 Participants
|
40 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
39 Participants
n=24 Participants
|
211 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
3 Participants
n=42 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
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
2 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
8 Participants
n=8 Participants
|
7 Participants
n=24 Participants
|
39 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
51 Participants
n=21 Participants
|
49 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
47 Participants
n=24 Participants
|
241 Participants
n=42 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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
United States
|
20 participants
n=5 Participants
|
22 participants
n=7 Participants
|
11 participants
n=5 Participants
|
10 participants
n=4 Participants
|
58 participants
n=21 Participants
|
56 participants
n=8 Participants
|
53 participants
n=8 Participants
|
55 participants
n=24 Participants
|
285 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 48 hoursPopulation: ITT Population
Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-48 is 0-480.
Outcome measures
| Measure |
Cohort 1, Group 1: HTX-011
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
|
Cohort 1, Group 2: HTX-011
n=22 Participants
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).
|
Cohort 1, Group 3: Saline Placebo
n=11 Participants
Saline placebo via injection.
|
Cohort 1, Group 4: Bupivacaine HCI
n=10 Participants
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
Cohort 2, Group 1: HTX-011
n=58 Participants
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
|
Cohort 2, Group 2: HTX-011 + Ropivacaine
n=56 Participants
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
|
Cohort 2, Group 3: Saline Placebo
n=53 Participants
Saline placebo via injection.
|
Cohort 2, Group 4: Bupivacaine HCI
n=55 Participants
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 48 Hours Postsurgery (AUC0-48).
|
386.12 pain intensity score*hr
Standard Deviation 82.930
|
391.56 pain intensity score*hr
Standard Deviation 84.450
|
405.82 pain intensity score*hr
Standard Deviation 97.549
|
347.56 pain intensity score*hr
Standard Deviation 103.422
|
322.08 pain intensity score*hr
Standard Deviation 99.669
|
307.25 pain intensity score*hr
Standard Deviation 127.674
|
396.36 pain intensity score*hr
Standard Deviation 77.468
|
352.74 pain intensity score*hr
Standard Deviation 100.887
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: ITT Population
Pain intensity is assessed at rest using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable" (using windowed worst observation carried forward to adjust for opioid rescue medication use). The theoretical range of AUC0-72 is 0-720.
Outcome measures
| Measure |
Cohort 1, Group 1: HTX-011
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
|
Cohort 1, Group 2: HTX-011
n=22 Participants
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).
|
Cohort 1, Group 3: Saline Placebo
n=11 Participants
Saline placebo via injection.
|
Cohort 1, Group 4: Bupivacaine HCI
n=10 Participants
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
Cohort 2, Group 1: HTX-011
n=58 Participants
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
|
Cohort 2, Group 2: HTX-011 + Ropivacaine
n=56 Participants
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
|
Cohort 2, Group 3: Saline Placebo
n=53 Participants
Saline placebo via injection.
|
Cohort 2, Group 4: Bupivacaine HCI
n=55 Participants
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores at Rest (NRS-R) Through 72 Hours Postsurgery (AUC0-72).
|
543.14 pain intensity score*hr
Standard Deviation 142.566
|
560.85 pain intensity score*hr
Standard Deviation 136.099
|
576.44 pain intensity score*hr
Standard Deviation 150.815
|
468.58 pain intensity score*hr
Standard Deviation 179.687
|
471.19 pain intensity score*hr
Standard Deviation 149.443
|
452.54 pain intensity score*hr
Standard Deviation 194.095
|
577.93 pain intensity score*hr
Standard Deviation 125.102
|
516.93 pain intensity score*hr
Standard Deviation 152.512
|
SECONDARY outcome
Timeframe: 72 hoursPopulation: ITT Population
Outcome measures
| Measure |
Cohort 1, Group 1: HTX-011
n=20 Participants
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
|
Cohort 1, Group 2: HTX-011
n=22 Participants
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation (combination).
|
Cohort 1, Group 3: Saline Placebo
n=11 Participants
Saline placebo via injection.
|
Cohort 1, Group 4: Bupivacaine HCI
n=10 Participants
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
Cohort 2, Group 1: HTX-011
n=58 Participants
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
|
Cohort 2, Group 2: HTX-011 + Ropivacaine
n=56 Participants
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
|
Cohort 2, Group 3: Saline Placebo
n=53 Participants
Saline placebo via injection.
|
Cohort 2, Group 4: Bupivacaine HCI
n=55 Participants
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
|---|---|---|---|---|---|---|---|---|
|
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)
|
65.53 morphine milligram equivalent (MME)
Standard Deviation 31.615
|
66.86 morphine milligram equivalent (MME)
Standard Deviation 31.154
|
70.41 morphine milligram equivalent (MME)
Standard Deviation 18.057
|
60.70 morphine milligram equivalent (MME)
Standard Deviation 29.903
|
64.39 morphine milligram equivalent (MME)
Standard Deviation 27.889
|
60.32 morphine milligram equivalent (MME)
Standard Deviation 34.949
|
73.55 morphine milligram equivalent (MME)
Standard Deviation 34.448
|
68.35 morphine milligram equivalent (MME)
Standard Deviation 29.169
|
Adverse Events
Cohort 1, Group 1: HTX-011
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Cohort 1, Group 2: HTX-011
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
Cohort 1, Group 3: Saline Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Cohort 1, Group 4: Bupivacaine HCI
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Cohort 2, Group 1: HTX-011
Serious events: 1 serious events
Other events: 55 other events
Deaths: 0 deaths
Cohort 2, Group 2: HTX-011 + Ropivacaine
Serious events: 4 serious events
Other events: 50 other events
Deaths: 0 deaths
Cohort 2, Group 3: Saline Placebo
Serious events: 3 serious events
Other events: 50 other events
Deaths: 0 deaths
Cohort 2, Group 4: Bupivacaine HCI
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1, Group 1: HTX-011
n=20 participants at risk
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
|
Cohort 1, Group 2: HTX-011
n=22 participants at risk
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation(combination).
|
Cohort 1, Group 3: Saline Placebo
n=11 participants at risk
Saline placebo via injection.
|
Cohort 1, Group 4: Bupivacaine HCI
n=10 participants at risk
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
Cohort 2, Group 1: HTX-011
n=58 participants at risk
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
|
Cohort 2, Group 2: HTX-011 + Ropivacaine
n=56 participants at risk
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
|
Cohort 2, Group 3: Saline Placebo
n=53 participants at risk
Saline placebo via injection.
|
Cohort 2, Group 4: Bupivacaine HCI
n=55 participants at risk
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Nervous system disorders
Syncope
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.7%
1/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.7%
1/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Vascular disorders
Haematoma
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Infections and infestations
Post procedural cellulitis
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory depression
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
Other adverse events
| Measure |
Cohort 1, Group 1: HTX-011
n=20 participants at risk
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via instillation.
|
Cohort 1, Group 2: HTX-011
n=22 participants at risk
HTX-011 (bupivacaine/meloxicam), 200 mg/6 mg via injection and instillation(combination).
|
Cohort 1, Group 3: Saline Placebo
n=11 participants at risk
Saline placebo via injection.
|
Cohort 1, Group 4: Bupivacaine HCI
n=10 participants at risk
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
Cohort 2, Group 1: HTX-011
n=58 participants at risk
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation.
|
Cohort 2, Group 2: HTX-011 + Ropivacaine
n=56 participants at risk
HTX-011(bupivacaine/meloxicam), 400 mg/12 mg via instillation; Ropivacaine, 50 mg via injection.
|
Cohort 2, Group 3: Saline Placebo
n=53 participants at risk
Saline placebo via injection.
|
Cohort 2, Group 4: Bupivacaine HCI
n=55 participants at risk
Bupivacaine HCl without epinephrine, 125 mg via injection.
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
22.7%
5/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
18.2%
2/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
6.9%
4/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.7%
6/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.2%
3/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.7%
1/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
10.0%
2/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
27.3%
3/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.2%
3/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.7%
6/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
7.5%
4/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.9%
6/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
20.0%
2/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.7%
1/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.6%
2/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
18.2%
4/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
20.0%
2/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.7%
1/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.6%
2/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
13.6%
3/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.7%
1/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.7%
6/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
11.3%
6/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.7%
1/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
7.1%
4/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
7.5%
4/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Nervous system disorders
Dizziness
|
25.0%
5/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
22.7%
5/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
36.4%
4/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
30.0%
3/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
15.5%
9/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
14.3%
8/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
17.0%
9/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
14.5%
8/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Nervous system disorders
Headache
|
15.0%
3/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
13.6%
3/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
18.2%
2/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
6.9%
4/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.6%
2/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
7.3%
4/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Nervous system disorders
Lethargy
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Cardiac disorders
Tachycardia
|
20.0%
4/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
18.2%
4/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
15.5%
9/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
16.1%
9/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
20.8%
11/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.9%
6/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.4%
2/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Vascular disorders
Hypertension
|
10.0%
2/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
13.6%
3/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
40.0%
4/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
19.0%
11/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
14.3%
8/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
15.1%
8/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
12.7%
7/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Vascular disorders
Hypotension
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.2%
3/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.6%
2/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.8%
2/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Gastrointestinal disorders
Nausea
|
70.0%
14/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
72.7%
16/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
54.5%
6/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
40.0%
4/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
50.0%
29/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
53.6%
30/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
47.2%
25/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
54.5%
30/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Gastrointestinal disorders
Constipation
|
40.0%
8/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
45.5%
10/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
18.2%
2/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
30.0%
3/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
24.1%
14/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
37.5%
21/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
22.6%
12/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
32.7%
18/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Gastrointestinal disorders
Vomiting
|
35.0%
7/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
27.3%
6/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
36.4%
4/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
20.0%
2/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
25.9%
15/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
25.0%
14/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
18.9%
10/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
27.3%
15/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.4%
2/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.6%
2/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.7%
3/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.5%
3/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.4%
2/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Gastrointestinal disorders
Dry mouth
|
15.0%
3/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
2/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
20.0%
2/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
6.9%
4/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
7.1%
4/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.5%
3/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
10.0%
2/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
2/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
20.0%
2/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
8.6%
5/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.6%
2/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.4%
5/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.4%
2/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
20.0%
4/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
2/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.2%
3/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.8%
2/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
2/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
6.9%
4/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
7.1%
4/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
11.3%
6/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.6%
2/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Pyrexia
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
22.7%
5/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
20.0%
2/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
13.8%
8/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
14.3%
8/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.8%
2/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
14.5%
8/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Hyperthermia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.4%
2/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.4%
3/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.8%
2/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Medical device site reaction
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
20.0%
2/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.2%
3/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.6%
2/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Feeling cold
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.4%
2/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Chills
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.7%
1/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Oedema peripheral
|
10.0%
2/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
13.6%
3/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.7%
1/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.7%
3/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Peripheral swelling
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
2/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.7%
1/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Asthenia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Pain
|
10.0%
2/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.6%
2/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
6.9%
4/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.4%
2/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.5%
3/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Injury, poisoning and procedural complications
Incision site erythema
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.4%
2/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.8%
2/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Injury, poisoning and procedural complications
Postoperative fever
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.4%
2/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Injury, poisoning and procedural complications
Anaemia postoperative
|
20.0%
4/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
13.6%
3/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
18.2%
2/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
3.6%
2/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.4%
5/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.8%
1/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Surgical and medical procedures
Wound drainage
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
1.9%
1/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Gastrointestinal disorders
Retching
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Inflammation
|
5.0%
1/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
General disorders
Fatigue
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Injury, poisoning and procedural complications
Incision site oedema
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
0.00%
0/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
15.0%
3/20 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
4.5%
1/22 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
9.1%
1/11 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
10.0%
1/10 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
12.1%
7/58 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
5.4%
3/56 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
17.0%
9/53 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
7.3%
4/55 • 28 Days.
Subjects reporting more than one TEAE are counted only once.
|
Additional Information
Vice President, Clinical Operations
Heron Therapeutics, Inc.
Phone: 858-251-7232
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place