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This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl. Phase 2 was a dose-expansion phase to evaluate additional subjects treated with the HTX-034 dose selected based on Phase 1b, compared with bupivacaine HCl.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1b: HTX-034 Low Dose | Experimental | 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 | Experimental | 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 | Experimental | 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 | Experimental | 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 1b/2: Bupivacaine HCl | Active Comparator | Bupivacaine HCl (without epinephrine) 0.5%: 50 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HTX-034 low dose | Drug | HTX-034 (bupivacaine/aprepitant/meloxicam) fixed dose: 21.7 mg/4.3 mg/0.6 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of TEAEs in Phases 1b/2 | 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. | 42 days |
| AUC0-72 of Pain Scores | Mean 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. | through 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax for HTX-034 | Maximum plasma concentration | 29 days |
| Tmax for HTX-034 | Time of maximum plasma concentration | 29 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Had contralateral foot bunionectomy in the past 3 months.
Has a planned concurrent surgical procedure.
Has a contraindication or a known or suspected history of hypersensitivity or clinically significant idiosyncratic reaction to required study medications.
Has a pre-existing concurrent acute or chronic painful physical/restrictive condition expected to require analgesic treatment in the postoperative period for pain.
Has received or is taking a contraindicated or prohibited medications.
Received an investigational product or device in a clinical trial within 30 days or within 5 elimination half lives.
Has a known or suspected history of drug abuse, a positive drug screen on the day of surgery, or a recent history of alcohol abuse.
Has a history of clinically significant cardiac abnormality such as myocardial infarction within 6 months.
Has a history of coronary artery bypass graft surgery within 12 months.
Has a history of known or suspected coagulopathy.
As per subject history and/or medical records, has active infection or is currently undergoing treatment for Hepatitis B, Hepatitis C, or human immunodeficiency virus (HIV).
Has uncontrolled anxiety, psychiatric, or neurological disorder.
Had a malignancy in the last year, with the exception of nonmetastatic basal cell or squamous cell carcinoma of the skin or localized carcinoma in situ of the cervix.
Has undergone 3 or more surgeries within 12 months.
Has a known history of glucose-6-phosphate dehydrogenase deficiency.
Has any of the following laboratory abnormalities during Screening (1 retest permitted):
Has a body mass index (BMI) >39 kg/m2.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Research Center | Phoenix | Arizona | 85053 | United States | ||
| First Surgical Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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). |
| FG002 | 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). |
| FG003 | 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). |
| FG004 | Phases 1b/2: Bupivacaine HCl | Bupivacaine HCl 50 mg. Results were pooled across the entire study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1b: HTX-034 Low Dose | Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg |
| BG001 | Phase 1b: 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of TEAEs in Phases 1b/2 | 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. | 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. | Posted | Count of Participants | Participants | 42 days |
|
42 days
Subjects reporting more than one event are counted only once using the highest severity.
Bupivacaine HCI was the same dose, same surgical procedure, same protocol assessments and same sites in Phase 1b and Phase 2, so the Arms are combined given the data provides a larger sample size providing more representative assessment of the 2 doses.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1b: HTX-034 Low Dose | Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis | Infections and infestations | MedDRA, version 23. | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tricia Mulford | Heron Therapeutics, Inc. | 760-622-3709 | tmulford@herontx.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 9, 2021 | Jun 6, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 24, 2021 | Jun 6, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000071378 | Bunion |
| D010149 | Pain, Postoperative |
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D005531 | Foot Deformities, Acquired |
| D005530 | Foot Deformities |
| D009140 | Musculoskeletal Diseases |
| D011183 | Postoperative Complications |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| HTX-034 high dose | Drug | HTX-034 (bupivacaine/aprepitant/meloxicam) individualized dose: 30.6 mg/6.1 mg/0.9 mg to 51.5 mg/10.3 mg/1.5 mg |
|
| Luer lock applicator | Device | Applicator for instillation |
|
| Bupivacaine HCl | Drug | Bupivacaine HCl 50 mg |
|
| AUClast for HTX-034 | Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration | 29 days |
| AUCinf for HTX-034 | Area under the concentration-time curve from Time 0 extrapolated to infinity (Phase 1b only) | 22 days |
| t½ of HTX-034 | Apparent terminal half-life of HTX-034 (Phase 1b only) | 22 days |
| Mean AUC of Pain Scores With Activity | 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. | 7 days |
| Opioid Consumption | 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. | 7 days |
| Proportion of Subjects Who Are Opioid-free | 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. | After surgery (Day 1) through the Day 15 visit |
| Number of Participants With SAEs | 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. | 42 days |
| Bellaire |
| Texas |
| 77401 |
| United States |
| Endeavor Clinical Trials, LLC | San Antonio | Texas | 78229 | United States |
| JBR Clinical Research | Salt Lake City | Utah | 84017 | United States |
| BG002 | Phase 2: HTX-034 Low Dose | Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg |
| BG003 | 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 |
| BG004 | Phases 1b/2: Bupivacaine HCl | Bupivacaine HCl 50 mg. Results are pooled across the entire study because the dose, surgical procedure, protocol assessments, and participating sites were the same. |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Phases 1b/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. Results are pooled across the entire study. |
| OG002 | Phases 1b/2: Bupivacaine HCl | Bupivacaine HCl 50 mg. Results are pooled across the entire study. |
|
|
| Primary | AUC0-72 of Pain Scores | Mean 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. | Posted | Mean | Standard Deviation | pain intensity score*hr | through 72 hours |
|
|
|
| Secondary | Cmax for HTX-034 | Maximum plasma concentration | 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. | Posted | Mean | Standard Deviation | ng/mL | 29 days |
|
|
|
| Secondary | Tmax for HTX-034 | Time of maximum plasma concentration | 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. | Posted | Median | Full Range | hours (h) | 29 days |
|
|
|
| Secondary | AUClast for HTX-034 | Area under the concentration-time curve from Time 0 to the time of the last quantifiable concentration | 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. | Posted | Mean | Standard Deviation | h*ng/mL | 29 days |
|
|
|
| Secondary | AUCinf for HTX-034 | Area under the concentration-time curve from Time 0 extrapolated to infinity (Phase 1b only) | Posted | Mean | Standard Deviation | h*ng/mL | 22 days |
|
|
|
| Secondary | t½ of HTX-034 | Apparent terminal half-life of HTX-034 (Phase 1b only) | Posted | Mean | Standard Deviation | hours (h) | 22 days |
|
|
|
| Secondary | Mean AUC of Pain Scores With Activity | 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. | 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. | Posted | Mean | Standard Deviation | pain intensity score*hr | 7 days |
|
|
|
| Secondary | Opioid Consumption | 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. | 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. | Posted | Mean | Standard Deviation | morphine milligram equivalents (MME) | 7 days |
|
|
|
| Secondary | Proportion of Subjects Who Are Opioid-free | 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. | 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. | Posted | Count of Participants | Participants | After surgery (Day 1) through the Day 15 visit |
|
|
|
| Secondary | Number of Participants With SAEs | 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. | 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. | Posted | Count of Participants | Participants | 42 days |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 8 |
| 11 |
| EG001 | Phase 1b: 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. | 0 | 13 | 0 | 13 | 10 | 13 |
| EG002 | Phase 2: HTX-034 Low Dose | Fixed low dose of HTX-034: 21.7 mg/4.3 mg/0.6 mg. | 0 | 11 | 0 | 11 | 9 | 11 |
| EG003 | 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. | 0 | 21 | 0 | 21 | 13 | 21 |
| EG004 | Phases 1b/2: Bupivacaine HCl | Bupivacaine HCl 50 mg. Results are pooled across the entire study. | 0 | 17 | 0 | 17 | 11 | 17 |
| Dehydration | Metabolism and nutrition disorders | MedDRA, version 23. | Systematic Assessment |
|
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA, version 23. | Systematic Assessment |
|
| Confusional state | Psychiatric disorders | MedDRA, version 23. | Systematic Assessment |
|
| Restlessness | Psychiatric disorders | MedDRA, version 23. | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA, version 23. | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA, version 23. | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA, version 23. | Systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA, version 23. | Systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA, version 23. | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA, version 23. | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA, version 23. | Systematic Assessment |
|
| Sensory loss | Nervous system disorders | MedDRA, version 23. | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA, version 23. | Systematic Assessment |
|
| Lacrimation increased | Eye disorders | MedDRA, version 23. | Systematic Assessment |
|
| Visual impairment | Eye disorders | MedDRA, version 23. | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA, version 23. | Systematic Assessment |
|
| Tympanic membrane disorder | Ear and labyrinth disorders | MedDRA, version 23. | Systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA, version 23. | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA, version 23. | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA, version 23. | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA, version 23. | Systematic Assessment |
|
| Thrombophlebitis superficial | Vascular disorders | MedDRA, version 23. | Systematic Assessment |
|
| Choking | Respiratory, thoracic and mediastinal disorders | MedDRA, version 23. | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA, version 23. | Systematic Assessment |
|
| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA, version 23. | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA, version 23. | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA, version 23. | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA, version 23. | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA, version 23. | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA, version 23. | Systematic Assessment |
|
| Blister | Skin and subcutaneous tissue disorders | MedDRA, version 23. | Systematic Assessment |
|
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA, version 23. | Systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA, version 23. | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA, version 23. | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA, version 23. | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA, version 23. | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA, version 23. | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA, version 23. | Systematic Assessment |
|
| Impaired healing | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Vessel puncture site haematoma | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Chills | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Infusion site haematoma | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Injection site swelling | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Pain | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Vessel puncture site haemorrhage | General disorders | MedDRA, version 23. | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA, version 23. | Systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA, version 23. | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA, version 23. | Systematic Assessment |
|
| Electrocardiogram T wave inversion | Investigations | MedDRA, version 23. | Systematic Assessment |
|
| Hepatic enzyme increased | Investigations | MedDRA, version 23. | Systematic Assessment |
|
| Post procedural erythema | Injury, poisoning and procedural complications | MedDRA, version 23. | Systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA, version 23. | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA, version 23. | Systematic Assessment |
|
Not provided
Not provided
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009422 | Nervous System Diseases |
| D000588 |
| Amines |
| Cmax of aprepitant |
|
| Cmax of meloxicam |
|
| Tmax of aprepitant |
|
| Tmax of meloxicam |
|
| AUClast of aprepitant |
|
| AUClast of meloxicam |
|
| AUCinf of meloxicam |
|
| t½ of meloxicam |
|