Trial Outcomes & Findings for Dose-Escalation Study of HTX-034 Following Bunionectomy (NCT NCT04398329)
NCT ID: NCT04398329
Last Updated: 2026-06-09
Results Overview
The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
78 participants
Primary outcome timeframe
42 days
Results posted on
2026-06-09
Participant Flow
The data from Phase 1b and Phase 2 for PD activity and SAEs were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases. Pooling across cohorts was pre-specified in the SAP and was used in analysis of the primary efficacy endpoint, as well as in the sample size calculation.
Participant milestones
| Measure |
Phase 1b: HTX-034 Low Dose
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).
|
Phase 1b: HTX-034 High Dose
Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).
|
Phase 2: HTX-034 Low Dose
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).
|
Phase 2: HTX-034 High Dose
Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).
|
Phases 1b/2: Bupivacaine HCl
Bupivacaine HCl 50 mg. Results were pooled across the entire study.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
12
|
22
|
19
|
|
Overall Study
COMPLETED
|
11
|
13
|
11
|
21
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
1
|
2
|
Reasons for withdrawal
| Measure |
Phase 1b: HTX-034 Low Dose
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).
|
Phase 1b: HTX-034 High Dose
Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).
|
Phase 2: HTX-034 Low Dose
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg (bupivacaine/aprepitant/meloxicam doses).
|
Phase 2: HTX-034 High Dose
Individualized high dose of HTX-034: ranging from 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg (bupivacaine/aprepitant/meloxicam doses).
|
Phases 1b/2: Bupivacaine HCl
Bupivacaine HCl 50 mg. Results were pooled across the entire study.
|
|---|---|---|---|---|---|
|
Overall Study
Ineligible at Day 1
|
1
|
0
|
1
|
1
|
2
|
Baseline Characteristics
Dose-Escalation Study of HTX-034 Following Bunionectomy
Baseline characteristics by cohort
| Measure |
Phase 1b: HTX-034 Low Dose
n=11 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg
|
Phase 1b: HTX-034 High Dose
n=13 Participants
Individualized high dose of HTX-034:30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
Phase 2: HTX-034 Low Dose
n=11 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg
|
Phase 2: HTX-034 High Dose
n=21 Participants
Individualized high dose of HTX-034:30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
Phases 1b/2: Bupivacaine HCl
n=17 Participants
Bupivacaine HCl 50 mg. Results are pooled across the entire study because the dose, surgical procedure, protocol assessments, and participating sites were the same.
|
Total
n=73 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
19 Participants
n=6 Participants
|
17 Participants
n=7 Participants
|
68 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
7 Participants
n=40 Participants
|
16 Participants
n=6 Participants
|
14 Participants
n=7 Participants
|
60 Participants
n=13 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=13 Participants
|
|
Age, Continuous
|
48.6 years
STANDARD_DEVIATION 14.35 • n=20 Participants
|
53.1 years
STANDARD_DEVIATION 12.89 • n=20 Participants
|
51.6 years
STANDARD_DEVIATION 11.25 • n=40 Participants
|
47.0 years
STANDARD_DEVIATION 12.50 • n=6 Participants
|
53.3 years
STANDARD_DEVIATION 6.44 • n=7 Participants
|
50.5 years
STANDARD_DEVIATION 11.57 • n=13 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
19 Participants
n=6 Participants
|
13 Participants
n=7 Participants
|
64 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
3 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=20 Participants
|
13 participants
n=20 Participants
|
11 participants
n=40 Participants
|
21 participants
n=6 Participants
|
17 participants
n=7 Participants
|
73 participants
n=13 Participants
|
PRIMARY outcome
Timeframe: 42 daysPopulation: HTX-034 Phase 1b and Phase 2 low dose and Phase 1b and Phase 2 high dose Arms/Groups and Bupivacaine HCI Arm/Group was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=34 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
n=17 Participants
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=22 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
Incidence of TEAEs in Phases 1b/2
|
23 Participants
|
11 Participants
|
17 Participants
|
—
|
PRIMARY outcome
Timeframe: through 72 hoursMean area under the curve (AUC) of the Numeric Rating Scale (NRS) of pain intensity scores with activity (windowed worst observation carried forward) through 72 hours. The NRS was an 11-point scale (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=34 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
n=17 Participants
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=22 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
AUC0-72 of Pain Scores
|
287.41 pain intensity score*hr
Standard Deviation 144.247
|
363.43 pain intensity score*hr
Standard Deviation 150.177
|
283.50 pain intensity score*hr
Standard Deviation 168.148
|
—
|
SECONDARY outcome
Timeframe: 29 daysPopulation: One Subject did not have PK samples collected before 168 hours postdose due to difficulty in drawing blood from the subject; therefore this subject was excluded from the PK population for 'Phase 2 (Expansion): HTX-034 High Dose' Arm/Group.
Maximum plasma concentration
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=13 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
n=11 Participants
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=11 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
n=20 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
Cmax for HTX-034
Cmax of aprepitant
|
12.0 ng/mL
Standard Deviation 7.44
|
6.37 ng/mL
Standard Deviation 2.23
|
5.12 ng/mL
Standard Deviation 3.64
|
8.09 ng/mL
Standard Deviation 4.36
|
|
Cmax for HTX-034
Cmax of bupivacaine
|
58.7 ng/mL
Standard Deviation 30.6
|
27.4 ng/mL
Standard Deviation 8.37
|
22.0 ng/mL
Standard Deviation 10.1
|
51.2 ng/mL
Standard Deviation 23.9
|
|
Cmax for HTX-034
Cmax of meloxicam
|
29.9 ng/mL
Standard Deviation 17.4
|
18.1 ng/mL
Standard Deviation 8.63
|
11.4 ng/mL
Standard Deviation 7.51
|
27.9 ng/mL
Standard Deviation 13.8
|
SECONDARY outcome
Timeframe: 29 daysPopulation: One Subject did not have PK samples collected before 168 hours postdose due to difficulty in drawing blood from the subject; therefore this subject was excluded from the PK population for 'Phase 2 (Expansion): HTX-034 High Dose' Arm/Group.
Time of maximum plasma concentration
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=13 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
n=11 Participants
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=11 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
n=20 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
Tmax for HTX-034
Tmax of meloxicam
|
18.05 hours (h)
Interval 7.73 to 59.1
|
34.25 hours (h)
Interval 11.77 to 71.7
|
34.35 hours (h)
Interval 8.12 to 70.52
|
21.01 hours (h)
Interval 7.72 to 61.9
|
|
Tmax for HTX-034
Tmax of bupivacaine
|
7.75 hours (h)
Interval 2.03 to 23.83
|
7.73 hours (h)
Interval 4.02 to 18.1
|
4.17 hours (h)
Interval 2.17 to 24.23
|
7.75 hours (h)
Interval 1.98 to 23.42
|
|
Tmax for HTX-034
Tmax of aprepitant
|
58.52 hours (h)
Interval 23.6 to 164.58
|
60.13 hours (h)
Interval 18.13 to 138.17
|
60.20 hours (h)
Interval 17.98 to 120.1
|
58.29 hours (h)
Interval 17.68 to 73.27
|
SECONDARY outcome
Timeframe: 29 daysPopulation: One Subject did not have PK samples collected before 168 hours postdose due to difficulty in drawing blood from the subject; therefore this subject was excluded from the PK population for 'Phase 2 (Expansion): HTX-034 High Dose' Arm/Group.
Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=13 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
n=11 Participants
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=11 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
n=20 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
AUClast for HTX-034
AUClast of bupivacaine
|
1970 h*ng/mL
Standard Deviation 936
|
994 h*ng/mL
Standard Deviation 363
|
795 h*ng/mL
Standard Deviation 510
|
1780 h*ng/mL
Standard Deviation 966
|
|
AUClast for HTX-034
AUClast of aprepitant
|
1330 h*ng/mL
Standard Deviation 813
|
604 h*ng/mL
Standard Deviation 317
|
497 h*ng/mL
Standard Deviation 342
|
910 h*ng/mL
Standard Deviation 696
|
|
AUClast for HTX-034
AUClast of meloxicam
|
2360 h*ng/mL
Standard Deviation 1640
|
1170 h*ng/mL
Standard Deviation 744
|
816 h*ng/mL
Standard Deviation 611
|
1580 h*ng/mL
Standard Deviation 921
|
SECONDARY outcome
Timeframe: 22 daysArea under the concentration-time curve from Time 0 extrapolated to infinity (Phase 1b only)
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=13 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=11 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
AUCinf for HTX-034
AUCinf of bupivacaine
|
2010 h*ng/mL
Standard Deviation 920
|
—
|
835 h*ng/mL
Standard Deviation 509
|
—
|
|
AUCinf for HTX-034
AUCinf of aprepitant
|
1340 h*ng/mL
Standard Deviation 830
|
—
|
702 h*ng/mL
Standard Deviation 306
|
—
|
|
AUCinf for HTX-034
AUCinf of meloxicam
|
2420 h*ng/mL
Standard Deviation 1640
|
—
|
938 h*ng/mL
Standard Deviation 607
|
—
|
SECONDARY outcome
Timeframe: 22 daysApparent terminal half-life of HTX-034 (Phase 1b only)
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=13 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=11 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
t½ of HTX-034
t½ of meloxicam
|
23.2 hours (h)
Standard Deviation 4.87
|
—
|
25.7 hours (h)
Standard Deviation 8.32
|
—
|
|
t½ of HTX-034
t½ of bupivacaine
|
13.9 hours (h)
Standard Deviation 4.99
|
—
|
15.6 hours (h)
Standard Deviation 5.60
|
—
|
|
t½ of HTX-034
t½ of aprepitant
|
42.0 hours (h)
Standard Deviation 24.4
|
—
|
30.6 hours (h)
Standard Deviation 4.63
|
—
|
SECONDARY outcome
Timeframe: 7 daysPopulation: The data from Phase 1b and Phase 2 for PD activity and SAEs were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Mean AUC of the Numeric Rating Scale (NRS) scores with activity (windowed worst observation carried forward). Pain intensity scores were assessed using an 11-point NRS (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=34 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
n=17 Participants
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=22 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
Mean AUC of Pain Scores With Activity
|
561.93 pain intensity score*hr
Standard Deviation 337.621
|
607.31 pain intensity score*hr
Standard Deviation 311.639
|
535.70 pain intensity score*hr
Standard Deviation 322.297
|
—
|
SECONDARY outcome
Timeframe: 7 daysPopulation: The data from Phase 1b and Phase 2 for PD activity and SAEs were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Total postoperative opioid consumption (in IV Morphine Milligram Equivalents). The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=34 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
n=17 Participants
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=22 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
Opioid Consumption
|
10.87 morphine milligram equivalents (MME)
Standard Deviation 17.221
|
8.88 morphine milligram equivalents (MME)
Standard Deviation 7.234
|
9.89 morphine milligram equivalents (MME)
Standard Deviation 12.313
|
—
|
SECONDARY outcome
Timeframe: After surgery (Day 1) through the Day 15 visitPopulation: The data from Phase 1b and Phase 2 for PD activity and SAEs were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Proportion of subjects who took no postoperative opioids through Day 15. The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=34 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
n=17 Participants
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=22 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
Proportion of Subjects Who Are Opioid-free
|
12 Participants
|
4 Participants
|
8 Participants
|
—
|
SECONDARY outcome
Timeframe: 42 daysPopulation: The data from Phase 1b and Phase 2 for PD activity and SAEs were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Number and proportion of subjects with serious adverse events. The data from Phase 1b and Phase 2 were combined for each treatment group because the dose for bupivacaine HCI, HTX-034 low dose and HTX-034 high dose were the same, in both Phases, respectively. In addition, the surgical procedure, protocol assessments, and participating sites were the same in both Phases.
Outcome measures
| Measure |
Phases 1b/2: HTX-034 High Dose
n=34 Participants
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg. Results are pooled across the entire study.
|
Phases 1b/2: Bupivacaine HCl
n=17 Participants
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
Phases 1b/2: HTX-034 Low Dose
n=22 Participants
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. Results are pooled across the entire study.
|
Phase 2: HTX-034 High Dose
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg
|
|---|---|---|---|---|
|
Number of Participants With SAEs
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
Adverse Events
Phase 1b: HTX-034 Low Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 1b: HTX-034 High Dose
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Phase 2: HTX-034 Low Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Phase 2: HTX-034 High Dose
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Phases 1b/2: Bupivacaine HCl
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phase 1b: HTX-034 Low Dose
n=11 participants at risk
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg.
|
Phase 1b: HTX-034 High Dose
n=13 participants at risk
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg.
|
Phase 2: HTX-034 Low Dose
n=11 participants at risk
Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg.
|
Phase 2: HTX-034 High Dose
n=21 participants at risk
Individualized high dose of HTX-034: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg.
|
Phases 1b/2: Bupivacaine HCl
n=17 participants at risk
Bupivacaine HCl 50 mg. Results are pooled across the entire study.
|
|---|---|---|---|---|---|
|
Infections and infestations
Cellulitis
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
4.8%
1/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Psychiatric disorders
Restlessness
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Nervous system disorders
Dizziness
|
27.3%
3/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
23.1%
3/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
18.2%
2/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.5%
2/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
11.8%
2/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Nervous system disorders
Headache
|
18.2%
2/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
23.1%
3/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
4.8%
1/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Nervous system disorders
Somnolence
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
15.4%
2/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
4.8%
1/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
11.8%
2/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Nervous system disorders
Disturbance in attention
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
4.8%
1/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Nervous system disorders
Tremor
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Nervous system disorders
Syncope
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Eye disorders
Visual impairment
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Ear and labyrinth disorders
Tinnitus
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Ear and labyrinth disorders
Tympanic membrane disorder
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
14.3%
3/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.5%
2/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Vascular disorders
Hot flush
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Vascular disorders
Hypertension
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Respiratory, thoracic and mediastinal disorders
Choking
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
38.5%
5/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
27.3%
3/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
4.8%
1/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
23.5%
4/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
27.3%
3/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
14.3%
3/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
17.6%
3/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
23.1%
3/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
27.3%
3/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
4.8%
1/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
4.8%
1/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
15.4%
2/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
11.8%
2/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Impaired healing
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.5%
2/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Fatigue
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
4.8%
1/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Vessel puncture site haematoma
|
18.2%
2/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Chills
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Feeling hot
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Infusion site haematoma
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Injection site swelling
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Oedema peripheral
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Pain
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
General disorders
Vessel puncture site haemorrhage
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Investigations
Blood glucose increased
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Investigations
Blood pressure increased
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
7.7%
1/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Injury, poisoning and procedural complications
Post procedural erythema
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
9.1%
1/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
4.8%
1/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
4.8%
1/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/13 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/11 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
0.00%
0/21 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
5.9%
1/17 • 42 days
Subjects reporting more than one event are counted only once using the highest severity. Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place