Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-01-04 @ 4:49 PM
Study NCT ID:
NCT02287350
Status:
COMPLETED
Last Update Posted:
2017-07-11
First Post:
2014-10-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D059787', 'term': 'Acute Pain'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004008', 'term': 'Diclofenac'}], 'ancestors': [{'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@depomed.com', 'phone': '510-744-8000', 'title': 'Clinical Operations', 'organization': 'Depomed'}, 'certainAgreement': {'otherDetails': 'The PI agrees that sponsor shall have the right to the first publication of the study results which is intended to be a joint, multi-center publication. Following the first publication, the PI may publish study data or results, provided however PI submits the proposed publication to sponsor for review at least 60 days prior to the date of the proposed publication. Sponsor may remove any information that is considered confidential and / or proprietary other than study data.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)', 'description': 'The Safety population included all subjects who have received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain.", 'otherNumAtRisk': 51, 'otherNumAffected': 8, 'seriousNumAtRisk': 51, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 8}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Wound Secretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 51, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Cmax (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '433.9', 'spread': '297.53', 'groupId': 'OG000'}]}]}, {'title': 'pre-dose concentrations (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0000', 'groupId': 'OG000'}]}]}, {'title': '15 min post-dose concentrations (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '378.471', 'spread': '315.3756', 'groupId': 'OG000'}]}]}, {'title': '30 min post-dose concentrations (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '260.484', 'spread': '161.9306', 'groupId': 'OG000'}]}]}, {'title': '60 min post-dose concentrations (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '178.544', 'spread': '108.9297', 'groupId': 'OG000'}]}]}, {'title': '2 hrs post-dose concentrations (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '67.394', 'spread': '54.5705', 'groupId': 'OG000'}]}]}, {'title': '4 hrs post-dose concentrations (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.964', 'spread': '21.4744', 'groupId': 'OG000'}]}]}, {'title': '6 hrs post-dose concentrations (ng/mL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.042', 'spread': '13.0339', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• Cmax: maximum concentration (ng/mL)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.'}, {'type': 'PRIMARY', 'title': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '0.250', 'groupId': 'OG000', 'lowerLimit': '0.22', 'upperLimit': '1.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• Tmax: time to maximum concentration (hr)', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.'}, {'type': 'PRIMARY', 'title': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '0.47329', 'spread': '0.141463', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• λz: elimination rate constant (1/hr)', 'unitOfMeasure': '1/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.'}, {'type': 'PRIMARY', 'title': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '1.692', 'spread': '0.8811', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• t1/2: terminal elimination half-life (hr)', 'unitOfMeasure': 'hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.'}, {'type': 'PRIMARY', 'title': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5 of 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '454.544', 'spread': '219.3114', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr\\*ng/mL)', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.'}, {'type': 'PRIMARY', 'title': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6 of 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '491.915', 'spread': '244.0359', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr\\*ng/mL)', 'unitOfMeasure': 'hr*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.'}, {'type': 'PRIMARY', 'title': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '25927.177', 'spread': '12582.7293', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• CL/F: apparent clearance (mL/hr).', 'unitOfMeasure': 'mL/hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.'}, {'type': 'PRIMARY', 'title': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (8 of 8).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '66845.275', 'spread': '64351.3897', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• Vz/F: apparent volume of distribution (mL).', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects in the Safety population who have at least 1 time point with quantifiable study drug concentration after dosing.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug)', 'description': '• Treatment emergent AEs (TEAEs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)', 'description': '• Serious adverse events (SAEs)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)', 'description': '• Withdrawals due to AEs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)', 'description': '• Deaths', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (degrees C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.94', 'spread': '0.485', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (degrees C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.67', 'spread': '0.492', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (degrees C)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.29', 'spread': '0.511', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in vital sign measurements: Temperature (degrees C).', 'unitOfMeasure': 'degrees C', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (beats/min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '103.7', 'spread': '24.41', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (beats/min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '93.4', 'spread': '16.61', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (beats/min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.5', 'spread': '17.91', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in vital sign measurements: Pulse Rate (beats/min).', 'unitOfMeasure': 'beats/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (breaths/min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.7', 'spread': '3.55', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (breaths/min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.0', 'spread': '2.90', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (breaths/min)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '3.93', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in vital sign measurements: Respiratory Rate (breaths/min).', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '110.8', 'spread': '15.29', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '106.6', 'spread': '13.08', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.5', 'spread': '15.45', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '70.1', 'spread': '12.39', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.1', 'spread': '10.86', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (mmHg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.2', 'spread': '13.81', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last non-missing measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (L/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.357', 'spread': '0.0264', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (L/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.363', 'spread': '0.0290', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (L/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.006', 'spread': '0.0269', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).', 'unitOfMeasure': 'L/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '120.5', 'spread': '10.55', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '121.0', 'spread': '10.69', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '8.20', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '315.2', 'spread': '62.79', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '402.2', 'spread': '109.11', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '85.6', 'spread': '112.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Platelet Count (10\\^9/L).', 'unitOfMeasure': '10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.749', 'spread': '4.7523', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.807', 'spread': '2.2423', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (10^9/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.054', 'spread': '4.7766', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - White Blood Cells (10\\^9/L).', 'unitOfMeasure': '10^9/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (% Basophils)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.414', 'spread': '0.3068', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (% Basophils)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.496', 'spread': '0.3150', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (% Basophils)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.085', 'spread': '0.2466', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Basophils (%).', 'unitOfMeasure': '% Basophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (% Eosinophils)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.911', 'spread': '3.2009', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (% Eosinophils)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.514', 'spread': '3.1678', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit(% Eosinophils)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.532', 'spread': '2.9069', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Eosinophils (%).', 'unitOfMeasure': '% Eosinophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (% Neutrophils)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '49.649', 'spread': '15.1446', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (% Neutrophils)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '48.740', 'spread': '11.1360', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit(% Neutrophils)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.791', 'spread': '17.9732', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Neutrophils (%).', 'unitOfMeasure': '% Neutrophils', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (% Lymphocytes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '37.195', 'spread': '12.4809', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (% Lymphocytes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38.186', 'spread': '10.4428', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit(% Lymphocytes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.866', 'spread': '16.2141', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Lymphocytes (%).', 'unitOfMeasure': '% Lymphocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (% Monocytes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.569', 'spread': '2.9774', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (% Monocytes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.859', 'spread': '2.3952', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (% Monocytes)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.643', 'spread': '3.0825', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Monocytes (%).', 'unitOfMeasure': '% Monocytes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '40.882', 'spread': '4.7314', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '42.341', 'spread': '5.2205', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (g/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.114', 'spread': '3.9131', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Albumin (g/L).', 'unitOfMeasure': 'g/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '219.471', 'spread': '60.3173', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '206.545', 'spread': '54.2160', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.614', 'spread': '29.3505', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '21.569', 'spread': '21.0364', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '17.727', 'spread': '11.5383', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.136', 'spread': '9.0928', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '29.392', 'spread': '11.4001', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.818', 'spread': '5.5793', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.568', 'spread': '11.1426', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '23.590', 'spread': '2.1776', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24.748', 'spread': '2.2748', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.109', 'spread': '2.5307', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.695', 'spread': '2.3525', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.042', 'spread': '2.8647', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.319', 'spread': '3.3429', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.241', 'spread': '1.4054', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.380', 'spread': '1.4918', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.326', 'spread': '1.4264', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '102.959', 'spread': '3.2785', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '101.839', 'spread': '3.1748', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.773', 'spread': '2.7935', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.032', 'spread': '13.0954', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '35.260', 'spread': '12.4928', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (umol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.159', 'spread': '8.3375', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).', 'unitOfMeasure': 'umol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.167', 'spread': '0.7358', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.851', 'spread': '0.9318', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.361', 'spread': '0.9477', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '253.085', 'spread': '75.9762', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '253.071', 'spread': '84.4854', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (U/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.256', 'spread': '100.1911', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - LDH (U/L).', 'unitOfMeasure': 'U/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.366', 'spread': '0.4274', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.337', 'spread': '0.6764', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.038', 'spread': '0.7428', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '138.510', 'spread': '2.7230', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '139.818', 'spread': '2.6787', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (mmol/L)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.409', 'spread': '2.8228', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (pH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.281', 'spread': '0.6214', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (pH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.598', 'spread': '0.8079', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (pH)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.276', 'spread': '0.8720', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Urinalysis - pH.', 'unitOfMeasure': 'pH', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'title': 'Baseline (Specific Gravity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.022', 'spread': '0.0077', 'groupId': 'OG000'}]}]}, {'title': 'Final Visit (Specific Gravity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.020', 'spread': '0.0065', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline to Final Visit (Spec.Gravity)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.000', 'spread': '0.0068', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Urinalysis - Specific Gravity.', 'unitOfMeasure': 'Specific Gravity', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented are changes from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}, {'type': 'SECONDARY', 'title': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Physical examination findings including abnormal clinically significant findings', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety population included all subjects who have received at least 1 dose of study drug.\n\nThe data presented is any new or worsened clinically significant abnormal change from baseline to the final visit. Baseline is defined as the last measurement taken before first treatment with study drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '51', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Diclofenac Potassium Oral Solution', 'description': "5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.\n\ndiclofenac potassium oral solution: Dosing was individualized based on the subject's weight (at least 20 lbs). Volume per dose was 1 mL, 2 mL, 3 mL, 4 mL, or 5 mL; amount of diclofenac potassium per dose was 5 mg, 10 mg, 15 mg, 20 mg, or 25 mg, respectively. Administration of diclofenac potassium oral solution was by mouth, as needed for mild to moderate acute pain."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '6.4', 'spread': '3.10', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-12', 'studyFirstSubmitDate': '2014-10-27', 'resultsFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2014-11-06', 'lastUpdatePostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-06-12', 'studyFirstPostDateStruct': {'date': '2014-11-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-07-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 8).', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• Cmax: maximum concentration (ng/mL)'}, {'measure': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 8).', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• Tmax: time to maximum concentration (hr)'}, {'measure': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 8).', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• λz: elimination rate constant (1/hr)'}, {'measure': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 8).', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• t1/2: terminal elimination half-life (hr)'}, {'measure': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5 of 8).', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• AUC 0-t: area under the concentration-time curve from time 0 to last time point (t) where diclofenac could be measured (hr\\*ng/mL)'}, {'measure': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6 of 8).', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• AUC 0-∞: area under the concentration-time curve from time 0 to infinity (∞) (hr\\*ng/mL)'}, {'measure': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 8).', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• CL/F: apparent clearance (mL/hr).'}, {'measure': 'To Characterize the Pharmacokinetic (PK) Profile of a Single Dose of Diclofenac Potassium Oral Solution, With Weight-based Dosing, in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (8 of 8).', 'timeFrame': '6 hours (pre-dose, 15, 30, and 60 min, and 2, 4, and 6 hrs post-dose)', 'description': '• Vz/F: apparent volume of distribution (mL).'}], 'secondaryOutcomes': [{'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (1 of 7).', 'timeFrame': '4 weeks (first dose of study drug and up to 30 days after the date of the last dose of study drug)', 'description': '• Treatment emergent AEs (TEAEs)'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (2 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)', 'description': '• Serious adverse events (SAEs)'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (3 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)', 'description': '• Withdrawals due to AEs'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (4 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to 30 days after the last dose of study drug)', 'description': '• Deaths'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.1 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in vital sign measurements: Temperature (degrees C).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.2 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in vital sign measurements: Pulse Rate (beats/min).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.3 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in vital sign measurements: Respiratory Rate (breaths/min).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.4 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in vital sign measurements: Systolic Blood Pressure (mmHg).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (5.5 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in vital sign measurements: Diastolic Blood Pressure (mmHg).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.1 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Hematocrit (L/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.2 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Hemoglobin (g/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.3 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Platelet Count (10\\^9/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.4 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - White Blood Cells (10\\^9/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.5 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Basophils (%).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.6 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Eosinophils (%).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.7 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Neutrophils (%).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.8 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Lymphocytes (%).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.9 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Hematology - Monocytes (%).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.10 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Albumin (g/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.11 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Alkaline Phosphatase (U/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.12 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - ALT (SGPT) (U/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.13 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - AST (SGOT) (U/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.14 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Bicarbonate (CO2) (mmol/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.15 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Bilirubin Total (umol/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.16 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - BUN (Urea) (mmol/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.17 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Chloride (mmol/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.18 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Creatinine (umol/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.19 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Glucose (mmol/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.20 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - LDH (U/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.21 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Potassium (mmol/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.22 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Chemistry - Sodium (mmol/L).'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.23 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Urinalysis - pH.'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (6.24 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Changes in clinical laboratory results: Urinalysis - Specific Gravity.'}, {'measure': 'To Determine the Safety and Tolerability of Diclofenac Potassium Oral Solution in Pediatric Subjects, Ages 2-12 Years Experiencing Mild to Moderate Acute Pain (7 of 7).', 'timeFrame': '4 weeks (signed informed consent/assent to the final visit)', 'description': '• Physical examination findings including abnormal clinically significant findings'}]}, 'conditionsModule': {'keywords': ['pain', 'moderate pain', 'mild pain', 'acute pain', 'mild acute pain', 'moderate acute pain', 'mild or moderate acute pain', 'NSAID', 'nonsteroidal anti-inflammatory drug'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'As part of the Pediatric Research Equity Act (PREA) commitment, the objectives of the study are to characterize the pharmacokinetic (PK) profile and to determine the safety and tolerability of diclofenac potassium oral solution in pediatric subjects experiencing mild to moderate acute pain.', 'detailedDescription': 'This is an open-label study with pediatric subjects, ages 2-12 years, who will be dosed with diclofenac potassium oral solution, based on weight, every 6 hours as needed for the treatment of mild to moderate acute pain for up to 4 days. PK samples will be collected through 6 hours after the first dose. Safety data will be collected throughout the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female subjects between 2-12 years of age.\n* Subjects must be post-op, having mild or moderate acute pain.\n\nOther inclusions apply.\n\nExclusion Criteria:\n\n* Subject has a known history of allergic reaction, hypersensitivity to diclofenac, aspirin, acetaminophen, or reaction to the non-active ingredients of the study medication.\n* Subject has been taking analgesics for 48-72 hours prior to Screening.\n* Subject has a history of any GI event greater than 6 months before Screening.\n* Subject is currently receiving any medication that is contraindicated for use concomitantly with diclofenac or acetaminophen.\n* Subject is requiring treatment for pre-existing hypertension.\n\nOther exclusions apply.'}, 'identificationModule': {'nctId': 'NCT02287350', 'briefTitle': 'Pharmacokinetics & Safety of Diclofenac Potassium Oral Solution in Ped. Subjects (2-12 Yrs) With Mild-Mod. Acute Pain', 'organization': {'class': 'INDUSTRY', 'fullName': 'Depomed'}, 'officialTitle': 'A Phase 4, Open-Label Study of the Pharmacokinetics and Safety of Diclofenac Potassium Oral Solution in Pediatric Subjects (Ages 2-12 Years) With Mild to Moderate Acute Pain', 'orgStudyIdInfo': {'id': '81-0074'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'diclofenac potassium oral solution', 'description': '5 mg/mL, liquid form, weight-based dosing, every 6 hours, for up to 4 days.', 'interventionNames': ['Drug: diclofenac potassium oral solution']}], 'interventions': [{'name': 'diclofenac potassium oral solution', 'type': 'DRUG', 'otherNames': ['diclofenac'], 'description': 'Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.', 'armGroupLabels': ['diclofenac potassium oral solution']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sheffield', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.76509, 'lon': -87.69864}}, {'city': 'Stanford', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'city': 'City of Saint Peters', 'state': 'Missouri', 'country': 'United States', 'geoPoint': {'lat': 38.80033, 'lon': -90.62651}}, {'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Depomed', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}