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This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, parallel design study evaluating a single dose of one of three CA-008 dose levels vs. placebo injected during an elective bunionectomy Bunionectomy to assess post-surgical pain management and the need for rescue medication (oxycodone).
Primary Objective:
To evaluate the efficacy of a single intraoperative administration of CA- 008 vs placebo in subjects undergoing an elective Bunionectomy .
Secondary Objectives
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CA-008 (vocacapsaicin) 0.7 mg (0.05 mg/mL concentration) | Active Comparator | Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. |
|
| CA-008 (vocacapsaicin) 2.1 mg (0.15 mg/mL concentration) | Active Comparator | Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. |
|
| CA-008 (vocacapsaicin) 4.2 mg (0.3 mg/mL concentration) | Active Comparator | Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. |
|
| Placebo | Placebo Comparator | Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CA-008 | Drug | single-dose wound infiltration prior to surgical incision closure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC) | Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. The time was collected 0 to 96 hours post-dose | [time frame: 96 hours] |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects Opioid Free | Percentage of subjects who are opioid-free for CA-008 compared to placebo. | [time frame: 96 hours] |
| Total Opioid Consumption (in Daily Morphine Equivalents) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Wu | Concentric Analgesics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lotus Clinical Research, LLC | Pasadena | California | 91105 | United States | ||
| Chesapeake Research Group |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | CA-008 0.7 mg (0.05 mg/mL Concentration) | Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| FG001 | CA-008 2.1 mg (0.15 mg/mL Concentration) | Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| FG002 | CA-008 4.2 mg (0.3 mg/mL Concentration) | Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| FG003 | Placebo | Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CA-008 0.7 mg (0.05 mg/mL Concentration) | Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Postsurgical Pain Based on the Weighted Sum of Pain Intensity (SPI) Assessments Over 96 Hours of the NRS Scores = Area Under the Curve (AUC) | Mean area under the curve (AUC) of the Numeric Rating Scale (NRS) weighted sum of pain intensity scores (at rest) from 0-10 where 0 is no pain and 10 is the worst pain imaginable for CA-008 compared to placebo. The time was collected 0 to 96 hours post-dose | Modified Intent to Treat | Posted | Mean | Standard Deviation | scores on a scale*hour | [time frame: 96 hours] |
|
Adverse event data was collected from the time that each participant provided written informed consent (up to 45-day screening period) through Day 36+2 days. The total duration could be a maximum of 83 days.
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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 | CA-008 0.7 mg (0.05 mg/mL Concentration) | Each patient will receive a single dose of 0.7 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cellulitis on left big toe | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | Concentric Analgesics | 14154847921 | nancy@concentricanalgesics.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 6, 2018 | Jun 4, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2018 | Jun 4, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D020910 | Ketorolac |
| D000082 | Acetaminophen |
| D010098 | Oxycodone |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D007213 | Indomethacin |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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|
|
| Placebo | Drug | single-dose wound infiltration prior to surgical incision closure |
|
| Ketorolac | Drug | 30mg IV administered intraoperatively |
|
| Acetaminophen | Drug | 1000mg IV administered intraoperatively |
|
| Oxycodone | Drug | 5mg PO prn post-surgery |
|
| Bupivacaine Hydrochloride | Drug | 0.5% infiltration pre-surgery |
|
Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo
| [time frame: 96 hours] |
| Pasadena |
| Maryland |
| 21122 |
| United States |
| HD Research Corp | Houston | Texas | 77004 | United States |
| Withdrawal by Subject |
|
| Lack of Efficacy |
|
| BG001 | CA-008 2.1 mg (0.15 mg/mL Concentration) | Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| BG002 | CA-008 4.2 mg (0.3 mg/mL Concentration) | Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| BG003 | Placebo | Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | CA-008 2.1 mg (0.15 mg/mL Concentration) | Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| OG002 | CA-008 4.2 mg (0.3 mg/mL Concentration) | Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
| OG003 | Placebo | Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery |
|
|
|
| Secondary | Percentage of Subjects Opioid Free | Percentage of subjects who are opioid-free for CA-008 compared to placebo. | Modified Intent to Treat | Posted | Number | percentage of subjects | [time frame: 96 hours] |
|
|
|
|
| Secondary | Total Opioid Consumption (in Daily Morphine Equivalents) | Mean total postoperative opioid consumption (in daily oral morphine equivalents) for CA-008 compared to placebo | Modified Intent to Treat | Posted | Mean | Standard Deviation | mg morphine equivalents/day | [time frame: 96 hours] |
|
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 27 |
| 36 |
| EG001 | CA-008 2.1 mg (0.15 mg/mL Concentration) | Each patient will receive a single dose of 2.1 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery | 0 | 36 | 0 | 36 | 28 | 36 |
| EG002 | CA-008 4.2 mg (0.3 mg/mL Concentration) | Each patient will receive a single dose of 4.2 mg CA-008 injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. CA-008: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery | 0 | 38 | 0 | 38 | 26 | 38 |
| EG003 | Placebo | Each patient will receive a single dose of CA-008 vehicle (identical to active treatment but without CA-008) injected during an elective Bunionectomy with a multimodal analgesia regimen including a Nonsteroidal anti-inflammatory drug (NSAID) and regional Mayo block with bupivacaine. Placebo: single-dose wound infiltration prior to surgical incision closure Ketorolac: 30mg IV administered intraoperatively Acetaminophen: 1000mg IV administered intraoperatively Oxycodone: 5mg PO prn post-surgery Bupivacaine Hydrochloride: 0.5% infiltration pre-surgery | 0 | 37 | 1 | 37 | 25 | 37 |
| Nausea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Infusion site oedema | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Wound dehiscence | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Burning sensation | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Skin maceration | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Angina pectoris | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Sinus tachycardia | Cardiac disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Eye haematoma | Eye disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Application site pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Administration site warmth | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Application site rash | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Impaired healing | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Infusion site pain | General disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Post procedural cellulitis | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Post procedural infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 21.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Incision site haematoma | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Scar | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 21.0 | Non-systematic Assessment |
|
| Blood glucose increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Body temperature increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA 21.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Muscle twitching | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Hyperaesthesia | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Depressed mood | Psychiatric disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Urge incontinence | Renal and urinary disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Rash erythematous | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Wound drainage | Surgical and medical procedures | MedDRA 21.0 | Non-systematic Assessment |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Diastolic hypotension | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
| Thrombophlebitis | Vascular disorders | MedDRA 21.0 | Non-systematic Assessment |
|
Not provided
Not provided
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006571 | Heterocyclic Compounds |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |