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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-020471-23 | EudraCT Number |
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The purpose of this study is to characterize the safety of oxycodone hydrochloride (HCl) controlled-release (CR) tablets in opioid tolerant pediatric patients aged 6 to 16 years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxycodone HCl controlled-release | Experimental | Oxycodone hydrochloride (HCl) controlled-release (CR) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxycodone HCl controlled-release tablets | Drug | Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants With Adverse Events as a Measure of Safety. | Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population. | Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment). |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Right Now Assessment by Patients Aged 6 to < 12 Years | Pain right now was assessed by patients aged 6 to <12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with "no hurt" at the far left and "hurts worst" at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment. |
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Inclusion Criteria include:
Exclusion Criteria include:
Other protocol-specific inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States | ||
| University of South Alabama, Children's and Women's Hospital |
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First Patient First Visit: 28-Feb-2011; Last Patient Last Visit: 29-Jul-2014. The study was conducted at medical/research sites in the United States, Spain, United Kingdom, Greece, Guatemala, Hungary, Israel, and New Zealand
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| ID | Title | Description |
|---|---|---|
| FG000 | 6 to < 12 Years | Children 6 to < 12 years of age |
| FG001 | ≥ 12 to ≤ 16 Years | Children ≥ 12 to ≤ 16 years of age |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Baseline to week 4 |
| Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years | Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked "no pain" and the opposite end marked as "pain as bad as it could be." The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the "no pain" end to the patient's mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment. | Baseline to week 4 |
| Use of Supplemental Pain Medication | Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. The dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight. | Baseline to week 4 |
| Parent/ Caregiver-Assessed Global Impression of Change (PGIC) | The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group. | Baseline to week 4 or early discontinuation |
| Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years | The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver. | Baseline to week 4 |
| Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years | The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver. | Baseline to week 4 |
| Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets | A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. Cmax was taken as the maximum simulated oxycodone concentration over the dosing interval and Cmin was the simulated oxycodone concentration when time was equal to 12 hours. Steady-state Cmin and Cmax were derived from the accumulation ratio. The following PK parameters are presented: Cmin / Cmax (minimum / maximum concentration); Cmin,ss / Cmax,ss (Cmin / Cmax at steady state); CAVGss (average concentration at steady state). | Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] |
| Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss | A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. First-dose area under the concentration-time curve (AUC) was derived from the accumulation ratio. For all calculations, the dosing interval was assumed to be 12 hours. The following PK parameters are presented: AUCtau (area under the concentration-time curve from time zero to time equal to dosing interval); AUCss (AUC at steady state). | Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] |
| Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax) | A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. | Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] |
| Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio | A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. The accumulation ratio is used to derive steady-state Cmin and Cmax and first-dose area under the concentration-time curve (AUCtau). | Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] |
| Mobile |
| Alabama |
| 36604 |
| United States |
| Phoenix Children's Hospital | Phoenix | Arizona | 85016 | United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| Children's Hospital of Orange County | Orange | California | 92868 | United States |
| LS Packard Children's Hospital | Palo Alto | California | 94304 | United States |
| Bayview Research Group, LLC | Paramount | California | 90723 | United States |
| Shriners Hospitals for Children Northern California | Sacramento | California | 95817 | United States |
| The Children's Hospital | Aurora | Colorado | 80045 | United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| Alfred I. duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Memorial Regional Hospital | Hollywood | Florida | 33021 | United States |
| Jackson Memorial Hospital/University of Miami | Miami | Florida | 33136 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Children's Memorial Hospital | Chicago | Illinois | 60614 | United States |
| University of Kentucky | Lexington | Kentucky | 40536 | United States |
| Helen DeVos Children's Hospital | Grand Rapids | Michigan | 49503 | United States |
| St. John's Mercy Medical Center | St Louis | Missouri | 63141 | United States |
| New York University Langone Medical Center | New York | New York | 10016 | United States |
| Stony Brook University Hospital | Stony Brook | New York | 11794 | United States |
| Presbyterian Blume Pediatric Hematology and Oncology Clinic | Charlotte | North Carolina | 28204 | United States |
| Duke University Medical Center | Durham | North Carolina | 22710 | United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| Department of Pediatrics, University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| The Children's Hospital at OUMC | Oklahoma City | Oklahoma | 73104 | United States |
| Legacy Emanuel Children's Hospital | Portland | Oregon | 97227 | United States |
| Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania | 15224 | United States |
| Monroe Carell Jr. Children's Hospital at Vanderbilt | Nashville | Tennessee | 37232 | United States |
| Children's Medical Ctr of Dallas | Dallas | Texas | 75235 | United States |
| Research Facility | The Woodlands | Texas | 77381 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113 | United States |
| Children's Hospital of the King's Daughters | Norfolk | Virginia | 23507 | United States |
| Pediatric Hematology and Oncology, Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | United States |
| Children's Hospital of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Agia Sophia Children's Hospital | Athens | 115 27 | Greece |
| Aglaia Kyriakou - Elpida Children's Oncology Unit | Athens | 115 27 | Greece |
| Semmelweis Egyetem, II. sz. Gyermekgyogyaszati Klinika | Budapest | H-1094 | Hungary |
| Soroka University Medical Center | Beersheba | 84101 | Israel |
| Mayer Children Hospital, Rambam Medical Center | Haifa | 31096 | Israel |
| Hadassah Medical Organization, Ein Kerem | Jerusalem | 91120 | Israel |
| Schneider Children Medical Center of Israel | Petah Tikva | 49202 | Israel |
| Sheba Medical Center | Ramat Gan | 52621 | Israel |
| Starship Children's Health | Grafton | Auckland | 1023 | New Zealand |
| Spitalul Clinic Judetean de Urgenta Targu Mures, Clinica pediatrie I | Târgu Mureş | 540136 | Romania |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08025 | Spain |
| Sheffield Children's Hospital | Sheffield | S10 2TH | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety population was the group of patients who received at least 1 dose of study drug during the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 6 to < 12 Years | Children 6 to < 12 years of age |
| BG001 | ≥ 12 to ≤ 16 Years | Children ≥ 12 to ≤ 16 years of age |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Participants With Adverse Events as a Measure of Safety. | Safety assessments consisted of reports of AEs, physical examinations, clinical laboratory test results, vital signs measurements, pulse oximetry (SpO2), and somnolence assessments. Safety variables were summarized descriptively within age group for the safety population. | The safety population was the group of patients who received at least 1 dose of study drug during the study. | Posted | Number | participants | Up to 4 weeks (during the study) and 7-10 days poststudy (safety follow-up assessment). |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pain Right Now Assessment by Patients Aged 6 to < 12 Years | Pain right now was assessed by patients aged 6 to <12 years using the Faces of Pain Scale-Revised (FPS-R). The FPS-R is a horizontal row of 6 faces representing pain intensity, with "no hurt" at the far left and "hurts worst" at the far right; the 6 intensities are scored as 0, 2, 4, 6, 8, or 10 (the patient was not shown the numbers associated with the faces). A score of 0 means no pain, and a 10 means very much pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment. | The safety population was the group of patients who received at least 1 dose of study drug during the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline to week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pain Right Now Assessment by Patients Aged ≥ 12 to ≤ 16 Years | Pain right now was assessed by patients aged ≥ 12 to ≤ 16 years using the 100-mm visual analogue scale (VAS). The 100-mm VAS is a 100-mm line with 1 end marked "no pain" and the opposite end marked as "pain as bad as it could be." The patient was asked to make a mark on that line indicating his or her level of pain. The pain right now 100-mm VAS score was defined as the distance (in mm) from the "no pain" end to the patient's mark. The scale is measured on a 100 mm line: a 0 means no pain and bigger numbers indicate more pain. Pain right now was assessed by the patient at screening; after the first dose; and, thereafter, twice daily during the AM and PM, approximately at the time of each (morning and evening) dose of oxycodone HCl CR tablets during the study treatment. | The safety population was the group of patients who received at least 1 dose of study drug during the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline to week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Use of Supplemental Pain Medication | Supplemental opioid and nonopioid pain medications were permitted during the study as deemed appropriate by the investigator. The dose of supplemental analgesic medication allowed was at the discretion of the investigator and within appropriate dose ranges for age and weight. | The safety population was the group of patients who received at least 1 dose of study drug during the study. | Posted | Number | participants | Baseline to week 4 |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Parent/ Caregiver-Assessed Global Impression of Change (PGIC) | The PGIC rating score variable was collected on a 7-point scale ranging from 1 to 7 (where 1 = very much improved; and 7 = very much worse). The PGIC is designed to assess overall satisfaction with the treatment. The number and percent of parent/caregivers reporting each category of PGIC response at the final visit was summarized for the safety population within age group. | The safety population was the group of patients who received at least 1 dose of study drug during the study. | Posted | Number | participants | Baseline to week 4 or early discontinuation |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged 6 to < 12 Years | The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver. | The safety population was the group of patients who received at least 1 dose of study drug during the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline to week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Parent/ Caregiver Assessed Functional Disability Inventory (FDI) for Patients Aged ≥ 12 to ≤ 16 Years | The FDI is a validated tool used to evaluate the degree to which children have reduced physical and psychosocial functioning because of their pain difficulties in the previous 2 weeks. The FDI comprises 15 items. Responses to each item were scored using a 5-point Likert scale. The individual scores are: (0) no trouble, (1) a little trouble, (2) some trouble, (3) a lot of trouble, and (4) impossible. A total score (ranging from 0 to 60) for the 15 items was calculated, with lower scores indicating less functional disability. The FDI was performed by the parent/ caregiver. | The safety population was the group of patients who received at least 1 dose of study drug during the study. | Posted | Mean | Standard Deviation | units on a scale | Baseline to week 4 |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets | A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. Cmax was taken as the maximum simulated oxycodone concentration over the dosing interval and Cmin was the simulated oxycodone concentration when time was equal to 12 hours. Steady-state Cmin and Cmax were derived from the accumulation ratio. The following PK parameters are presented: Cmin / Cmax (minimum / maximum concentration); Cmin,ss / Cmax,ss (Cmin / Cmax at steady state); CAVGss (average concentration at steady state). | Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration. | Posted | Median | 90% Confidence Interval | ng/mL | Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - AUCtau and AUCss | A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. First-dose area under the concentration-time curve (AUC) was derived from the accumulation ratio. For all calculations, the dosing interval was assumed to be 12 hours. The following PK parameters are presented: AUCtau (area under the concentration-time curve from time zero to time equal to dosing interval); AUCss (AUC at steady state). | Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration. | Posted | Median | 90% Confidence Interval | ng*hour/mL | Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Time to Maximum Concentration (Tmax) | A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. | Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration. | Posted | Median | 90% Confidence Interval | Hours | Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] |
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Pharmacokinetics (PK) Data of Oxycodone Hydrochloride Controlled-release Tablets - Accumulation Ratio | A population PK analysis using sparse plasma concentration data in pediatric patients was conducted. Empirical Bayes estimates were used to calculate individual PK parameters. PK parameters were calculated and reported for each individual patient's first and last dose. The accumulation ratio is used to derive steady-state Cmin and Cmax and first-dose area under the concentration-time curve (AUCtau). | Full analysis population for PK consisted of patients who received at least 1 dose of study drug and had at least 1 valid PK concentration. | Posted | Median | 90% Confidence Interval | Ratio | Day 1 - first dose [2-4 hrs post dose and 4-6 hrs post dose], week 4 - last dose [at pre-dose and at 2-4 hrs post dose] |
|
|
Adverse events (AEs) were reported from start of study participation through the period beyond study completion.
AEs were learned of through spontaneous reports and/or patient interview, or were observed during physical examinations or other safety assessments. Ongoing AEs were followed until resolution or 30 days after last study drug dose. Serious AEs up to 30 days following the last study visit were followed until the AE or sequelae resolved or stabilized.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 6 to < 12 Years | Children 6 to < 12 years of age | 5 | 27 | 13 | 27 | ||
| EG001 | ≥ 12 to ≤ 16 Years | Children ≥ 12 to ≤ 16 years of age | 22 | 128 | 60 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (13.0) | Systematic Assessment | Outcome: Death |
|
| Sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diplopia | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Gastroenteritis clostridial | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Post procedural cellulitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Post procedural complication | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Seroma | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment | Outcome: Death |
|
| Balance disorder | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Coma | Nervous system disorders | MedDRA (13.0) | Systematic Assessment | Outcome: Death. 1 patient (6 to < 12 Years) experienced 3 serious AEs resulting in death: coma, convulsion, and respiratory disorder; 1 patient (≥ 12 to ≤ 16 Years) experienced 2 serious AEs resulting in death: coma and hypoxia. |
|
| Convulsion | Nervous system disorders | MedDRA (13.0) | Systematic Assessment | Outcome: Death. 1 patient (6 to < 12 Years) experienced 3 serious AEs resulting in death: coma, convulsion, and respiratory disorder. |
|
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Lethargy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Status migrainosus | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment | Outcome: death. 1 patient (≥ 12 to ≤ 16 Years) experienced 2 serious AEs resulting in death: coma and hypoxia. |
|
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment | 1 patient (6 to < 12 Years) experienced 3 serious AEs resulting in death: coma, convulsion, and respiratory disorder. |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Axillary vein thrombosis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Leader | Purdue Pharma L.P. | 800-733-1333 |
| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D010098 | Oxycodone |
| ID | Term |
|---|---|
| D003061 | Codeine |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| 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 |
Not provided
Not provided
| Male |
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| Black or African American |
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| Asian |
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| Other |
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