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The purpose of this study is to determine the safety and efficacy of hydromorphone hydrochloride by intrathecal administration using a programmable implantable pump.
A Controlled, Two-Arm, Parallel Group, Randomized Withdrawal Study to Assess the Safety and Efficacy of Hydromorphone Hydrochloride Delivered by Intrathecal Administration Using a Programmable Implantable Pump
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydromorphone Hydrochloride (Randomized/Double-Blind) | Experimental | Subjects on hydromorphone hydrochloride for the duration of therapy. |
|
| Hydromorphone Hydrochloride Titrated Downward/Control (Randomized/Double-Blind) | Active Comparator | Subjects on hydromorphone hydrochloride titrated downward |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydromorphone Hydrochloride | Drug | Opioid for chronic pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Are Treatment Failures During the Double-blind Randomized Withdrawal Period | Treatment failure during the Randomized Phase is defined as at least one of the following: a) increase of >= 20mm VASPI vs. baseline over 5 days; b) intolerable pain that in investigator's opinion requires intervention; or c) pain-related interventions that violate protocol from Day 84 to Day 119. Note: Baseline pain for the randomized phase is defined as the average of the last 5 days with daily pain measurements while on an optimal intrathecal dose of Hydromorphone, between Days 77 and 83 of the open label dosing period. Note: A subject who does not have sufficient data for evaluation, drops out for any other reasons that are not listed above or who experiences withdrawal syndrome as identified by COWS > 12 during the randomized phase will not be classified as a treatment failure. Note: Analysis period is from beginning of randomization phase (Day 84) to end of study. | 5 weeks [Baseline (Day 84) to Day 119 Visit] |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Pain Inventory (BPI): Pain Severity, "Worst" | 'Worst' pain experienced in the past 24 hours. Brief Pain Inventory (BPI): Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome. | 5 Weeks [Baseline (Day 84) to Day 119 Visit] |
| Brief Pain Inventory (BPI): Pain Severity "Average" |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be included:
Exclusion Criteria:
Subjects meeting any of the following criteria will be excluded:
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| Name | Affiliation | Role |
|---|---|---|
| Richard L Rauck, MD | The Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Center for Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hydromorphone Hydrochloride (Randomized/Double-Blind) | Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used. Hydromorphone Hydrochloride: Opioid for chronic pain Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride |
| FG001 | Hydromorphone Titrated Downward/Control (Randomized/Double-Blind) | Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump Hydromorphone Hydrochloride: Opioid for chronic pain Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride |
| FG002 | Not Randomized (Open Label Only) | Enrolled but Not Randomized, dropped out during Open Label phase. Open Label treatment only of their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used. Hydromorphone Hydrochloride: Opioid for chronic pain Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Open Label Phase |
|
| |||||||||||||||||||||
| Randomized Phase |
|
All Enrolled Subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Hydromorphone Hydrochloride (Randomized/Double-Blind) | Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used. Programmable Implantable pump: Programmable Implantable pump delivering intrathecal hydromorphone |
| 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 | Proportion of Subjects Who Are Treatment Failures During the Double-blind Randomized Withdrawal Period | Treatment failure during the Randomized Phase is defined as at least one of the following: a) increase of >= 20mm VASPI vs. baseline over 5 days; b) intolerable pain that in investigator's opinion requires intervention; or c) pain-related interventions that violate protocol from Day 84 to Day 119. Note: Baseline pain for the randomized phase is defined as the average of the last 5 days with daily pain measurements while on an optimal intrathecal dose of Hydromorphone, between Days 77 and 83 of the open label dosing period. Note: A subject who does not have sufficient data for evaluation, drops out for any other reasons that are not listed above or who experiences withdrawal syndrome as identified by COWS > 12 during the randomized phase will not be classified as a treatment failure. Note: Analysis period is from beginning of randomization phase (Day 84) to end of study. | Intent-to-Treat - Randomized Subjects. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group. | Posted | Count of Participants | Participants | 5 weeks [Baseline (Day 84) to Day 119 Visit] |
24 Weeks
Includes all subjects who have study medication loaded into their intrathecal pump (ie, any exposure to hydromorphone hydrochloride).
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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 | Hydromorphone Hydrochloride (Randomized/Double-Blind) | Subjects stay on their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used. Hydromorphone Hydrochloride: Opioid for chronic pain Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heather Kapushoc, Sr. Biostatistician | CTI Clinical Trial and Consulting Services | 571-315-2574 | hkapushoc@ctifacts.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 | Aug 1, 2016 | Apr 9, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 4, 2019 | Apr 18, 2019 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D004091 | Hydromorphone |
| D000701 | Analgesics, Opioid |
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
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|
| Programmable Implantable pump | Device | Programmable Implantable pump delivering intrathecal hydromorphone |
|
'Average' pain experienced in the past 24 hours. The Brief Pain Inventory (BPI): Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome. |
| 5 Weeks [Baseline (Day 84) to Day 119] |
| Brief Pain Inventory (BPI): Pain Severity Summary Measure | Pain severity will be evaluated by rating pain on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) for the 'worst', 'least', and 'average' pain experienced in the past 24 hours, as well as, the pain experienced 'now'. In addition, a calculated mean pain severity score will be based on the sum of all 4 of the pain scores divided by 4. If any of the 4 questions are missing, then the calculated mean pain severity score will be considered missing. High values indicate worse outcome. | 5 Weeks [Baseline (Day 84) to Day 119] |
| Brief Pain Inventory: Interference With Function Summary Measure | Pain interference with daily functioning will be evaluated by rating interference on a scale from 0 (does not interfere) to 10 (completely interferes) for 'general activity', 'mood', 'walking ability', 'normal work', 'relation with other people', 'sleep', and 'enjoyment of life'. A calculated mean pain interference will be based on the sum of non-missing interference questions answered divided by the number of questions answered. The mean should be set to missing if fewer than 4 pain interference questions are answered. A high score is worse. | 5 Weeks [Baseline (Day 84) to Day 119] |
| Short-Form McGill Pain Questionnaire (SF-MPQ): Summary Score | The SF-MPQ consists of a 15 item pain rating index. The severity of each item will be scored as None (0), Mild (1), Moderate (2), or Severe (3). The total SF-MPQ score is the sum of the severity scores for each item. The total score can range from 0 to 45; high score is worse. | 5 Weeks [Baseline (Day 84) to Day 119] |
| Time to Rescue Medication After Randomization (Days) | The number of days to rescue will be calculated by calculating the number of hours between the time of randomization and the time of rescue. The number of hours will then be divided by 24 to obtain the number of days. | 5 Weeks [Baseline (Day 84) to Day 119] |
| Patient Global Impression of Change (PGIC) | The PGIC rating represents observed changes (if any) from the subject's Baseline Visit in activity limitations, symptoms, emotions, and overall quality of life, related to the subject's painful condition. Change is rated on a 7-point Likert-type scale from 1 (no change) through 7 (a great deal better). High score is better outcome. | 5 Weeks [Baseline (Day 84) to Day 119 / Treatment Failure] |
| Oral Opioid Supplement Consumption | Total consumption (mg) = The total number of milligrams consumed of any oral opioid product from Day 84 (Baseline) through the end of study will be calculated for each subject. | 5 Weeks [Baseline (Day 84) to Day 119] |
| Time to Rescue - Rescue Medication Given | Number of subjects with rescue medication given | 5 Weeks [Baseline (Day 84) to Day 119] |
| Non-compliance With Study Drug |
|
| Investigator Decision |
|
| Sponsor Decision |
|
| Protocol Violation |
|
| Changes In The Subject's Condition Render The Subject Unacceptable For Further Treatment |
|
| Inadequate Pain Control |
|
| Other, Specify in text field in database |
|
|
| NOT COMPLETED |
|
|
| BG001 | Hydromorphone Titrated Downward/Control (Randomized/Double-Blind) | Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump |
| BG002 | Not Randomized (Open Label Only) | Enrolled but Not Randomized, dropped out during Open Label phase. Open Label treatment only of their current dose of Hydromorphone Hydrochloride administered via intrathecal (IT) pump; depending on the subject's starting dose on hydromorphone hydrochloride, either a 2 mg/mL or 10 mg/mL formulation may be used. Hydromorphone Hydrochloride: Opioid for chronic pain Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride |
| BG003 | 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 | Number | participants |
|
|
|
|
|
| Secondary | Brief Pain Inventory (BPI): Pain Severity, "Worst" | 'Worst' pain experienced in the past 24 hours. Brief Pain Inventory (BPI): Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome. | Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group. | Posted | Mean | Standard Error | score on a scale | 5 Weeks [Baseline (Day 84) to Day 119 Visit] |
|
|
|
|
| Secondary | Brief Pain Inventory (BPI): Pain Severity "Average" | 'Average' pain experienced in the past 24 hours. The Brief Pain Inventory (BPI): Scale: 0 = No Pain, 10 = Pain as bad as you can imagine; a high score indicates a worse outcome. | Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group. | Posted | Mean | Standard Error | score on a scale | 5 Weeks [Baseline (Day 84) to Day 119] |
|
|
|
|
| Secondary | Brief Pain Inventory (BPI): Pain Severity Summary Measure | Pain severity will be evaluated by rating pain on a scale from 0 (no pain) to 10 (pain as bad as you can imagine) for the 'worst', 'least', and 'average' pain experienced in the past 24 hours, as well as, the pain experienced 'now'. In addition, a calculated mean pain severity score will be based on the sum of all 4 of the pain scores divided by 4. If any of the 4 questions are missing, then the calculated mean pain severity score will be considered missing. High values indicate worse outcome. | Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group. | Posted | Mean | Standard Error | score on scale | 5 Weeks [Baseline (Day 84) to Day 119] |
|
|
|
|
| Secondary | Brief Pain Inventory: Interference With Function Summary Measure | Pain interference with daily functioning will be evaluated by rating interference on a scale from 0 (does not interfere) to 10 (completely interferes) for 'general activity', 'mood', 'walking ability', 'normal work', 'relation with other people', 'sleep', and 'enjoyment of life'. A calculated mean pain interference will be based on the sum of non-missing interference questions answered divided by the number of questions answered. The mean should be set to missing if fewer than 4 pain interference questions are answered. A high score is worse. | Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group. | Posted | Mean | Standard Error | score on scale | 5 Weeks [Baseline (Day 84) to Day 119] |
|
|
|
|
| Secondary | Short-Form McGill Pain Questionnaire (SF-MPQ): Summary Score | The SF-MPQ consists of a 15 item pain rating index. The severity of each item will be scored as None (0), Mild (1), Moderate (2), or Severe (3). The total SF-MPQ score is the sum of the severity scores for each item. The total score can range from 0 to 45; high score is worse. | Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group. | Posted | Mean | Standard Error | score on a scale, summed across 15 quest | 5 Weeks [Baseline (Day 84) to Day 119] |
|
|
|
|
| Secondary | Time to Rescue Medication After Randomization (Days) | The number of days to rescue will be calculated by calculating the number of hours between the time of randomization and the time of rescue. The number of hours will then be divided by 24 to obtain the number of days. | Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group. | Posted | Mean | Standard Deviation | days | 5 Weeks [Baseline (Day 84) to Day 119] |
|
|
|
|
| Secondary | Patient Global Impression of Change (PGIC) | The PGIC rating represents observed changes (if any) from the subject's Baseline Visit in activity limitations, symptoms, emotions, and overall quality of life, related to the subject's painful condition. Change is rated on a 7-point Likert-type scale from 1 (no change) through 7 (a great deal better). High score is better outcome. | Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group. | Posted | Mean | Standard Deviation | score on a scale | 5 Weeks [Baseline (Day 84) to Day 119 / Treatment Failure] |
|
|
|
|
| Secondary | Oral Opioid Supplement Consumption | Total consumption (mg) = The total number of milligrams consumed of any oral opioid product from Day 84 (Baseline) through the end of study will be calculated for each subject. | Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group. | Posted | Mean | Standard Deviation | milligrams (mg) | 5 Weeks [Baseline (Day 84) to Day 119] |
|
|
|
| Secondary | Time to Rescue - Rescue Medication Given | Number of subjects with rescue medication given | Intent-to-Treat - Randomized. Subjects in the Open Label Phase of the study who discontinued the study prior to the Randomization Phase and/or did not meet the criteria for randomization are not included in this analysis as they were not randomized to a treatment group. | Posted | Count of Participants | Participants | 5 Weeks [Baseline (Day 84) to Day 119] |
|
|
|
|
| 0 |
| 41 |
| 2 |
| 41 |
| 35 |
| 41 |
| EG001 | Hydromorphone Titrated Downward/Control (Randomized/Double-Blind) | Subjects have their current dose of Hydromorphone Hydrochloride dose titrated downward; administered via Intrathecal pump Hydromorphone Hydrochloride: Opioid for chronic pain Device: Programmable Implantable pump delivering intrathecal hydromorphone hydrochloride | 0 | 40 | 6 | 40 | 36 | 40 |
| EG002 | Not Randomized (Open Label Only) | Enrolled but not randomized [Entered Open Label Phase includes visits from Day 1 until date of randomization (Day 84)] | 0 | 72 | 9 | 72 | 56 | 72 |
| EG003 | All Subjects | Total serious adverse events from Day 1 through end of study | 0 | 153 | 17 | 153 | 127 | 153 |
| Basal Ganglia Stroke | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Radiculopathy | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Drug Withdrawal Syndrome | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Drug Intolerance | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Non-Cardiac Chest Pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Clostridium Difficile Colitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Implant Site Abscess | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Implant Site Cellulitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Incision Site Infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Craniocerebral Injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Cervical Vertebral Fracture | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Seroma | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Cholecystitis | Hepatobiliary disorders | MedDRA (12.1) | Systematic Assessment |
|
| Angina Unstable | Cardiac disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oesophageal Achalasia | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pain In Extremity | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Sacroiliitis | Musculoskeletal and connective tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Drug Withdrawal Syndrome | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oedema Peripheral | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Chills | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Chest Pain | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (12.1) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Gastrooesophageal Reflux Disease | Gastrointestinal disorders | MedDRA (12.1) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Sciatica | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Lethargy | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA (12.1) | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Gastroenteritis Viral | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (12.1) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (12.1) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (12.1) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Joint Injury | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Thermal Burn | Injury, poisoning and procedural complications | MedDRA (12.1) | Systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA (12.1) | Systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA (12.1) | Systematic Assessment |
|
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006571 |
| Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D009294 | Narcotics |
| D002492 | Central Nervous System Depressants |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D002491 | Central Nervous System Agents |
| D045506 | Therapeutic Uses |
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |