Trial Outcomes & Findings for Phase 2B Upper Extremity Nerve Block Study (NCT NCT03011333)
NCT ID: NCT03011333
Last Updated: 2025-03-07
Results Overview
Pain intensity is assessed 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 AUC0-24 is 0-240. The prescribed activity for NRS-A is keeping the elbows at the side and against the body and then raising both hands in front of the abdomen with hands clasped and holding that position for at least 5 seconds.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
243 participants
Primary outcome timeframe
24 hours
Results posted on
2025-03-07
Participant Flow
A total of 243 subjects received study drug.
Participant milestones
| Measure |
Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
|
Group 2: HTX-011
HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
|
Group 3: HTX-011
HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
|
Group 4: HTX-011
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
|
Group 5: HTX-011
HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
|
Group 6: Bupivacaine HCl
Bupivacaine HCl without epinephrine, 50 mg via nerve block
|
Group 7: Saline Placebo
Saline placebo via nerve block
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
27
|
25
|
47
|
50
|
41
|
41
|
|
Overall Study
COMPLETED
|
12
|
26
|
25
|
46
|
46
|
37
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
4
|
4
|
5
|
Reasons for withdrawal
| Measure |
Group 1: HTX-011
HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
|
Group 2: HTX-011
HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
|
Group 3: HTX-011
HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
|
Group 4: HTX-011
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
|
Group 5: HTX-011
HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
|
Group 6: Bupivacaine HCl
Bupivacaine HCl without epinephrine, 50 mg via nerve block
|
Group 7: Saline Placebo
Saline placebo via nerve block
|
|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
1
|
4
|
4
|
5
|
Baseline Characteristics
Phase 2B Upper Extremity Nerve Block Study
Baseline characteristics by cohort
| Measure |
Group 1: HTX-011
n=12 Participants
HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
|
Group 2: HTX-011
n=27 Participants
HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
|
Group 3: HTX-011
n=25 Participants
HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
|
Group 4: HTX-011
n=47 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
|
Group 5: HTX-011
n=50 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
|
Group 6: Bupivacaine HCl
n=41 Participants
Bupivacaine HCl without epinephrine, 50 mg via nerve block
|
Group 7: Saline Placebo
n=41 Participants
Saline placebo via nerve block
|
Total
n=243 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
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
243 Participants
n=24 Participants
|
|
Age, Categorical
>=65 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
|
|
Age, Continuous
|
31.4 Years
STANDARD_DEVIATION 6.56 • n=5 Participants
|
32.1 Years
STANDARD_DEVIATION 8.51 • n=7 Participants
|
30.5 Years
STANDARD_DEVIATION 5.64 • n=5 Participants
|
30.9 Years
STANDARD_DEVIATION 8.08 • n=4 Participants
|
32.0 Years
STANDARD_DEVIATION 8.64 • n=21 Participants
|
30.4 Years
STANDARD_DEVIATION 7.75 • n=8 Participants
|
31.3 Years
STANDARD_DEVIATION 9.03 • n=8 Participants
|
31.2 Years
STANDARD_DEVIATION 8.01 • n=24 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
50 Participants
n=21 Participants
|
41 Participants
n=8 Participants
|
41 Participants
n=8 Participants
|
243 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
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
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
94 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
24 Participants
n=8 Participants
|
25 Participants
n=8 Participants
|
149 Participants
n=24 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
|
|
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
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
11 Participants
n=24 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
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
7 Participants
n=8 Participants
|
36 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
35 Participants
n=8 Participants
|
32 Participants
n=8 Participants
|
194 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 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
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
27 participants
n=7 Participants
|
25 participants
n=5 Participants
|
47 participants
n=4 Participants
|
50 participants
n=21 Participants
|
41 participants
n=8 Participants
|
41 participants
n=8 Participants
|
243 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 24 hoursPopulation: mITT Population
Pain intensity is assessed 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 AUC0-24 is 0-240. The prescribed activity for NRS-A is keeping the elbows at the side and against the body and then raising both hands in front of the abdomen with hands clasped and holding that position for at least 5 seconds.
Outcome measures
| Measure |
Group 1: HTX-011
n=12 Participants
HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
|
Group 2: HTX-011
n=27 Participants
HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
|
Group 3: HTX-011
n=25 Participants
HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
|
Group 4: HTX-011
n=12 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
|
Group 5: HTX-011
n=50 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
|
Group 6: Bupivacaine HCl
n=41 Participants
Bupivacaine HCl without epinephrine, 50 mg via nerve block
|
Group 7: Saline Placebo
n=41 Participants
Saline placebo via nerve block
|
|---|---|---|---|---|---|---|---|
|
Mean Area Under the Curve (AUC) of the Numeric Rating Scale (NRS) Pain Intensity Scores With Activity (NRS-A) Through 24 Hours Postsurgery (AUC0-24).
|
124.51 pain intensity score*hr
Standard Deviation 59.462
|
136.17 pain intensity score*hr
Standard Deviation 58.598
|
136.76 pain intensity score*hr
Standard Deviation 56.034
|
116.71 pain intensity score*hr
Standard Deviation 52.622
|
114.87 pain intensity score*hr
Standard Deviation 48.214
|
133.83 pain intensity score*hr
Standard Deviation 49.493
|
151.52 pain intensity score*hr
Standard Deviation 46.213
|
SECONDARY outcome
Timeframe: 72 HoursPopulation: mITT Population
Outcome measures
| Measure |
Group 1: HTX-011
n=12 Participants
HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
|
Group 2: HTX-011
n=27 Participants
HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
|
Group 3: HTX-011
n=25 Participants
HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
|
Group 4: HTX-011
n=47 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
|
Group 5: HTX-011
n=50 Participants
HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
|
Group 6: Bupivacaine HCl
n=41 Participants
Bupivacaine HCl without epinephrine, 50 mg via nerve block
|
Group 7: Saline Placebo
n=41 Participants
Saline placebo via nerve block
|
|---|---|---|---|---|---|---|---|
|
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents)
|
38.71 Morphine milligram equivalents (MME)
Standard Deviation 28.650
|
24.39 Morphine milligram equivalents (MME)
Standard Deviation 19.878
|
38.00 Morphine milligram equivalents (MME)
Standard Deviation 19.452
|
28.84 Morphine milligram equivalents (MME)
Standard Deviation 22.603
|
37.46 Morphine milligram equivalents (MME)
Standard Deviation 21.452
|
33.57 Morphine milligram equivalents (MME)
Standard Deviation 23.088
|
36.38 Morphine milligram equivalents (MME)
Standard Deviation 23.275
|
Adverse Events
Group 1: HTX-011
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Group 2: HTX-011
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Group 3: HTX-011
Serious events: 1 serious events
Other events: 23 other events
Deaths: 0 deaths
Group 4: HTX-011
Serious events: 0 serious events
Other events: 43 other events
Deaths: 0 deaths
Group 5: HTX-011
Serious events: 1 serious events
Other events: 47 other events
Deaths: 0 deaths
Group 6: Bupivacaine HCl
Serious events: 2 serious events
Other events: 33 other events
Deaths: 0 deaths
Group 7: Saline Placebo
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: HTX-011
n=12 participants at risk
HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
|
Group 2: HTX-011
n=27 participants at risk
HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
|
Group 3: HTX-011
n=25 participants at risk
HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
|
Group 4: HTX-011
n=47 participants at risk
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
|
Group 5: HTX-011
n=50 participants at risk
HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
|
Group 6: Bupivacaine HCl
n=41 participants at risk
Bupivacaine HCl without epinephrine, 50 mg via nerve block
|
Group 7: Saline Placebo
n=41 participants at risk
Saline placebo via nerve block
|
|---|---|---|---|---|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.0%
1/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Reproductive system and breast disorders
Breast haematoma
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.9%
2/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Product Issues
Device breakage
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.0%
1/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
Other adverse events
| Measure |
Group 1: HTX-011
n=12 participants at risk
HTX-011 (bupivacaine/meloxicam), 60 mg/1.8 mg via nerve block
|
Group 2: HTX-011
n=27 participants at risk
HTX-011(bupivacaine/meloxicam), 120 mg/3.6 mg via nerve block
|
Group 3: HTX-011
n=25 participants at risk
HTX-011(bupivacaine/meloxicam), 240 mg/7.2 mg via nerve block
|
Group 4: HTX-011
n=47 participants at risk
HTX-011 (bupivacaine/meloxicam), 400 mg/12 mg via nerve block
|
Group 5: HTX-011
n=50 participants at risk
HTX-011 (bupivacaine/meloxicam), 400 mg/ 12 mg via instillation
|
Group 6: Bupivacaine HCl
n=41 participants at risk
Bupivacaine HCl without epinephrine, 50 mg via nerve block
|
Group 7: Saline Placebo
n=41 participants at risk
Saline placebo via nerve block
|
|---|---|---|---|---|---|---|---|
|
Nervous system disorders
Dizziness
|
8.3%
1/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
22.2%
6/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
40.0%
10/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
8.5%
4/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
12.0%
6/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
19.5%
8/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
9.8%
4/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Nervous system disorders
Headache
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
14.8%
4/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
16.0%
4/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
6.4%
3/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
14.0%
7/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
9.8%
4/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
12.2%
5/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
20.0%
5/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
10.6%
5/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.0%
2/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.9%
2/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Nervous system disorders
Hypoaesthesia
|
8.3%
1/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.0%
1/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.1%
1/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.0%
1/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.9%
2/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Nervous system disorders
Tremor
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
8.0%
2/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.1%
1/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.0%
1/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.9%
2/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.0%
1/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
10.6%
5/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
12.0%
6/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.9%
2/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.9%
2/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Cardiac disorders
Bradycardia
|
8.3%
1/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.3%
2/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.0%
2/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Vascular disorders
Hypotension
|
8.3%
1/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
12.8%
6/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
12.0%
6/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
3.7%
1/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.1%
1/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.0%
1/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Gastrointestinal disorders
Nausea
|
66.7%
8/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
55.6%
15/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
56.0%
14/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
78.7%
37/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
74.0%
37/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
61.0%
25/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
63.4%
26/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Gastrointestinal disorders
Vomiting
|
33.3%
4/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
22.2%
6/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
28.0%
7/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
36.2%
17/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
38.0%
19/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
34.1%
14/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
39.0%
16/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Gastrointestinal disorders
Constipation
|
16.7%
2/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
14.8%
4/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
8.0%
2/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
14.9%
7/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
14.0%
7/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
14.6%
6/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
19.5%
8/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
8.0%
2/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.9%
2/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
4/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
3.7%
1/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
16.0%
4/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.3%
2/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
8.0%
4/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
17.1%
7/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
12.2%
5/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
8.3%
1/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
22.2%
6/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.0%
1/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
6.4%
3/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.0%
1/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
11.1%
3/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
8.0%
2/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.3%
2/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
8.0%
4/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
9.8%
4/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
14.8%
4/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
8.0%
4/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
7.3%
3/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
3.7%
1/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.0%
1/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
10.6%
5/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
6.0%
3/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.9%
2/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
7.3%
3/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
16.0%
4/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.3%
2/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.9%
2/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
7.4%
2/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.0%
1/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.1%
1/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
General disorders
Medical device site reaction
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
3.7%
1/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
12.0%
3/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
8.5%
4/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
10.0%
5/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
4.9%
2/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
9.8%
4/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
General disorders
Pyrexia
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.1%
1/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
12.0%
6/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/12 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
7.4%
2/27 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/25 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/47 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/50 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
2.4%
1/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (TEAE) are counted only once.
|
0.00%
0/41 • 28 Days.
Subjects reporting more than one Treatment Emergent Adverse Event (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