Trial Outcomes & Findings for Phase 2 Bunionectomy HTX-011 Administration Study (NCT NCT03718039)

Last Updated: 2026-03-02

Results Overview

Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are recorded with activity (NRS-A), sitting with the plantar surface of the ball of the surgically attended foot touching the floor (no weight-bearing).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

78 participants

Primary outcome timeframe

72 hours

Results posted on

2026-03-02

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment Group 1: HTX-011 HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.	Treatment Group 2: HTX-011 + Aprepitant HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.	Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.
Overall Study STARTED	30	17	31
Overall Study COMPLETED	30	17	31
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2 Bunionectomy HTX-011 Administration Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment Group 1: HTX-011 n=30 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.	Treatment Group 2: HTX-011 + Aprepitant n=17 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.	Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen n=31 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.	Total n=78 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=41 Participants	16 Participants n=35 Participants	29 Participants n=76 Participants	75 Participants n=565 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants	1 Participants n=35 Participants	2 Participants n=76 Participants	3 Participants n=565 Participants
Age, Continuous	47.3 years STANDARD_DEVIATION 11.58 • n=41 Participants	43.7 years STANDARD_DEVIATION 14.73 • n=35 Participants	49.1 years STANDARD_DEVIATION 12.66 • n=76 Participants	47.2 years STANDARD_DEVIATION 12.74 • n=565 Participants
Sex: Female, Male Female	28 Participants n=41 Participants	13 Participants n=35 Participants	29 Participants n=76 Participants	70 Participants n=565 Participants
Sex: Female, Male Male	2 Participants n=41 Participants	4 Participants n=35 Participants	2 Participants n=76 Participants	8 Participants n=565 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=41 Participants	12 Participants n=35 Participants	15 Participants n=76 Participants	42 Participants n=565 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=41 Participants	5 Participants n=35 Participants	16 Participants n=76 Participants	36 Participants n=565 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants
Race (NIH/OMB) Asian	1 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	1 Participants n=565 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants
Race (NIH/OMB) Black or African American	1 Participants n=41 Participants	1 Participants n=35 Participants	4 Participants n=76 Participants	6 Participants n=565 Participants
Race (NIH/OMB) White	28 Participants n=41 Participants	16 Participants n=35 Participants	27 Participants n=76 Participants	71 Participants n=565 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	0 Participants n=35 Participants	0 Participants n=76 Participants	0 Participants n=565 Participants
Region of Enrollment United States	30 participants n=41 Participants	17 participants n=35 Participants	31 participants n=76 Participants	78 participants n=565 Participants

PRIMARY outcome

Timeframe: 72 hours

Population: Safety Population

Outcome measures

Outcome measures
Measure	Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen n=31 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.	Treatment Group 1: HTX-011 n=30 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.	Treatment Group 2: HTX-011 + Aprepitant n=17 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.
Mean Area Under the Curve (AUC) of the NRS-A (Windowed Worst Observation Carried Forward) Pain Intensity Scores	126.93 pain intensity score*hr Standard Deviation 129.819	278.36 pain intensity score*hr Standard Deviation 151.085	288.23 pain intensity score*hr Standard Deviation 115.790

SECONDARY outcome

Timeframe: 72 hours

Population: Safety Population

Outcome measures

Outcome measures
Measure	Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen n=31 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.	Treatment Group 1: HTX-011 n=30 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.	Treatment Group 2: HTX-011 + Aprepitant n=17 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.
Mean Total Postoperative Opioid Consumption (in Morphine Equivalents) Through 72 Hours	1.61 MME, morphine milligram equivalents Standard Deviation 3.449	11.47 MME, morphine milligram equivalents Standard Deviation 10.198	21.88 MME, morphine milligram equivalents Standard Deviation 13.305

SECONDARY outcome

Timeframe: 72 hours

Population: Safety Population

Outcome measures

Outcome measures
Measure	Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen n=31 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.	Treatment Group 1: HTX-011 n=30 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.	Treatment Group 2: HTX-011 + Aprepitant n=17 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.
Percentage of Subjects Receiving no Opioid Rescue	24 Participants	6 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 7 and Day 28

Population: Safety Population, Cohort 3 only

Only subjects in Cohort 3 received a scheduled, non-opioid MMA regimen following surgery.

Outcome measures

Outcome measures
Measure	Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.	Treatment Group 1: HTX-011 n=31 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.	Treatment Group 2: HTX-011 + Aprepitant HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.
Percentage of Subjects Receiving no Opioid Rescue Day 7	—	24 Participants	—
Percentage of Subjects Receiving no Opioid Rescue Day 28	—	24 Participants	—

SECONDARY outcome

Timeframe: 72 hours

Population: Safety Population

Pain intensity scores are assessed using an 11-point Numeric Rating Scale (NRS) (0-10) where 0 represents "no pain" and 10 represents "worst pain imaginable". NRS scores are measured at rest.

Outcome measures

Outcome measures
Measure	Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen n=31 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.	Treatment Group 1: HTX-011 n=30 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.	Treatment Group 2: HTX-011 + Aprepitant n=17 Participants HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.
Mean Area Under the Curve (AUC) of the NRS-R (Windowed Worst Observation Carried Forward) Pain Intensity Scores	113.10 pain intensity score*hr Standard Deviation 124.696	251.92 pain intensity score*hr Standard Deviation 127.319	252.39 pain intensity score*hr Standard Deviation 112.996

Adverse Events

Treatment Group 1: HTX-011

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Treatment Group 2: HTX-011 + Aprepitant

Serious events: 1 serious events

Other events: 13 other events

Deaths: 0 deaths

Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen

Serious events: 0 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment Group 1: HTX-011 n=30 participants at risk HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.	Treatment Group 2: HTX-011 + Aprepitant n=17 participants at risk HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.	Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen n=31 participants at risk HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.
Infections and infestations Cellulitis	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Infections and infestations Postoperative abscess	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.

Other adverse events

Additional Information

Tricia Mulford

Heron Therapeutics, Inc.

Phone: 760-622-3709

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Treatment Group 1: HTX-011 n=30 participants at risk HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation.	Treatment Group 2: HTX-011 + Aprepitant n=17 participants at risk HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation; Aprepitant, three single doses of aprepitant will be administered orally.	Treatment Group 3: HTX-011 + Non-Opioid MMA Regimen n=31 participants at risk HTX-011 (bupivacaine/meloxicam), up to but not to exceed 60 mg/1.8 mg, via instillation and a scheduled multimodal analgesic (MMA) regimen.
Nervous system disorders Headache	26.7% 8/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	3.2% 1/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Nervous system disorders Dizziness	6.7% 2/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Vascular disorders Hypertension	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	3.2% 1/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Vascular disorders Hypotension	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Infections and infestations Localised infection	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	6.5% 2/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Infections and infestations Tinea pedis	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	3.2% 1/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Infections and infestations Staphylococcal infection	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Metabolism and nutrition disorders Decreased appetite	6.7% 2/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	3.2% 1/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	3.2% 1/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Metabolism and nutrition disorders Hyperlipidaemia	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Nausea	16.7% 5/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	35.3% 6/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	22.6% 7/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Constipation	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	29.4% 5/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	6.5% 2/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Vomiting	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	9.7% 3/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	6.5% 2/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Diarrhoea	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	3.2% 1/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Dyspepsia	3.3% 1/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Ileus	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Gastrointestinal disorders Toothache	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Skin and subcutaneous tissue disorders Hyperhidrosis	3.3% 1/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	3.2% 1/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	11.8% 2/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	3.2% 1/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Skin and subcutaneous tissue disorders Cold sweat	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	6.5% 2/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	6.5% 2/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Reproductive system and breast disorders Menstrual disorder	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Reproductive system and breast disorders Pruritus genital	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
General disorders Pyrexia	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	11.8% 2/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
General disorders Chest discomfort	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
General disorders Feeling hot	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.
Injury, poisoning and procedural complications Post procedural haematoma	0.00% 0/30 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	5.9% 1/17 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.	0.00% 0/31 • 42 Days. For each PT, subjects are included only once, even if they experienced multiple events in that PT.