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| ID | Type | Description | Link |
|---|---|---|---|
| FENHYDPAI4012 | |||
| 2008-000529-20 |
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Product class one recall
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The purpose of this study is to evaluate the mobilization characteristics, clinical use, safety and Ease of Care (EOC) of a fentanyl Iontophoretic Transdermal Patient Controlled Analgesia (PCA) system (Ionsys) and morphine intravenous (IV) PCA for management of moderate (medium level of seriousness) to severe (very serious) acute (a quick and severe) pain in participants who have undergone elective major abdominal or orthopedic (pertaining to the bones) surgery.
This is a randomized (study drug assigned by chance), multicentre (when more than one hospital or medical school team work on a medical research study), open-label (participants and physicians are told which treatment the participants are receiving), active-controlled (experimental treatment is compared to a standard treatment), parallel group study (a study comparing the response in two or more groups of participants receiving different treatments). The study will consist of 2 phases: screening phase and an open-label treatment phase. The duration of participation in the study for an individual participant will be 72 hours. Eligible participants (who require pain treatment with strong opioids [morphine like medications] for at least 24 hours after an elective spine or elective orthopedic surgery) will be randomly assigned to receive either Ionsys or morphine IV PCA. Participants' safety will be monitored.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl IONSYS | Experimental | Participants will receive 40 microgram (mcg) of fentanyl dose up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period from an Iontophoretic Transdermal System (IONSYS). |
|
| Morphine IV PCA | Active Comparator | Morphine sulphate solution will be administered intravenously (directly into the vein, IV) by a patient-controlled analgesia (PCA) pump using set bolus (a large amount) doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl IONSYS | Device | Participants will receive 40 mcg of fentanyl dose up to a maximum of 240mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 80 doses within a 24 hour period from an Iontophoretic Transdermal System (IONSYS). |
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Evaluation of Mean Ability to Mobilize After Surgery | The ability to mobilize was assessed through a combined analysis of participant's responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from "not at all" (score 0) to "a very great deal" (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility). | Hour 72 or early study withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Intensity Numerical Rating Scale (NRS) | Pain intensity NRS measured pain intensity experienced by the participant on a scale, 0 to 10, where 0 means no pain and 10 mean the worst possible pain. Participant's pain intensity was assessed by asking following question to the participant: on a scale 0 to 10 where 0 means no pain, and 10 means the worst possible pain, rate the pain that you have now. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Actual Discharge | The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge. | When participant was actually discharged from ward care (assessed up to 258.5 hours) |
| Number of Participants Facing Technical Failure of the Device |
Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Ltd. Clinical Trial | Janssen-Cilag Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belfast | United Kingdom | |||||
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| Label | URL |
|---|---|
| Comparison of Ionsys and routine care with morphine IV PCA in the management of early post-operative mobilisation, ability to mobilise and in time to Fitness For Discharge. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fentanyl IONSYS | Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS [a device which uses an electric current to move drug through the skin into the blood]), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Morphine IV PCA | Device | Morphine sulphate solution will be administered intravenously (IV) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours. |
|
| Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours) |
| Nurse Ease of Care (EOC) Questionnaire Score | Nurse EOC questionnaire had 22 items and covered 3 aspects of care delivery associated with acute care pain management systems: time, bothersome and satisfaction. Items were scored on a 6-point Likert scale, ranging from 'not at all' (Score 0) to 'a very great deal' (score 5). The total score was calculated as the mean of the non-missing items for all the questions. | When participant was fit for discharge (FFD) (assessed up to 91 hours) |
| Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control | The assessment consist of a categorical evaluation (poor, fair, good or excellent) of the method of pain control by asking following question from the participant: "Overall, would you rate this PCA (participant controlled analgesia) method of pain control as being poor, fair, good, or excellent?" | Hour 72 or early study withdrawal |
| Time to Fit For Discharge (FFD) | Participants were assessed for fulfilling the following FFD criteria: 1- Retaining fluids and food; 2- Passing urine without the aid of a catheter; 3- Bowel sounds and/or opening; 4- Cardiovascular stability; 5- Respiratory stability; 6- No post-operative wound complications; 7- Pain adequately controlled with oral analgesia only; 8- Adequately mobile according to locally acceptable standards for mobility for surgery type and pre-operative expectations. The FFD criteria were answered on a "Yes" or "No" basis. When all criteria were answered as Yes, participant was considered to be FFD. | When participant was FFD (assessed up to 91 hours) |
| Number of Participants Who Require Rescue Medication | Rescue medication was defined as a fast-acting medication given besides the study drug that could alleviate pain quickly, but the effects were not long lasting. Morphine was given intravenously as rescue medication for all participants randomly assigned to either treatment group. | Baseline up to Hour 3 |
| Number of Participants Who Require Concomitant Antiemetic Medication | Antiemetic medicines are the drugs which prevent vomiting. | Baseline up to end of study treatment (Hour 72) |
| Number of Participants Who Require Concomitant Non-opioid Analgesics | Non-opioid analgesics are non morphine like medications used to get relieve from pain. | Baseline up to end of study treatment (Hour 72) |
Technical failure was defined as malfunctioning or failure of device to work appropriately. |
| Baseline up to end of study treatment (Hour 72) |
| Cardiff |
| United Kingdom |
| Edinburgh | United Kingdom |
| Glasgow | United Kingdom |
| Liverpool | United Kingdom |
| Salford | United Kingdom |
| Solihull | United Kingdom |
| FG001 | Morphine IV PCA | Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fentanyl IONSYS | Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours. |
| BG001 | Morphine IV PCA | Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Participant's Evaluation of Mean Ability to Mobilize After Surgery | The ability to mobilize was assessed through a combined analysis of participant's responses to the following 3 questions: 1-Because of the system/device, I had to be careful when I used my hands; 2-The system/device made it difficult for me to adjust my position in bed; 3-The system/device interfered with my ability to get out of bed and walk around. All 3 items were scored on a 6-point Likert scale, ranging from "not at all" (score 0) to "a very great deal" (score 5). Total ability to mobilize was assessed as average of 3 scores which range from 0 (best mobility) to 5 (worst mobility). | The intention-to-treat (ITT) population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). | Posted | Mean | Standard Deviation | Units on scale | Hour 72 or early study withdrawal |
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| Secondary | Pain Intensity Numerical Rating Scale (NRS) | Pain intensity NRS measured pain intensity experienced by the participant on a scale, 0 to 10, where 0 means no pain and 10 mean the worst possible pain. Participant's pain intensity was assessed by asking following question to the participant: on a scale 0 to 10 where 0 means no pain, and 10 means the worst possible pain, rate the pain that you have now. | The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'n' signifies those participants evaluable for this measure at the specified time point for each arm group, respectively. | Posted | Mean | Standard Deviation | Unit on Scale | Baseline, Hour 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, study treatment discontinuation or withdrawal, and when participant was fit for discharge (FFD) (assessed up to 91 hours) |
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| Secondary | Nurse Ease of Care (EOC) Questionnaire Score | Nurse EOC questionnaire had 22 items and covered 3 aspects of care delivery associated with acute care pain management systems: time, bothersome and satisfaction. Items were scored on a 6-point Likert scale, ranging from 'not at all' (Score 0) to 'a very great deal' (score 5). The total score was calculated as the mean of the non-missing items for all the questions. | The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). | Posted | Least Squares Mean | 95% Confidence Interval | Units on scale | When participant was fit for discharge (FFD) (assessed up to 91 hours) |
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| Secondary | Number of Participants With Patient Global Assessment (PGA) of Method of Pain Control | The assessment consist of a categorical evaluation (poor, fair, good or excellent) of the method of pain control by asking following question from the participant: "Overall, would you rate this PCA (participant controlled analgesia) method of pain control as being poor, fair, good, or excellent?" | The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). Here 'N' (number of participants analyzed) signifies those participants evaluable for this measure. | Posted | Number | Participants | Hour 72 or early study withdrawal |
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| Secondary | Time to Fit For Discharge (FFD) | Participants were assessed for fulfilling the following FFD criteria: 1- Retaining fluids and food; 2- Passing urine without the aid of a catheter; 3- Bowel sounds and/or opening; 4- Cardiovascular stability; 5- Respiratory stability; 6- No post-operative wound complications; 7- Pain adequately controlled with oral analgesia only; 8- Adequately mobile according to locally acceptable standards for mobility for surgery type and pre-operative expectations. The FFD criteria were answered on a "Yes" or "No" basis. When all criteria were answered as Yes, participant was considered to be FFD. | The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). | Posted | Median | 95% Confidence Interval | Hours | When participant was FFD (assessed up to 91 hours) |
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| Other Pre-specified | Time to Actual Discharge | The time from baseline to the time at which the participant was actually discharged from ward care was recorded as time to actual discharge. | The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). | Posted | Median | 95% Confidence Interval | Hours | When participant was actually discharged from ward care (assessed up to 258.5 hours) |
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| Secondary | Number of Participants Who Require Rescue Medication | Rescue medication was defined as a fast-acting medication given besides the study drug that could alleviate pain quickly, but the effects were not long lasting. Morphine was given intravenously as rescue medication for all participants randomly assigned to either treatment group. | The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). | Posted | Number | Participants | Baseline up to Hour 3 |
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| Secondary | Number of Participants Who Require Concomitant Antiemetic Medication | Antiemetic medicines are the drugs which prevent vomiting. | The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). | Posted | Number | Participants | Baseline up to end of study treatment (Hour 72) |
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| Secondary | Number of Participants Who Require Concomitant Non-opioid Analgesics | Non-opioid analgesics are non morphine like medications used to get relieve from pain. | The ITT population included all participants randomly assigned to study treatment and used the study medication at least once, and who had at least 1 efficacy measure after system application or device enablement (0 hours). | Posted | Number | Participants | Baseline up to end of study treatment (Hour 72) |
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| Other Pre-specified | Number of Participants Facing Technical Failure of the Device | Technical failure was defined as malfunctioning or failure of device to work appropriately. | Safety population included all participants randomly assigned to study treatment and who used either of the study treatment at least once. | Posted | Number | Participants | Baseline up to end of study treatment (Hour 72) |
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From the time a signed informed consent form was obtained until the participant was discharged from ward care
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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 IONSYS | Fentanyl 40 microgram (mcg) per 10 minutes up to a maximum of 240 mcg (6 doses each of 10 minutes duration) per hour but not more than a maximum of 3.2 milligram (80 doses) within 24 hour from an Iontophoretic Transdermal System (IONSYS), applied on the intact, non-irritated skin on the chest or upper arm. Duration of study treatment was 72 hours. | 1 | 58 | 40 | 58 | ||
| EG001 | Morphine IV PCA | Morphine sulphate solution administered intravenously (directly into the vein) by a patient-controlled analgesia (PCA) pump using set bolus doses with a fixed lock out period as per physician's discretion (maximum total dose of 20 milligram per 2 hours) for 72 hours. | 2 | 50 | 38 | 50 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA version 11.0 | Non-systematic Assessment |
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| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Tachycardia | Cardiac disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Abdominal discomfort | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Faeces discoloured | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Reflux gastritis | Gastrointestinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Application site erythema | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Pain | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Application site vesicles | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Catheter Site pain | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Chest discomfort | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Inflammation of wound | General disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
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| Infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA version 11.0 | Non-systematic Assessment |
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| Wound secretion | Injury, poisoning and procedural complications | MedDRA version 11.0 | Non-systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA version 11.0 | Non-systematic Assessment |
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| Bladder injury | Injury, poisoning and procedural complications | MedDRA version 11.0 | Non-systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA version 11.0 | Non-systematic Assessment |
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| Haemoglobin decreased | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
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| Electrocardiogram abnormal | Investigations | MedDRA version 11.0 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Joint effusion | Musculoskeletal and connective tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Syncope vasovagal | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Loss of consciousness | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Hallucination | Psychiatric disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Respiratory depression | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Nasal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Erythema | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Perioperative analgesia | Surgical and medical procedures | MedDRA version 11.0 | Non-systematic Assessment |
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| Spinal anaesthesia | Surgical and medical procedures | MedDRA version 11.0 | Non-systematic Assessment |
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| Hypotension | Vascular disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Haematoma | Vascular disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Orthostatic hypotension | Vascular disorders | MedDRA version 11.0 | Non-systematic Assessment |
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| Wound haemorrhage | Vascular disorders | MedDRA version 11.0 | Non-systematic Assessment |
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Study was temporarily stopped due to an issue with a batch of drug outside the study and later permanently stopped.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Responsible Physician | Janssen-Cilag Ltd. 50-100 Holmers Farm Way, High Wycombe , BUCKS, UK, HP12 4EG | +44 (0) 1494 567 444 |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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