Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2025-12-26 @ 2:24 AM
Study NCT ID:
NCT01116102
Status:
TERMINATED
Last Update Posted:
2011-10-24
First Post:
2010-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)
Sponsor:
Organization:
Raw JSON
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Baxter may request an additional delay of up to 60 days (eg, to allow for intellectual property protection).', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to small numbers of subjects in each treatment arm, no conclusions can be drawn on the influence of any of the individual potential pressure-affecting factors or the combinations of these factors on in-line fluid pressure.'}}, 'adverseEventsModule': {'timeFrame': '7 days', 'eventGroups': [{'id': 'EG000', 'title': '24 ga Catheter, Dose Flush, Single-step Rate Scheme', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '24 ga Catheter, No Dose Flush, Single-step Rate Scheme', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '24 ga Catheter, Dose Flush, Up-titrated Rate Scheme', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': '25 ga Needle, Dose Flush, Single-step Rate Scheme', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': '25 ga Needle, No Dose Flush, Single-step Rate Scheme', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': '25 ga Needle, Dose Flush, Up-titrated Rate Scheme', 'otherNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': '25 ga Needle, No Dose Flush, Up-titrated Rate Scheme', 'otherNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Infusion site erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Infusion site oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Infusion site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Infusion site pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Infusion site rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Infusion site swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 2, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (13.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Measured In-line Fluid Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '24 ga Catheter, Dose Flush, Single-step Rate Scheme'}, {'id': 'OG001', 'title': '24 ga Catheter, No Dose Flush, Single-step Rate Scheme'}, {'id': 'OG002', 'title': '24 ga Catheter, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG003', 'title': '24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG004', 'title': '25 ga Needle, Dose Flush, Single-step Rate Scheme'}, {'id': 'OG005', 'title': '25 ga Needle, No Dose Flush, Single-step Rate Scheme'}, {'id': 'OG006', 'title': '25 ga Needle, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG007', 'title': '25 ga Needle, No Dose Flush, Up-titrated Rate Scheme'}], 'classes': [{'title': '1 min', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '11.1'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '3.5'}, {'value': '6.8', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '10.6'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '11.7'}, {'value': '3.8', 'groupId': 'OG004', 'lowerLimit': '3.7', 'upperLimit': '3.8'}, {'value': '2.8', 'groupId': 'OG005', 'lowerLimit': '2.8', 'upperLimit': '2.8'}, {'value': '1.1', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '1.2'}, {'value': '3.0', 'groupId': 'OG007', 'lowerLimit': '1.5', 'upperLimit': '5.1'}]}]}, {'title': '2 min', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '10.8'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '2.7'}, {'value': '7.8', 'groupId': 'OG002', 'lowerLimit': '3.3', 'upperLimit': '12.3'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '14.2'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '3.8', 'upperLimit': '4.4'}, {'value': '3.1', 'groupId': 'OG005', 'lowerLimit': '3.1', 'upperLimit': '3.1'}, {'value': '1.1', 'groupId': 'OG006', 'lowerLimit': '0.9', 'upperLimit': '1.4'}, {'value': '2.4', 'groupId': 'OG007', 'lowerLimit': '1.1', 'upperLimit': '4.7'}]}]}, {'title': '3 min', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '10.6'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '2.5'}, {'value': '7.4', 'groupId': 'OG002', 'lowerLimit': '3.5', 'upperLimit': '11.2'}, {'value': '6.1', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '14.9'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '4.4'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '1.2', 'groupId': 'OG006', 'lowerLimit': '1.1', 'upperLimit': '1.3'}, {'value': '2.5', 'groupId': 'OG007', 'lowerLimit': '1.0', 'upperLimit': '4.9'}]}]}, {'title': '4 min', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '10.4'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.5'}, {'value': '7.3', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '11.0'}, {'value': '6.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '15.9'}, {'value': '4.3', 'groupId': 'OG004', 'lowerLimit': '4.3', 'upperLimit': '4.3'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '1.0', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '1.1'}, {'value': '2.8', 'groupId': 'OG007', 'lowerLimit': '1.6', 'upperLimit': '4.7'}]}]}, {'title': '5 min', 'categories': [{'measurements': [{'value': '6.1', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '9.5'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.1'}, {'value': '9.1', 'groupId': 'OG002', 'lowerLimit': '7.7', 'upperLimit': '10.6'}, {'value': '5.7', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '15.1'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '4.3', 'upperLimit': '4.4'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '1.1', 'groupId': 'OG006', 'lowerLimit': '1.1', 'upperLimit': '1.1'}, {'value': '2.5', 'groupId': 'OG007', 'lowerLimit': '1.1', 'upperLimit': '4.9'}]}]}, {'title': '6 min', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '9.6'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '6.0'}, {'value': '8.0', 'groupId': 'OG002', 'lowerLimit': '4.9', 'upperLimit': '11.1'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '1.4', 'upperLimit': '18.4'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '4.2'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '2.2', 'groupId': 'OG006', 'lowerLimit': '2.1', 'upperLimit': '2.2'}, {'value': '2.4', 'groupId': 'OG007', 'lowerLimit': '2.2', 'upperLimit': '2.5'}]}]}, {'title': '7 min', 'categories': [{'measurements': [{'value': '6.2', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '9.7'}, {'value': '3.2', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '5.7'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '3.4', 'upperLimit': '14.1'}, {'value': '7.1', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '17.8'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '4.2'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '2.1', 'groupId': 'OG006', 'lowerLimit': '2.1', 'upperLimit': '2.2'}, {'value': '3.8', 'groupId': 'OG007', 'lowerLimit': '2.2', 'upperLimit': '6.9'}]}]}, {'title': '8 min', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '10.1'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '5.9'}, {'value': '9.0', 'groupId': 'OG002', 'lowerLimit': '3.7', 'upperLimit': '14.4'}, {'value': '7.3', 'groupId': 'OG003', 'lowerLimit': '2.8', 'upperLimit': '16.1'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '4.3'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '2.1', 'groupId': 'OG006', 'lowerLimit': '2.1', 'upperLimit': '2.2'}, {'value': '4.6', 'groupId': 'OG007', 'lowerLimit': '2.1', 'upperLimit': '7.6'}]}]}, {'title': '9 min', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '10.2'}, {'value': '3.8', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.8'}, {'value': '8.2', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '13.5'}, {'value': '7.0', 'groupId': 'OG003', 'lowerLimit': '2.5', 'upperLimit': '14.5'}, {'value': '4.2', 'groupId': 'OG004', 'lowerLimit': '4.2', 'upperLimit': '4.2'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '2.2', 'groupId': 'OG006', 'lowerLimit': '2.1', 'upperLimit': '2.3'}, {'value': '4.1', 'groupId': 'OG007', 'lowerLimit': '2.1', 'upperLimit': '7.9'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '10.2'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '6.7'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '2.9', 'upperLimit': '12.5'}, {'value': '6.2', 'groupId': 'OG003', 'lowerLimit': '2.4', 'upperLimit': '12.6'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '4.2'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '2.2', 'groupId': 'OG006', 'lowerLimit': '2.1', 'upperLimit': '2.3'}, {'value': '3.9', 'groupId': 'OG007', 'lowerLimit': '2.1', 'upperLimit': '7.4'}]}]}, {'title': '11 min', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '10.3'}, {'value': '3.7', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '6.5'}, {'value': '11.9', 'groupId': 'OG002', 'lowerLimit': '5.5', 'upperLimit': '18.2'}, {'value': '7.6', 'groupId': 'OG003', 'lowerLimit': '2.7', 'upperLimit': '14.5'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '4.2'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '4.0', 'groupId': 'OG006', 'lowerLimit': '3.9', 'upperLimit': '4.0'}, {'value': '6.4', 'groupId': 'OG007', 'lowerLimit': '2.1', 'upperLimit': '12.8'}]}]}, {'title': '12 min', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '10.6'}, {'value': '4.2', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '8.9'}, {'value': '13.6', 'groupId': 'OG002', 'lowerLimit': '4.3', 'upperLimit': '22.9'}, {'value': '10.3', 'groupId': 'OG003', 'lowerLimit': '2.2', 'upperLimit': '21.2'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '4.2'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '3.8', 'groupId': 'OG006', 'lowerLimit': '3.7', 'upperLimit': '3.9'}, {'value': '7.4', 'groupId': 'OG007', 'lowerLimit': '2.1', 'upperLimit': '13.0'}]}]}, {'title': '13 min', 'categories': [{'measurements': [{'value': '6.7', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '10.7'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '7.2'}, {'value': '7.7', 'groupId': 'OG002', 'lowerLimit': '3.1', 'upperLimit': '12.2'}, {'value': '10.5', 'groupId': 'OG003', 'lowerLimit': '2.3', 'upperLimit': '18.8'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '4.2'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '3.9', 'groupId': 'OG006', 'lowerLimit': '3.8', 'upperLimit': '4.0'}, {'value': '7.0', 'groupId': 'OG007', 'lowerLimit': '3.8', 'upperLimit': '12.8'}]}]}, {'title': '14 min', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '10.5'}, {'value': '3.0', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '5.2'}, {'value': '3.5', 'groupId': 'OG002', 'lowerLimit': '2.6', 'upperLimit': '4.4'}, {'value': '17.7', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '34.2'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '4.2'}, {'value': '3.3', 'groupId': 'OG005', 'lowerLimit': '3.3', 'upperLimit': '3.3'}, {'value': '3.6', 'groupId': 'OG006', 'lowerLimit': '3.4', 'upperLimit': '3.9'}, {'value': '6.9', 'groupId': 'OG007', 'lowerLimit': '3.8', 'upperLimit': '11.4'}]}]}, {'title': '15 min', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '3.5', 'upperLimit': '11.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '5.8'}, {'value': '3.4', 'groupId': 'OG002', 'lowerLimit': '2.6', 'upperLimit': '4.2'}, {'value': '15.8', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '34.1'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '4.2'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '3.7', 'groupId': 'OG006', 'lowerLimit': '3.5', 'upperLimit': '3.9'}, {'value': '6.5', 'groupId': 'OG007', 'lowerLimit': '3.8', 'upperLimit': '11.8'}]}]}, {'title': '20 min', 'categories': [{'measurements': [{'value': '7.3', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '11.5'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '3.0'}, {'value': '3.3', 'groupId': 'OG002', 'lowerLimit': '2.7', 'upperLimit': '3.9'}, {'value': '11.9', 'groupId': 'OG003', 'lowerLimit': '1.8', 'upperLimit': '26.3'}, {'value': '4.1', 'groupId': 'OG004', 'lowerLimit': '4.0', 'upperLimit': '4.3'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '3.6', 'groupId': 'OG006', 'lowerLimit': '3.5', 'upperLimit': '3.7'}, {'value': '6.2', 'groupId': 'OG007', 'lowerLimit': '3.8', 'upperLimit': '10.9'}]}]}, {'title': '25 min', 'categories': [{'measurements': [{'value': '6.8', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '10.4'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '2.9'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '4.1'}, {'value': '8.7', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '21.3'}, {'value': '4.8', 'groupId': 'OG004', 'lowerLimit': '4.3', 'upperLimit': '5.4'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '3.7', 'groupId': 'OG006', 'lowerLimit': '3.7', 'upperLimit': '3.8'}, {'value': '6.1', 'groupId': 'OG007', 'lowerLimit': '3.6', 'upperLimit': '10.1'}]}]}, {'title': '30 min', 'categories': [{'measurements': [{'value': '5.8', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '8.3'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.8'}, {'value': '8.4', 'groupId': 'OG002', 'lowerLimit': '2.1', 'upperLimit': '14.8'}, {'value': '8.6', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '21.2'}, {'value': '4.8', 'groupId': 'OG004', 'lowerLimit': '4.8', 'upperLimit': '4.9'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '3.8', 'groupId': 'OG006', 'lowerLimit': '3.5', 'upperLimit': '4.0'}, {'value': '5.8', 'groupId': 'OG007', 'lowerLimit': '3.6', 'upperLimit': '9.8'}]}]}, {'title': '35 min', 'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000', 'lowerLimit': '3.3', 'upperLimit': '9.8'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '4.0'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '3.9'}, {'value': '10.9', 'groupId': 'OG003', 'lowerLimit': '2.3', 'upperLimit': '19.5'}, {'value': '4.5', 'groupId': 'OG004', 'lowerLimit': '4.5', 'upperLimit': '4.5'}, {'value': '3.3', 'groupId': 'OG005', 'lowerLimit': '3.3', 'upperLimit': '3.3'}, {'value': '4.2', 'groupId': 'OG006', 'lowerLimit': '3.4', 'upperLimit': '5.1'}, {'value': '6.4', 'groupId': 'OG007', 'lowerLimit': '3.6', 'upperLimit': '12.0'}]}]}, {'title': '40 min', 'categories': [{'measurements': [{'value': '7.0', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '10.9'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '2.3'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '3.8'}, {'value': '11.5', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '20.8'}, {'value': '4.6', 'groupId': 'OG004', 'lowerLimit': '4.5', 'upperLimit': '4.6'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '3.4', 'groupId': 'OG006', 'lowerLimit': '3.4', 'upperLimit': '3.4'}, {'value': '5.9', 'groupId': 'OG007', 'lowerLimit': '3.6', 'upperLimit': '10.6'}]}]}, {'title': '45 min', 'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '10.4'}, {'value': '2.3', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '2.6'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '3.9'}, {'value': '7.4', 'groupId': 'OG003', 'lowerLimit': '1.7', 'upperLimit': '18.6'}, {'value': '4.3', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '4.6'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '3.4', 'groupId': 'OG006', 'lowerLimit': '3.3', 'upperLimit': '3.5'}, {'value': '5.8', 'groupId': 'OG007', 'lowerLimit': '3.6', 'upperLimit': '10.0'}]}]}, {'title': '50 min', 'categories': [{'measurements': [{'value': '6.4', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '10.0'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.6'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '4.1'}, {'value': '7.8', 'groupId': 'OG003', 'lowerLimit': '1.6', 'upperLimit': '19.8'}, {'value': '4.5', 'groupId': 'OG004', 'lowerLimit': '4.5', 'upperLimit': '4.5'}, {'value': '3.3', 'groupId': 'OG005', 'lowerLimit': '3.3', 'upperLimit': '3.3'}, {'value': '3.4', 'groupId': 'OG006', 'lowerLimit': '3.3', 'upperLimit': '3.5'}, {'value': '5.8', 'groupId': 'OG007', 'lowerLimit': '3.5', 'upperLimit': '10.1'}]}]}, {'title': '55 min', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '7.9'}, {'value': '2.4', 'groupId': 'OG001', 'lowerLimit': '2.2', 'upperLimit': '2.6'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '3.8'}, {'value': '7.9', 'groupId': 'OG003', 'lowerLimit': '2.1', 'upperLimit': '19.0'}, {'value': '4.4', 'groupId': 'OG004', 'lowerLimit': '4.3', 'upperLimit': '4.5'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '3.4', 'groupId': 'OG006', 'lowerLimit': '3.2', 'upperLimit': '3.5'}, {'value': '6.0', 'groupId': 'OG007', 'lowerLimit': '3.5', 'upperLimit': '10.9'}]}]}, {'title': '60 min', 'categories': [{'measurements': [{'value': '5.3', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '7.7'}, {'value': '3.1', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '4.3'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '2.0', 'upperLimit': '3.8'}, {'value': '7.7', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '19.3'}, {'value': '3.7', 'groupId': 'OG004', 'lowerLimit': '3.6', 'upperLimit': '3.8'}, {'value': '3.2', 'groupId': 'OG005', 'lowerLimit': '3.2', 'upperLimit': '3.2'}, {'value': '3.4', 'groupId': 'OG006', 'lowerLimit': '3.3', 'upperLimit': '3.4'}, {'value': '6.5', 'groupId': 'OG007', 'lowerLimit': '3.5', 'upperLimit': '12.2'}]}]}, {'title': '75 min', 'categories': [{'measurements': [{'value': '4.6', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '6.7'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '3.2'}, {'value': '2.3', 'groupId': 'OG002', 'lowerLimit': '1.8', 'upperLimit': '2.8'}, {'value': '5.9', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '14.2'}, {'value': '3.6', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': '4.1'}, {'value': '2.8', 'groupId': 'OG005', 'lowerLimit': '2.8', 'upperLimit': '2.8'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.6', 'upperLimit': '2.7'}, {'value': '7.8', 'groupId': 'OG007', 'lowerLimit': '2.8', 'upperLimit': '16.1'}]}]}, {'title': '90 min', 'categories': [{'measurements': [{'value': '4.1', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '5.3'}, {'value': '3.6', 'groupId': 'OG001', 'lowerLimit': '2.4', 'upperLimit': '4.5'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1.6', 'upperLimit': '2.7'}, {'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '1.3', 'upperLimit': '8.9'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': '4.0'}, {'value': '2.7', 'groupId': 'OG005', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.7', 'groupId': 'OG006', 'lowerLimit': '2.6', 'upperLimit': '2.8'}, {'value': '7.5', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '16.7'}]}]}, {'title': '105 min', 'categories': [{'measurements': [{'value': '5.0', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '7.1'}, {'value': '2.7', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.2'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '1.7', 'upperLimit': '2.7'}, {'value': '4.5', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '10.5'}, {'value': '4.0', 'groupId': 'OG004', 'lowerLimit': '3.1', 'upperLimit': '4.9'}, {'value': '2.7', 'groupId': 'OG005', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.6', 'upperLimit': '2.6'}, {'value': '6.3', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '13.0'}]}]}, {'title': '120 min', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '4.1'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '1.9', 'upperLimit': '3.6'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '3.4'}, {'value': '5.2', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '12.6'}, {'value': '4.3', 'groupId': 'OG004', 'lowerLimit': '3.5', 'upperLimit': '5.1'}, {'value': '2.9', 'groupId': 'OG005', 'lowerLimit': '2.9', 'upperLimit': '2.9'}, {'value': '2.8', 'groupId': 'OG006', 'lowerLimit': '2.6', 'upperLimit': '3.0'}, {'value': '6.8', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '14.3'}]}]}, {'title': '135 min', 'categories': [{'measurements': [{'value': '4.0', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '4.9'}, {'value': '2.2', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '2.3'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '2.9'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '12.1'}, {'value': '3.8', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '4.7'}, {'value': '2.7', 'groupId': 'OG005', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.6', 'upperLimit': '2.7'}, {'value': '7.4', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '16.5'}]}]}, {'title': '150 min', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '3.0'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '2.3', 'upperLimit': '18.4'}, {'value': '2.0', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '2.6'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '12.2'}, {'value': '3.7', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '4.4'}, {'value': '2.6', 'groupId': 'OG005', 'lowerLimit': '2.6', 'upperLimit': '2.6'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '2.7'}, {'value': '7.0', 'groupId': 'OG007', 'lowerLimit': '2.8', 'upperLimit': '13.4'}]}]}, {'title': '165 min', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.7', 'upperLimit': '3.4'}, {'value': '2.6', 'groupId': 'OG001', 'lowerLimit': '2.1', 'upperLimit': '3.7'}, {'value': '2.6', 'groupId': 'OG002', 'lowerLimit': '2.4', 'upperLimit': '2.8'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '12.0'}, {'value': '4.6', 'groupId': 'OG004', 'lowerLimit': '4.1', 'upperLimit': '5.1'}, {'value': '2.6', 'groupId': 'OG005', 'lowerLimit': '2.6', 'upperLimit': '2.6'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '2.6'}, {'value': '3.4', 'groupId': 'OG007', 'lowerLimit': '2.6', 'upperLimit': '4.1'}]}]}, {'title': '180 min', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.9', 'upperLimit': '3.4'}, {'value': '2.1', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '2.4'}, {'value': '2.1', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '2.7'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '11.5'}, {'value': '3.3', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '3.9'}, {'value': '2.6', 'groupId': 'OG005', 'lowerLimit': '2.6', 'upperLimit': '2.6'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '2.6'}, {'value': '3.2', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '3.5'}]}]}, {'title': '195 min', 'categories': [{'measurements': [{'value': '3.8', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '4.6'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '8.3'}, {'value': '2.5', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '3.4'}, {'value': '5.2', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '12.8'}, {'value': '3.8', 'groupId': 'OG004', 'lowerLimit': '3.1', 'upperLimit': '4.4'}, {'value': '2.6', 'groupId': 'OG005', 'lowerLimit': '2.6', 'upperLimit': '2.6'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '2.8'}, {'value': '3.4', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '4.5'}]}]}, {'title': '210 min', 'categories': [{'measurements': [{'value': '3.6', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '4.2'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.8', 'upperLimit': '7.0'}, {'value': '2.2', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '2.4'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '11.7'}, {'value': '3.9', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '4.9'}, {'value': '2.8', 'groupId': 'OG005', 'lowerLimit': '2.8', 'upperLimit': '2.8'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '2.7'}, {'value': '6.3', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '8.6'}]}]}, {'title': '225 min', 'categories': [{'measurements': [{'value': '3.4', 'groupId': 'OG000', 'lowerLimit': '3.1', 'upperLimit': '3.6'}, {'value': '4.3', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '9.1'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '1.5', 'upperLimit': '2.3'}, {'value': '4.9', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '12.0'}, {'value': '3.1', 'groupId': 'OG004', 'lowerLimit': '2.9', 'upperLimit': '3.3'}, {'value': '2.4', 'groupId': 'OG005', 'lowerLimit': '2.4', 'upperLimit': '2.4'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '2.7'}, {'value': '3.3', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '4.0'}]}]}, {'title': '240 min', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000', 'lowerLimit': '3.0', 'upperLimit': '3.5'}, {'value': '3.9', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '8.0'}, {'value': '2.9', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '4.3'}, {'value': '7.4', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '10.9'}, {'value': '3.4', 'groupId': 'OG004', 'lowerLimit': '2.6', 'upperLimit': '4.2'}, {'value': '2.6', 'groupId': 'OG005', 'lowerLimit': '2.6', 'upperLimit': '2.6'}, {'value': '2.5', 'groupId': 'OG006', 'lowerLimit': '2.5', 'upperLimit': '2.6'}, {'value': '5.3', 'groupId': 'OG007', 'lowerLimit': '2.6', 'upperLimit': '9.3'}]}]}, {'title': '255 min', 'categories': [{'measurements': [{'value': '3.1', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '3.6'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '1.6', 'upperLimit': '8.7'}, {'value': '8.5', 'groupId': 'OG002', 'lowerLimit': '1.3', 'upperLimit': '15.6'}, {'value': '4.8', 'groupId': 'OG003', 'lowerLimit': '1.1', 'upperLimit': '11.8'}, {'value': '3.8', 'groupId': 'OG004', 'lowerLimit': '2.7', 'upperLimit': '4.8'}, {'value': '2.5', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '2.5'}, {'value': '2.9', 'groupId': 'OG006', 'lowerLimit': '2.7', 'upperLimit': '3.0'}, {'value': '4.9', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '9.1'}]}]}, {'title': '270 min', 'categories': [{'measurements': [{'value': '3.3', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '3.4'}, {'value': '4.4', 'groupId': 'OG001', 'lowerLimit': '1.7', 'upperLimit': '9.4'}, {'value': '8.8', 'groupId': 'OG002', 'lowerLimit': '1.9', 'upperLimit': '15.6'}, {'value': '5.0', 'groupId': 'OG003', 'lowerLimit': '1.5', 'upperLimit': '11.9'}, {'value': '3.5', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '4.4'}, {'value': '2.7', 'groupId': 'OG005', 'lowerLimit': '2.7', 'upperLimit': '2.7'}, {'value': '2.5', 'groupId': 'OG006', 'lowerLimit': '2.4', 'upperLimit': '2.6'}, {'value': '4.8', 'groupId': 'OG007', 'lowerLimit': '2.6', 'upperLimit': '8.8'}]}]}, {'title': '285 min', 'categories': [{'measurements': [{'value': '2.9', 'groupId': 'OG000', 'lowerLimit': '2.8', 'upperLimit': '3.0'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '2.0', 'upperLimit': '10.7'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '1.4', 'upperLimit': '2.5'}, {'value': '4.4', 'groupId': 'OG003', 'lowerLimit': '1.2', 'upperLimit': '10.4'}, {'value': '2.8', 'groupId': 'OG004', 'lowerLimit': '2.5', 'upperLimit': '3.1'}, {'value': '2.5', 'groupId': 'OG005', 'lowerLimit': '2.5', 'upperLimit': '2.5'}, {'value': '2.6', 'groupId': 'OG006', 'lowerLimit': '2.6', 'upperLimit': '2.6'}, {'value': '4.3', 'groupId': 'OG007', 'lowerLimit': '2.7', 'upperLimit': '7.6'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion', 'description': 'Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion', 'unitOfMeasure': 'psi', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)'}, {'type': 'SECONDARY', 'title': 'Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '24 ga Catheter, Dose Flush, Single-step Rate Scheme'}, {'id': 'OG001', 'title': '24 ga Catheter, No Dose Flush, Single-step Rate Scheme'}, {'id': 'OG002', 'title': '24 ga Catheter, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG003', 'title': '24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG004', 'title': '25 ga Needle, Dose Flush, Single-step Rate Scheme'}, {'id': 'OG005', 'title': '25 ga Needle, No Dose Flush, Single-step Rate Scheme'}, {'id': 'OG006', 'title': '25 ga Needle, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG007', 'title': '25 ga Needle, No Dose Flush, Up-titrated Rate Scheme'}], 'classes': [{'title': '1 attempt', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}]}, {'title': '2 attempts', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'end of catheter/needle placement', 'unitOfMeasure': 'Subjects', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurements)'}, {'type': 'SECONDARY', 'title': 'Cumulative Fluid Volume Delivered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '24 ga Catheter, Dose Flush, Single-step Rate Scheme'}, {'id': 'OG001', 'title': '24 ga Catheter, No Dose Flush, Single-step Rate Scheme'}, {'id': 'OG002', 'title': '24 ga Catheter, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG003', 'title': '24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG004', 'title': '25 ga Needle, Dose Flush, Single-step Rate Scheme'}, {'id': 'OG005', 'title': '25 ga Needle, No Dose Flush, Single-step Rate Scheme'}, {'id': 'OG006', 'title': '25 ga Needle, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG007', 'title': '25 ga Needle, No Dose Flush, Up-titrated Rate Scheme'}], 'classes': [{'title': '5 min', 'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '20.7', 'upperLimit': '20.8'}, {'value': '21.4', 'groupId': 'OG001', 'lowerLimit': '20.6', 'upperLimit': '22.2'}, {'value': '4.2', 'groupId': 'OG002', 'lowerLimit': '4.2', 'upperLimit': '4.2'}, {'value': '3.8', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '4.2'}, {'value': '21.1', 'groupId': 'OG004', 'lowerLimit': '21.1', 'upperLimit': '21.1'}, {'value': '20.7', 'groupId': 'OG005', 'lowerLimit': '20.7', 'upperLimit': '20.7'}, {'value': '4.1', 'groupId': 'OG006', 'lowerLimit': '4.1', 'upperLimit': '4.1'}, {'value': '4.1', 'groupId': 'OG007', 'lowerLimit': '4.1', 'upperLimit': '4.2'}]}]}, {'title': '10 min', 'categories': [{'measurements': [{'value': '41.2', 'groupId': 'OG000', 'lowerLimit': '41.2', 'upperLimit': '41.2'}, {'value': '41.3', 'groupId': 'OG001', 'lowerLimit': '39.6', 'upperLimit': '42.9'}, {'value': '11.7', 'groupId': 'OG002', 'lowerLimit': '11.4', 'upperLimit': '11.9'}, {'value': '11.5', 'groupId': 'OG003', 'lowerLimit': '10.4', 'upperLimit': '12.3'}, {'value': '42.0', 'groupId': 'OG004', 'lowerLimit': '41.9', 'upperLimit': '42.1'}, {'value': '41.2', 'groupId': 'OG005', 'lowerLimit': '41.2', 'upperLimit': '41.2'}, {'value': '12.1', 'groupId': 'OG006', 'lowerLimit': '12.0', 'upperLimit': '12.1'}, {'value': '11.9', 'groupId': 'OG007', 'lowerLimit': '11.8', 'upperLimit': '12.1'}]}]}, {'title': '60 min', 'categories': [{'measurements': [{'value': '250', 'groupId': 'OG000', 'lowerLimit': '249', 'upperLimit': '250'}, {'value': '249', 'groupId': 'OG001', 'lowerLimit': '248', 'upperLimit': '250'}, {'value': '249', 'groupId': 'OG002', 'lowerLimit': '248', 'upperLimit': '249'}, {'value': '240', 'groupId': 'OG003', 'lowerLimit': '228', 'upperLimit': '247'}, {'value': '249', 'groupId': 'OG004', 'lowerLimit': '247', 'upperLimit': '250'}, {'value': '249', 'groupId': 'OG005', 'lowerLimit': '249', 'upperLimit': '249'}, {'value': '248', 'groupId': 'OG006', 'lowerLimit': '247', 'upperLimit': '248'}, {'value': '246', 'groupId': 'OG007', 'lowerLimit': '243', 'upperLimit': '248'}]}]}, {'title': '120 min', 'categories': [{'measurements': [{'value': '448', 'groupId': 'OG000', 'lowerLimit': '447', 'upperLimit': '449'}, {'value': '450', 'groupId': 'OG001', 'lowerLimit': '448', 'upperLimit': '452'}, {'value': '449', 'groupId': 'OG002', 'lowerLimit': '447', 'upperLimit': '451'}, {'value': '447', 'groupId': 'OG003', 'lowerLimit': '447', 'upperLimit': '448'}, {'value': '449', 'groupId': 'OG004', 'lowerLimit': '448', 'upperLimit': '450'}, {'value': '447', 'groupId': 'OG005', 'lowerLimit': '447', 'upperLimit': '447'}, {'value': '448', 'groupId': 'OG006', 'lowerLimit': '446', 'upperLimit': '449'}, {'value': '446', 'groupId': 'OG007', 'lowerLimit': '441', 'upperLimit': '448'}]}]}, {'title': '180 min', 'categories': [{'measurements': [{'value': '649', 'groupId': 'OG000', 'lowerLimit': '647', 'upperLimit': '650'}, {'value': '650', 'groupId': 'OG001', 'lowerLimit': '648', 'upperLimit': '652'}, {'value': '649', 'groupId': 'OG002', 'lowerLimit': '647', 'upperLimit': '651'}, {'value': '647', 'groupId': 'OG003', 'lowerLimit': '647', 'upperLimit': '648'}, {'value': '649', 'groupId': 'OG004', 'lowerLimit': '648', 'upperLimit': '650'}, {'value': '647', 'groupId': 'OG005', 'lowerLimit': '647', 'upperLimit': '647'}, {'value': '650', 'groupId': 'OG006', 'lowerLimit': '649', 'upperLimit': '650'}, {'value': '646', 'groupId': 'OG007', 'lowerLimit': '641', 'upperLimit': '648'}]}]}, {'title': '240 min', 'categories': [{'measurements': [{'value': '848', 'groupId': 'OG000', 'lowerLimit': '847', 'upperLimit': '849'}, {'value': '850', 'groupId': 'OG001', 'lowerLimit': '848', 'upperLimit': '853'}, {'value': '849', 'groupId': 'OG002', 'lowerLimit': '847', 'upperLimit': '851'}, {'value': '848', 'groupId': 'OG003', 'lowerLimit': '847', 'upperLimit': '849'}, {'value': '849', 'groupId': 'OG004', 'lowerLimit': '848', 'upperLimit': '850'}, {'value': '847', 'groupId': 'OG005', 'lowerLimit': '847', 'upperLimit': '847'}, {'value': '847', 'groupId': 'OG006', 'lowerLimit': '845', 'upperLimit': '848'}, {'value': '846', 'groupId': 'OG007', 'lowerLimit': '841', 'upperLimit': '848'}]}]}, {'title': '285 min', 'categories': [{'measurements': [{'value': '998', 'groupId': 'OG000', 'lowerLimit': '995', 'upperLimit': '1000'}, {'value': '1000', 'groupId': 'OG001', 'lowerLimit': '998', 'upperLimit': '1002'}, {'value': '999', 'groupId': 'OG002', 'lowerLimit': '997', 'upperLimit': '1000'}, {'value': '997', 'groupId': 'OG003', 'lowerLimit': '997', 'upperLimit': '998'}, {'value': '999', 'groupId': 'OG004', 'lowerLimit': '998', 'upperLimit': '1000'}, {'value': '997', 'groupId': 'OG005', 'lowerLimit': '997', 'upperLimit': '997'}, {'value': '997', 'groupId': 'OG006', 'lowerLimit': '997', 'upperLimit': '997'}, {'value': '996', 'groupId': 'OG007', 'lowerLimit': '991', 'upperLimit': '998'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion', 'unitOfMeasure': 'mL', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (two subjects excluded due to technical errors in fluid pressure measurement)'}, {'type': 'SECONDARY', 'title': 'Technical Challenges Encountered During Fluid Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '3', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': '24 ga Catheter, Dose Flush, Single-step Rate Scheme'}, {'id': 'OG001', 'title': '24 ga Catheter, No Dose Flush, Single-step Rate Scheme'}, {'id': 'OG002', 'title': '24 ga Catheter, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG003', 'title': '24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG004', 'title': '25 ga Needle, Dose Flush, Single-step Rate Scheme'}, {'id': 'OG005', 'title': '25 ga Needle, No Dose Flush, Single-step Rate Scheme'}, {'id': 'OG006', 'title': '25 ga Needle, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'OG007', 'title': '25 ga Needle, No Dose Flush, Up-titrated Rate Scheme'}], 'classes': [{'title': 'Any Technical Challenge', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Catheter Kinking', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Occlusion Alarm', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}, {'title': 'Intervention Needed to Secure/Maintain Infusion', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at any occurence of a defined challenge or at end of infusion if no challenges occurred', 'description': 'Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (two subjects excluded due to technical error in in-line fluid pressure measurement)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '24 ga Catheter, Dose Flush, Single-step Rate Scheme'}, {'id': 'FG001', 'title': '24 ga Catheter, No Dose Flush, Single-step Rate Scheme'}, {'id': 'FG002', 'title': '24 ga Catheter, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'FG003', 'title': '24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme'}, {'id': 'FG004', 'title': '25 ga Needle, Dose Flush, Single-step Rate Scheme'}, {'id': 'FG005', 'title': '25 ga Needle, No Dose Flush, Single-step Rate Scheme'}, {'id': 'FG006', 'title': '25 ga Needle, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'FG007', 'title': '25 ga Needle, No Dose Flush, Up-titrated Rate Scheme'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': '24 ga Catheter, Dose Flush, Single-step Rate Scheme'}, {'id': 'BG001', 'title': '24 ga Catheter, No Dose Flush, Single-step Rate Scheme'}, {'id': 'BG002', 'title': '24 ga Catheter, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'BG003', 'title': '24 ga Catheter, No Dose Flush, Up-titrated Rate Scheme'}, {'id': 'BG004', 'title': '25 ga Needle, Dose Flush, Single-step Rate Scheme'}, {'id': 'BG005', 'title': '25 ga Needle, No Dose Flush, Single-step Rate Scheme'}, {'id': 'BG006', 'title': '25 ga Needle, Dose Flush, Up-titrated Rate Scheme'}, {'id': 'BG007', 'title': '25 ga Needle, No Dose Flush, Up-titrated Rate Scheme'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.9', 'groupId': 'BG000', 'lowerLimit': '33.5', 'upperLimit': '58.3'}, {'value': '32.6', 'groupId': 'BG001', 'lowerLimit': '25.4', 'upperLimit': '36.7'}, {'value': '39.6', 'groupId': 'BG002', 'lowerLimit': '21.4', 'upperLimit': '50.0'}, {'value': '29.3', 'groupId': 'BG003', 'lowerLimit': '19.9', 'upperLimit': '46.4'}, {'value': '35.4', 'groupId': 'BG004', 'lowerLimit': '20.3', 'upperLimit': '50.5'}, {'value': '39.7', 'groupId': 'BG005', 'lowerLimit': '37.0', 'upperLimit': '42.4'}, {'value': '28.2', 'groupId': 'BG006', 'lowerLimit': '24.1', 'upperLimit': '32.3'}, {'value': '20.9', 'groupId': 'BG007', 'lowerLimit': '19.9', 'upperLimit': '21.9'}, {'value': '33.3', 'groupId': 'BG008', 'lowerLimit': '19.9', 'upperLimit': '58.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '12', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '8', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '20', 'groupId': 'BG008'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'Strategic business decision (not related to safety or efficacy concerns)', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-17', 'studyFirstSubmitDate': '2010-04-30', 'resultsFirstSubmitDate': '2011-09-12', 'studyFirstSubmitQcDate': '2010-05-03', 'lastUpdatePostDateStruct': {'date': '2011-10-24', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-12', 'studyFirstPostDateStruct': {'date': '2010-05-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Measured In-line Fluid Pressure', 'timeFrame': 'each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion', 'description': 'Maximum fluid pressure measured (15 sec period) in delivery line during subcutaneous fluid infusion at specified time point after start of infusion'}], 'secondaryOutcomes': [{'measure': 'Number of Attempts Needed for Successful Subcutaneous Catheter/Needle Placement', 'timeFrame': 'end of catheter/needle placement'}, {'measure': 'Cumulative Fluid Volume Delivered', 'timeFrame': 'each minute for the first 15 minutes of fluid infusion, every 5 minutes for the next 45 minutes of infusion, and every 15 minutes thereafter until the end of infusion'}, {'measure': 'Technical Challenges Encountered During Fluid Infusion', 'timeFrame': 'at any occurence of a defined challenge or at end of infusion if no challenges occurred', 'description': 'Observed challenges, including catheter kinking, catheter/needle dislodgement/pull-out, infusion pump alarm, other technical problems'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['dehydration', 'fluid therapy', 'hyaluronoglucosaminidase', 'hyaluronidase', 'hypodermoclysis', 'clysis', 'subcutaneous hydration', 'subcutaneous rehydration', 'hyaluronan', 'rHuPH20'], 'conditions': ['Dehydration']}, 'descriptionModule': {'briefSummary': "The purpose is to characterize the in-line pressure profiles associated with several infusion technique factors during subcutaneous (SC) infusion of Lactated Ringer's solution, preceded by recombinant human hyaluronidase (hylenex). The safety and tolerability of hylenex-augmented SC infusion of Lactated Ringer's solution fluid is also being evaluated."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female, aged 18 to 60 years, inclusive.\n* Body mass index 19.0 to 35.0 kg/m2\n* Intact normal skin without potentially obscuring tattoos, pigmentation, or lesions on the upper back in the area intended for infusion\n* Free from any clinically significant abnormality on the basis of medical/medication history or physical examination\n* Vital signs and clinical laboratory parameters within normal range or, if outside normal range, deemed not clinically significant\n* Negative urine drug and alcohol screens.\n\nExclusion Criteria:\n\n* Upper back pathology that could interfere with study outcome.\n* History of congestive heart failure, known coronary heart disease, active or recent pulmonary disease, or renal insufficiency.\n* Rales on lung auscultation.\n* Known allergy to hyaluronidase or any other ingredient in the formulation of hylenex recombinant\n* Treatment with furosemide, benzodiazepines, or phenytoin.\n* Pregnancy or breastfeeding.\n* Exposure to any experimental drug within 30 days prior to study admission, or previous participation in this study.\n* Any other reason which, in the investigator's opinion, would prevent the safe participation in the study."}, 'identificationModule': {'nctId': 'NCT01116102', 'acronym': 'INFUSE-AT1A', 'briefTitle': 'Study of In-line Pressure Using Various Techniques of Subcutaneous Administration of Fluids Enabled by Human Recombinant Hyaluronidase (INFUSE-AT1A)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Baxter Healthcare Corporation'}, 'officialTitle': 'The INcreased Flow Utilizing Subcutaneously-Enabled Fluids Administration Technique 1A Study (INFUSE-AT 1A): A Randomized, Parallel Group Study to Evaluate the In-line Pressure, Flow Rate, Safety and Tolerability of Hylenex-facilitated Subcutaneous Fluid Administration In Healthy Volunteers Using Various Subcutaneous Infusion Techniques', 'orgStudyIdInfo': {'id': '1838-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '24 ga catheter, dose flush, single-step rate scheme', 'description': "Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.", 'interventionNames': ["Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution"]}, {'type': 'EXPERIMENTAL', 'label': '24 ga catheter, no dose flush, single-step rate scheme', 'description': "Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.", 'interventionNames': ["Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution"]}, {'type': 'EXPERIMENTAL', 'label': '24 ga catheter, dose flush, up-titrated rate scheme', 'description': "Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.", 'interventionNames': ["Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution"]}, {'type': 'EXPERIMENTAL', 'label': '24 ga catheter, no dose flush, up-titrated rate scheme', 'description': "Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 24 gauge plastic catheter; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.", 'interventionNames': ["Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution"]}, {'type': 'EXPERIMENTAL', 'label': '25 ga needle, dose flush, single-step rate scheme', 'description': "Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.", 'interventionNames': ["Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution"]}, {'type': 'EXPERIMENTAL', 'label': '25 ga needle, no dose flush, single-step rate scheme', 'description': "Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 250 mL/h for the first hour and 200 mL/hr for the remainder of the infusion.", 'interventionNames': ["Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution"]}, {'type': 'EXPERIMENTAL', 'label': '25 ga needle, dose flush, up-titrated rate scheme', 'description': "Single 150 U subcutaneous (SC) dose of HYLENEX and 3 mL Lactated Ringer's solution flush administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.", 'interventionNames': ["Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution"]}, {'type': 'EXPERIMENTAL', 'label': '25 ga needle, no dose flush, up-titrated rate scheme', 'description': "Single 150 U subcutaneous (SC) dose of HYLENEX (without a Lactated Ringer's solution flush) administered through 25 gauge metal butterfly needle; followed by SC infusion of 1000 mL Lactated Ringer's solution via large-volume infusion pump at 50 mL/h for the first 5 min, 100 mL/h for the next 5 min, 285 mL/h for the next 50 min and 200 mL/h for the remainder of the infusion.", 'interventionNames': ["Drug: Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution"]}], 'interventions': [{'name': "Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution", 'type': 'DRUG', 'otherNames': ['rHuPH20', 'LR solution'], 'description': "Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution", 'armGroupLabels': ['24 ga catheter, dose flush, single-step rate scheme', '24 ga catheter, dose flush, up-titrated rate scheme', '24 ga catheter, no dose flush, single-step rate scheme', '24 ga catheter, no dose flush, up-titrated rate scheme', '25 ga needle, dose flush, single-step rate scheme', '25 ga needle, dose flush, up-titrated rate scheme', '25 ga needle, no dose flush, single-step rate scheme', '25 ga needle, no dose flush, up-titrated rate scheme']}]}, 'contactsLocationsModule': {'locations': [{'zip': '26505', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Kendle International, Inc. Drug Study Unit', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}], 'overallOfficials': [{'name': 'George Harb, MD, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baxter Healthcare Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Halozyme Therapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}