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| ID | Type | Description | Link |
|---|---|---|---|
| JNS020QD-JPN-N03 |
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The purpose of this study is to evaluate the safety and efficacy of fentanyl one-day transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) in participants with chronic (lasting a long time) pain.
This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than one center) and non-comparative study of fentanyl one-day transdermal patch. The study consists of 4 periods: Screening period (3-14 days), Treatment period 1 (4 weeks), Treatment period 2 (48 weeks), Tapering period (0-6 weeks) and Follow-up period (1 week). Treatment will be initiated at 12.5 microgram per hour (mcg/hr). In both Treatment period 1 and 2, the dose will be increased as per the Investigator's discretion, ranging from 12.5 mcg/hr to 100 mcg/hr and the maximum application dose will be 300 mcg/hr. However, in Treatment period 2, the dose will be increased on 7th day before the day of medical examination (only if the participant used rescue treatment for minimum of 3 times per day for minimum of 4 days). The patch will be applied on areas including the chest, abdomen, upper arm and femoral region and replaced daily. Efficacy will primarily be evaluated by visual analog scale (VAS) score. The total duration of the study treatment will be 52 weeks. Participants' safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Experimental | Fentanyl transdermal patch will be applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose will be increased as per Investigators' discretion in both treatment periods and the maximum applied dose will be 300 mcg/hr. Total duration of treatment is 52 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | Fentanyl transdermal patch will be applied daily starting at a dose of 12.5 mcg/hr, and up to 52 weeks. Dose will be increased as per Investigator's discretion. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Questionnaire of Opioid Withdrawal Symptoms | Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (>) 36 points = severe withdrawal. | Week 52 or endpoint (1 week after last treatment or early discontinuation) |
| Dependence Questionnaire (DQ) | The DQ is a clinician rated 5-item scale that evaluates dependence on drug and based on questions (Q). Based on participant's answer to Q in questionnaire, Investigator assessed whether drug dependence occurred. It comprises 5 Q which are: continuing drug for reason other than pain, using drug in more dosage than prescribed to have effect other than treatment of pain, have ever used drug with more dosage than prescribed for other purpose, anxiety with the thought of stopping drug for reason other than aggravation of symptoms by stopping this drug and feeling to violate law to get this drug. | Week 52 or end point (early discontinuation) |
| Pain Visual Analogue Scale Score | Pain visual analog scale was used to assess the amount of pain experienced by the participant throughout the day by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)". | Week 52 or end point (early discontinuation) |
| Number of Participants With Pain Assessed by Categorical Scale for Pain | Pain intensity was measured by assessing the average intensity of pain experienced by the participant in daily living throughout the day by 4 grades: no pain at all, mild (slightly painful, but not worried), moderate (painful, but bearable) and severe (painful and unbearable). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janssen Pharmaceutical K.K.,Japan Clinical Trial | Janssen Pharmaceutical K.K. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amagasaki | Japan | |||||
148 participants were screened, of which 142 participants entered the treatment period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl | Fentanyl transdermal patch (JNS020QD, patch containing a drug that is put on the skin so the drug will enter the body through the skin) was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 (up to 4 Weeks) |
|
| ||||||||||||||||||||||||
| Period 2 (Week 4 to Week 52) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl | Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks. |
| 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 | Questionnaire of Opioid Withdrawal Symptoms | Questionnaire of opioid withdrawal symptoms is a clinician rated 11-item scale that primarily evaluates the physical components of opioid withdrawal and is based on questions and clinical observations. The total score of questionnaire of opioid withdrawal symptoms is the sum of all individual items, with less than (<) 5 points = no withdrawal, 5 to 12 points = mild withdrawal, 13 to 24 points = moderate withdrawal, 25 to 36 points = moderately severe withdrawal and greater than (>) 36 points = severe withdrawal. | Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Number | participants | Week 52 or endpoint (1 week after last treatment or early discontinuation) |
|
Baseline up to 7 days post last dose of study drug
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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 | Fentanyl | Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director, Clinical Research | Janssen Research & Development, L.L.C. USA | 1 609 730-3387 |
Not provided
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
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|
| Week 52 or final evaluation (early discontinuation) |
| Number of Participants With Total Painful Time Per Day | The participants assessed total painful time in 1 day by the following 5 grades: less than 4 hours, 4 hours to less than 8 hours, 8 hours to less than 12 hours, 12 hours or more and all day. | Week 52 or final evaluation (early discontinuation) |
| Number of Participants With Quality of Sleep | The quality of sleep was assessed by participants that how well they have slept from the previous assessment to current assessment time by the following 4 grades: can sleep well, can sleep moderately well, cannot sleep much and cannot sleep at all. | Week 52 or final evaluation (early discontinuation) |
| Number of Rescue Treatments | Rescue treatment was used for participants with lack of analgesic efficacy, to have relief from breakthrough pain and in cases where withdrawal symptoms occur. The reference one-time rescue dose used was oral morphine 5 milligram (mg) for the investigational product fentanyl one-day transdermal patch 12.5 mcg per hr. The number of rescue treatments per day were reported. | Week 52 or final evaluation (early discontinuation) |
| Short-Form 36-Item Health Survey (SF-36) Scores | The SF-36 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. | Week 52 or final evaluation (early discontinuation) |
| Physician's Global Assessment Scale | The treating physician assessed the therapeutic efficacy of the treatment by 2 grades: effective and ineffective. Numbers of participants with effective and ineffective therapeutic efficacy with the treatment were reported. | Week 52 or final evaluation (early discontinuation) |
| Participants Overall Assessment | The participants assessed their satisfaction with therapeutic efficacy by 5 grades: satisfied very much, satisfied, equivocal, dissatisfied and dissatisfied very much. Percentage of participants who were at least satisfied (satisfied, satisfied very much) or at least neither satisfied nor dissatisfied (dissatisfied, dissatisfied very much) were reported. | Week 52 or final evaluation (early discontinuation) |
| Brief Pain Inventory-Short Form (BPI-SF) Total Score | The BPI-SF is a self-report questionnaire designed to assess the severity and impact of pain on daily functions. It includes pain interference score which is mean value for scores for 9 BPI-SF questions ranging between 0 (does not interfere) to 10 (completely interferes) and pain subscale score which is mean value for scores for BPI-SF questions 3 to 6 ranging between 0 (no pain) to 10 (pain as bad as can imagine). Total BPI-SF score is an average of pain interference score and pain subscale score and ranges from 0 to 10; higher score indicates more pain or pain interference. | Week 52 or final evaluation (early discontinuation) |
| Chūō |
| Japan |
| Fukuoka | Japan |
| Hiroshima | Japan |
| Izumo | Japan |
| Kanazawa | Japan |
| Kawasaki | Japan |
| Kitakyushu | Japan |
| Kobe | Japan |
| Kochi | Japan |
| Koga | Japan |
| Maebashi | Japan |
| Matsumoto | Japan |
| Minato | Japan |
| Nishinomiya | Japan |
| Ohmura | Japan |
| Ohta-Ku | Japan |
| Okayama | Japan |
| Saga | Japan |
| Sapporo | Japan |
| Shimotsuga | Japan |
| Suita | Japan |
| Ube | Japan |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Fentanyl transdermal patch was applied once daily up to 4 weeks in Treatment period 1, releasing at the rate of 12.5 microgram per hour (mcg/hr), maintained for 2 days and for another 48 weeks in Treatment period 2. The dose was increased as per Investigators' discretion in both treatment periods and the maximum applied dose was 300 mcg/hr. Total duration of treatment was 52 weeks.
|
|
| Primary | Dependence Questionnaire (DQ) | The DQ is a clinician rated 5-item scale that evaluates dependence on drug and based on questions (Q). Based on participant's answer to Q in questionnaire, Investigator assessed whether drug dependence occurred. It comprises 5 Q which are: continuing drug for reason other than pain, using drug in more dosage than prescribed to have effect other than treatment of pain, have ever used drug with more dosage than prescribed for other purpose, anxiety with the thought of stopping drug for reason other than aggravation of symptoms by stopping this drug and feeling to violate law to get this drug. | Safety population included all the participants who received at least one patch application of the investigational product. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Number | units on a scale | Week 52 or end point (early discontinuation) |
|
|
|
| Primary | Pain Visual Analogue Scale Score | Pain visual analog scale was used to assess the amount of pain experienced by the participant throughout the day by marking a slash through the line of a 100 millimeter (mm) scale measuring pain from "no pain (0 mm)" to "worst possible pain (100 mm)". | Full Analysis Set (FAS) population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. | Posted | Mean | Standard Deviation | mm | Week 52 or end point (early discontinuation) |
|
|
|
| Primary | Number of Participants With Pain Assessed by Categorical Scale for Pain | Pain intensity was measured by assessing the average intensity of pain experienced by the participant in daily living throughout the day by 4 grades: no pain at all, mild (slightly painful, but not worried), moderate (painful, but bearable) and severe (painful and unbearable). | The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Number | participants | Week 52 or final evaluation (early discontinuation) |
|
|
|
| Primary | Number of Participants With Total Painful Time Per Day | The participants assessed total painful time in 1 day by the following 5 grades: less than 4 hours, 4 hours to less than 8 hours, 8 hours to less than 12 hours, 12 hours or more and all day. | The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Number | participants | Week 52 or final evaluation (early discontinuation) |
|
|
|
| Primary | Number of Participants With Quality of Sleep | The quality of sleep was assessed by participants that how well they have slept from the previous assessment to current assessment time by the following 4 grades: can sleep well, can sleep moderately well, cannot sleep much and cannot sleep at all. | The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Number | participants | Week 52 or final evaluation (early discontinuation) |
|
|
|
| Primary | Number of Rescue Treatments | Rescue treatment was used for participants with lack of analgesic efficacy, to have relief from breakthrough pain and in cases where withdrawal symptoms occur. The reference one-time rescue dose used was oral morphine 5 milligram (mg) for the investigational product fentanyl one-day transdermal patch 12.5 mcg per hr. The number of rescue treatments per day were reported. | The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. | Posted | Mean | Standard Deviation | treatments per day | Week 52 or final evaluation (early discontinuation) |
|
|
|
| Primary | Short-Form 36-Item Health Survey (SF-36) Scores | The SF-36 is 36-item form related to 8 health concepts (physical functioning, role physical, role emotional, general health, social functioning, bodily pain, vitality, mental health) and 2 summary scores (physical and mental component summary). Physical functioning, role physical and bodily pain contribute to physical component; role emotional, social functioning and mental health contribute to mental component; and social functioning, vitality, and general health contribute to both. All scores are based on a scale from 0 to 100, with higher scores defining more favorable health state. | The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Week 52 or final evaluation (early discontinuation) |
|
|
|
| Primary | Physician's Global Assessment Scale | The treating physician assessed the therapeutic efficacy of the treatment by 2 grades: effective and ineffective. Numbers of participants with effective and ineffective therapeutic efficacy with the treatment were reported. | The FAS population included all the participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. | Posted | Number | participants | Week 52 or final evaluation (early discontinuation) |
|
|
|
| Primary | Participants Overall Assessment | The participants assessed their satisfaction with therapeutic efficacy by 5 grades: satisfied very much, satisfied, equivocal, dissatisfied and dissatisfied very much. Percentage of participants who were at least satisfied (satisfied, satisfied very much) or at least neither satisfied nor dissatisfied (dissatisfied, dissatisfied very much) were reported. | The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 52 or final evaluation (early discontinuation) |
|
|
|
| Primary | Brief Pain Inventory-Short Form (BPI-SF) Total Score | The BPI-SF is a self-report questionnaire designed to assess the severity and impact of pain on daily functions. It includes pain interference score which is mean value for scores for 9 BPI-SF questions ranging between 0 (does not interfere) to 10 (completely interferes) and pain subscale score which is mean value for scores for BPI-SF questions 3 to 6 ranging between 0 (no pain) to 10 (pain as bad as can imagine). Total BPI-SF score is an average of pain interference score and pain subscale score and ranges from 0 to 10; higher score indicates more pain or pain interference. | The FAS population included all participants with the exception of participants with violation of eligibility criteria, participants with no treatment with the patch of fentanyl and participants without efficacy data after initiation of patch application. Here 'N' (number of participants analyzed) signifies participants evaluable for this measure. | Posted | Mean | Standard Deviation | units on a scale | Week 52 or final evaluation (early discontinuation) |
|
|
|
| 38 |
| 142 |
| 140 |
| 142 |
| Acute tonsillitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pneumonia chlamydial | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pneumonia bacterial | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Benign neoplasm of testis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Bile duct cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Thymoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Completed suicide | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Altered state of consciousness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Mechanical ileus | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hepatitis acute | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Sweat gland disorder | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pharyngitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Acute tonsillitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Cellulitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Folliculitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Impetigo | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Vestibular neuronitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pharyngotonsillitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Arthritis bacterial | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Gastroenteritis bacterial | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Herpes dermatitis | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Urogenital infection fungal | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Oral herpes | Infections and infestations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hyperprolactinaemia | Endocrine disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Delirium | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dissociative disorder | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hallucination | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Extrapyramidal disorder | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Amnesia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Autonomic nervous system imbalance | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Cholinergic syndrome | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Depressed level of consciousness | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Disturbance in attention | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dyskinesia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dyslalia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Parkinsonism | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Stupor | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Tremor | Nervous system disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Cataract | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Conjunctivitis | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Diplopia | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dry eye | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Conjunctival hyperaemia | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Corneal disorder | Eye disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Motion sickness | Ear and labyrinth disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Vertigo positional | Ear and labyrinth disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Bradycardia | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Atrioventricular block first degree | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Cardiac failure congestive | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Palpitations | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Ventricular extrasystoles | Cardiac disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Flushing | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pallor | Vascular disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Stomatitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Gastritis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Periodontitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Haemorrhoids | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Abdominal pain lower | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Anorectal disorder | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Aphthous stomatitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Cheilitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Colonic polyp | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Faecal incontinence | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Gastric ulcer | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Haematemesis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hiatus hernia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Melaena | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Tongue coated | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dyschezia | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Gastrointestinal hypomotility | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Gastrointestinal hypermotility | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Contact stomatitis | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Gastrointestinal sounds abnormal | Gastrointestinal disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Cholelithiasis | Hepatobiliary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pruritus generalised | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Eczema nummular | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Rash generalised | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Skin mass | Skin and subcutaneous tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Myofascial pain syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Joint stiffness | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Periarthritis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Myofascitis | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Limb discomfort | Musculoskeletal and connective tissue disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Urinary retention | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pollakiuria | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Bladder irritation | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Incontinence | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Post streptococcal glomerulonephritis | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Urinary incontinence | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Bladder disorder | Renal and urinary disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Menstruation delayed | Reproductive system and breast disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Application site pruritus | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Thirst | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Malaise | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Drug withdrawal syndrome | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Application site erythema | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Application site dermatitis | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Irritability | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Feeling cold | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Loss of control of legs | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Application site urticaria | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Device failure | General disorders | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Weight decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Blood creatinine increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Blood urea increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Gamma-glutamyltransferase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Liver function test abnormal | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Urobilin urine present | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Blood alkaline phosphatase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Monocyte count increased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Protein total decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Electrocardiogram ST-T segment abnormal | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Protein urine present | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Oxygen saturation decreased | Investigations | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Joint sprain | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Thermal burn | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Epicondylitis | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Postoperative hernia | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Procedural pain | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Post procedural haematuria | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Procedural vomiting | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Heat illness | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
| Procedural nausea | Injury, poisoning and procedural complications | MedDRA Version 13.0 | Non-systematic Assessment |
|
The disclosure restriction on PI is that the Sponsor can review results communications prior to public release and can embargo communications regarding results for a period as the Sponsor requires.
| Title | Measurements |
|---|---|
|
| Q4: Anxious with thought of stopping drug |
|
| Q5: Feeling to violate law to get this drug |
|
| Judgment by doctor: Dependent and abuse |
|
| Judgement by doctor: Not dependent and no abuse |
|
| Title | Measurements |
|---|---|
|
| Severe pain |
|
| Title | Measurements |
|---|---|
|
| 12 hours or more |
|
| All day |
|
| Title | Measurements |
|---|---|
|
| Cannot sleep at all |
|