Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2025-12-31 @ 2:36 AM
Study NCT ID:
NCT01083732
Status:
COMPLETED
Last Update Posted:
2016-12-28
First Post:
2010-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Austria', 'Belgium', 'Czechia', 'France', 'Hungary', 'Latvia', 'Netherlands', 'Norway', 'Slovakia', 'Spain', 'Ukraine']}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '800-243-0127', 'title': 'Boehringer Ingelheim Call Center', 'phoneExt': '+1', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All adverse events (AEs) during the treatment period, up to 6 days.', 'description': 'For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.', 'eventGroups': [{'id': 'EG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)', 'otherNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)', 'otherNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 9, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'title': '1h (N= 4, 9, NA)', 'categories': [{'measurements': [{'value': '79.4', 'spread': '45.6', 'groupId': 'OG000'}, {'value': '90.6', 'spread': '48.8', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG002'}]}]}, {'title': '2h (N=6, 9, 2)', 'categories': [{'measurements': [{'value': '129.0', 'spread': '9.84', 'groupId': 'OG000'}, {'value': '114.0', 'spread': '37.9', 'groupId': 'OG001'}, {'value': '26.0', 'spread': '62.6', 'groupId': 'OG002'}]}]}, {'title': '4h (N=6, 9, NA)', 'categories': [{'measurements': [{'value': '91.0', 'spread': '23.0', 'groupId': 'OG000'}, {'value': '87.7', 'spread': '31.6', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG002'}]}]}, {'title': '6h (N=6, 9, NA)', 'categories': [{'measurements': [{'value': '62.9', 'spread': '32.6', 'groupId': 'OG000'}, {'value': '56.2', 'spread': '34.2', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG002'}]}]}, {'title': '10h (N=6, 9, NA)', 'categories': [{'measurements': [{'value': '34.8', 'spread': '41.4', 'groupId': 'OG000'}, {'value': '28.2', 'spread': '37.0', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG002'}]}]}, {'title': '50h (N=NA, NA, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG001'}, {'value': '46.0', 'spread': '64.7', 'groupId': 'OG002'}]}]}, {'title': '72h (N=NA, NA, 3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG001'}, {'value': '11.9', 'spread': '47.8', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate', 'description': 'Plasma concentration of total dabigatran (SUM BIBR 953 ZW)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.\n\nPKS (evaluable cases)'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Free Dabigatran (BIBR 953 ZW).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'title': '1h (N= 4, 9, NA)', 'categories': [{'measurements': [{'value': '68.5', 'spread': '43.8', 'groupId': 'OG000'}, {'value': '80.0', 'spread': '43.9', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG002'}]}]}, {'title': '2h (N=6, 9, 2)', 'categories': [{'measurements': [{'value': '101.0', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '98.5', 'spread': '35.3', 'groupId': 'OG001'}, {'value': '23.4', 'spread': '72.2', 'groupId': 'OG002'}]}]}, {'title': '4h (N=6, 9, NA)', 'categories': [{'measurements': [{'value': '75.3', 'spread': '30.2', 'groupId': 'OG000'}, {'value': '74.5', 'spread': '31.7', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG002'}]}]}, {'title': '6h (N=6, 9, NA)', 'categories': [{'measurements': [{'value': '51.6', 'spread': '40.0', 'groupId': 'OG000'}, {'value': '48.4', 'spread': '37.9', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG002'}]}]}, {'title': '10h (N=6, 9, NA)', 'categories': [{'measurements': [{'value': '28.1', 'spread': '49.8', 'groupId': 'OG000'}, {'value': '23.7', 'spread': '40.3', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG002'}]}]}, {'title': '50h (N=NA, NA, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG001'}, {'value': '37.3', 'spread': '60.7', 'groupId': 'OG002'}]}]}, {'title': '72h (N=NA, NA, 3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG001'}, {'value': '8.43', 'spread': '44.0', 'groupId': 'OG002'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate', 'description': 'Plasma concentration of free dabigatran (BIBR 953 ZW)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS (evaluable cases)'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)', 'description': 'The patients aged 1 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'title': '1h (N= 13, NA)', 'categories': [{'measurements': [{'value': '3.82', 'spread': '107', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '2h (N=5, 2)', 'categories': [{'measurements': [{'value': '3.23', 'spread': '74.4', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules', 'groupId': 'OG001'}]}]}, {'title': '4h (N=15, NA)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '6h (N=1, NA)', 'categories': [{'measurements': [{'value': '1.05', 'spread': 'NA', 'comment': 'All patients except one patient had values below the limit of quantification.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '10h (N=15, NA)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '50h (N=NA, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules', 'groupId': 'OG001'}]}]}, {'title': '72h (N=NA, 3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate', 'description': 'Plasma concentration of unchanged dabigatran etexilate (BIBR 1048 BS).\n\nSome values are "NA" because Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the Geometric Mean (gMean) and Geometric Coefficient of Variation (gCV) is not calculated according to internal rules.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS (evaluable cases)'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Metabolite BIBR 951 BS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)', 'description': 'The patients aged 1 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'title': '1h (N=13, NA)', 'categories': [{'measurements': [{'value': '4.88', 'spread': '82.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '2h (N=15, 2)', 'categories': [{'measurements': [{'value': '3.55', 'spread': '83.0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules', 'groupId': 'OG001'}]}]}, {'title': '4h (N=4, NA)', 'categories': [{'measurements': [{'value': '1.71', 'spread': '52.8', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '6h (N=15, NA)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '10h (N=15, NA)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '50h (N=NA, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules', 'groupId': 'OG001'}]}]}, {'title': '72h (N=NA, 3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate', 'description': 'Plasma concentration of metabolite BIBR 951 BS', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS (evaluable cases)'}, {'type': 'PRIMARY', 'title': 'Plasma Concentration of Metabolite BIBR 1087 SE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <12 Years)', 'description': 'The patients aged 1 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'title': '1h (N=12, NA)', 'categories': [{'measurements': [{'value': '2.31', 'spread': '54.0', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '2h (N=8, 2)', 'categories': [{'measurements': [{'value': '1.51', 'spread': '38.5', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG001'}]}]}, {'title': '4h (N=1, NA)', 'categories': [{'measurements': [{'value': '1.18', 'spread': 'NA', 'comment': 'All patients except one patient had values below the limit of quantification.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '6h (N=15, NA)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Values below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '10h (N=15, NA)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Values below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG001'}]}]}, {'title': '50h (N=NA, 2)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG001'}]}]}, {'title': '72h (N=NA, 3)', 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for single dose group', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Values below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the gMean and gCV is not calculated according to internal rules.', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate', 'description': 'Plasma concentration of metabolite BIBR 1087 SE', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.'}, {'type': 'PRIMARY', 'title': 'Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'title': 'Ebase (N=6, 7)', 'categories': [{'measurements': [{'value': '32.3', 'spread': '24.6', 'groupId': 'OG000'}, {'value': '34.9', 'spread': '24.5', 'groupId': 'OG001'}]}]}, {'title': 'E2 (N=6, 9)', 'categories': [{'measurements': [{'value': '47.5', 'spread': '24.7', 'groupId': 'OG000'}, {'value': '77.0', 'spread': '54.6', 'groupId': 'OG001'}]}]}, {'title': 'E10 (N=5, 8)', 'categories': [{'measurements': [{'value': '40.3', 'spread': '19.6', 'groupId': 'OG000'}, {'value': '58.4', 'spread': '40.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at predose and 2 and 10 h after intake of study medication.', 'description': 'Central measurement of aPTT (activated partial thromboplastin time) at predose and 2 and 10 h after intake of study medication. For multiple dose patients only local measurements were planned. The Standard Deviation presented below is actually the % coefficient of variation.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.'}, {'type': 'PRIMARY', 'title': 'Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'title': 'Ebase (N=6, 6)', 'categories': [{'measurements': [{'value': '36.9', 'spread': '7.49', 'groupId': 'OG000'}, {'value': '36.8', 'spread': '10.5', 'groupId': 'OG001'}]}]}, {'title': 'E2 (N=6, 7)', 'categories': [{'measurements': [{'value': '79.8', 'spread': '5.15', 'groupId': 'OG000'}, {'value': '73.6', 'spread': '22.1', 'groupId': 'OG001'}]}]}, {'title': 'E10 (N=5, 7)', 'categories': [{'measurements': [{'value': '49.7', 'spread': '5.36', 'groupId': 'OG000'}, {'value': '52.2', 'spread': '10.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at predose and 2 and 10 h after intake of study medication.', 'description': 'Central measurement of ECT (ecarin clotting time) at predose and 2 and 10 h after intake of study medication. ECT was not planned to be measured in the multiple dose group. The Standard Deviation presented below are actually the % coefficient of variation', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS (evaluable cases)'}, {'type': 'PRIMARY', 'title': 'Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'title': 'Ebase (N=6, 9, 2)', 'categories': [{'measurements': [{'value': '31.9', 'spread': '4.67', 'groupId': 'OG000'}, {'value': '35.6', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '32.9', 'spread': '4.73', 'groupId': 'OG002'}]}]}, {'title': 'E2 (N=6, 9, 2)', 'categories': [{'measurements': [{'value': '46.6', 'spread': '6.02', 'groupId': 'OG000'}, {'value': '53.6', 'spread': '18.4', 'groupId': 'OG001'}, {'value': '34.3', 'spread': '1.24', 'groupId': 'OG002'}]}]}, {'title': 'E10 (N=6, 9, NA)', 'categories': [{'measurements': [{'value': '35.5', 'spread': '6.02', 'groupId': 'OG000'}, {'value': '39.7', 'spread': '9.76', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Time-point is not applicable for multiple dose group', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'at predose and 2 and 10 h after intake of study medication.', 'description': 'Central measurement of dTT (diluted thrombin time) at predose and 2 and 10 h after intake of study medication. The Standard Deviation presented below are actually the % coefficient of variation', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PKS (evaluable cases)'}, {'type': 'PRIMARY', 'title': 'Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'categories': [{'measurements': [{'value': '129', 'spread': '9.84', 'groupId': 'OG000'}, {'value': '116', 'spread': '38.6', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'Cmax (maximum measured concentration of total dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.'}, {'type': 'PRIMARY', 'title': 'Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation).'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '9.84', 'groupId': 'OG000', 'lowerLimit': '1.92', 'upperLimit': '2.20'}, {'value': '2.00', 'spread': '38.6', 'groupId': 'OG001', 'lowerLimit': '1.03', 'upperLimit': '4.02'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'tmax (time from dosing to maximum measured concentration of total dabigatran in plasma).\n\nEndpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.'}, {'type': 'PRIMARY', 'title': 'AUC0-tz (Area Under the Concentration Time Curve of the Total Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'categories': [{'measurements': [{'value': '715', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '658', 'spread': '32.5', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'AUC0-tz (area under the concentration time curve of the total dabigatran in plasma over the time interval 0 up to the last quantifiable data point).\n\nEndpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.'}, {'type': 'PRIMARY', 'title': 'Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'categories': [{'measurements': [{'value': '101', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '102', 'spread': '36.9', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'Cmax (maximum measured concentration of free dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.'}, {'type': 'PRIMARY', 'title': 'Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.99', 'spread': '9.84', 'groupId': 'OG000', 'lowerLimit': '1.92', 'upperLimit': '2.20'}, {'value': '2.00', 'spread': '38.6', 'groupId': 'OG001', 'lowerLimit': '1.08', 'upperLimit': '2.08'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'tmax (time from dosing to maximum measured concentration of free dabigatran in plasma).\n\nEndpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.'}, {'type': 'PRIMARY', 'title': 'AUC0-tz (Area Under the Concentration Time Curve of the Free Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'categories': [{'measurements': [{'value': '581', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '566', 'spread': '32.2', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'AUC0-tz (area under the concentration time curve of the free dabigatran in plasma over the time interval 0 up to the last quantifiable data point).\n\nEndpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).', 'unitOfMeasure': 'ng*h/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic set (PKS): This patient set included all treated patients who provided at least one pharmacokinetic/ pharmacodynamic (PK/PD) observation and had no important protocol violations (PVs) with respect to the statistical analysis of PK or PD endpoints.'}, {'type': 'PRIMARY', 'title': 'Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '32.5', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 days', 'description': "Major: Fatal bleeding, Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL in 24-h-period,bleeding that was retroperitoneal,pulmonary,intracranial,or otherwise involved the central nervous system,bleeding that required surgical intervention in an operating suite. CRNM: Overt bleeding for which a blood product was administered \\& which was not directly attributable to the patient's underlying medical condition,bleeding that required medical or surgical intervention to restore haemostasis,other than in an operating suite. Minor: Any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding. For multiple dosing,all events with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for single dosing,all events with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Any Adverse Events During the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '32.5', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 days', 'description': 'Percentage of patients with any adverse events during the treatment period. For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment were assigned to the on-treatment period. For patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Tolerability of Study Medication- Taste Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'title': 'Very Good', 'categories': [{'measurements': [{'value': '0', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '0', 'spread': '32.5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Good', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '44.44', 'groupId': 'OG001'}, {'value': '33.33', 'groupId': 'OG002'}]}]}, {'title': 'Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '66.67', 'groupId': 'OG002'}]}]}, {'title': 'Very Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '33.33', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Missing', 'categories': [{'measurements': [{'value': '100.00', 'groupId': 'OG000'}, {'value': '22.22', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (immediately after dosing)', 'description': 'The investigator was to provide a global clinical assessment of tolerability including patient taste assessment.This assessment was based on 6-point scale (Very good, good, satisfactory, bad, very bad, missing). The taste assessment was only provided when the patient was old enough to evaluate the taste.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '32.5', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the treatment period, Up to 6 days', 'description': 'Percentage of patients with changes in laboratory and clinical parameters such as liver enzymes and physical examination.\n\nClinically Relevant Abnormalities for Laboratory Parameters were reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}, {'type': 'SECONDARY', 'title': 'Global Assessment of Tolerability of Study Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'OG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'classes': [{'title': 'Good', 'categories': [{'measurements': [{'value': '33.33', 'spread': '22.5', 'groupId': 'OG000'}, {'value': '11.11', 'spread': '32.5', 'groupId': 'OG001'}, {'value': '100.00', 'groupId': 'OG002'}]}]}, {'title': 'Satisfactory', 'categories': [{'measurements': [{'value': '16.67', 'groupId': 'OG000'}, {'value': '22.22', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Not satisfactory', 'categories': [{'measurements': [{'value': '33.33', 'groupId': 'OG000'}, {'value': '44.44', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Bad', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '22.22', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Not assessable', 'categories': [{'measurements': [{'value': '16.67', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 (immediately after dosing)', 'description': 'The investigator was to provide a global clinical assessment of tolerability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years):', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'FG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'FG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '20 patients were enrolled, 18 patients were entered and treated, 2 patients were screening failures.', 'preAssignmentDetails': 'Open-label, multicentre, non-randomised, uncontrolled, single arm study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 1 to <2 Years)', 'description': 'The patients aged 1 to \\<2 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'BG001', 'title': 'Dabigatran Etexilate (Single Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a single dose of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'BG002', 'title': 'Dabigatran Etexilate (Multiple Dose, Age Group 2 to <12 Years)', 'description': 'The patients aged 2 to \\<12 years were orally administered a multiple dose (3 days, twice daily) of dabigatran etexilate (Dabigatran etexilate oral liquid formulation (6.25 mg/mL) after reconstitution from dabigatran etexilate granules (167.5 mg) and solvent for oral liquid formulation)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.0', 'groupId': 'BG000'}, {'value': '5.2', 'spread': '2.6', 'groupId': 'BG001'}, {'value': '8.3', 'spread': '2.5', 'groupId': 'BG002'}, {'value': '4.3', 'spread': '3.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Treated set (TS): This patient set included all subjects who were dispensed study medication and were documented to have taken at least 1 dose of trial medication.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-02', 'studyFirstSubmitDate': '2010-03-08', 'resultsFirstSubmitDate': '2016-08-17', 'studyFirstSubmitQcDate': '2010-03-08', 'lastUpdatePostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-11-02', 'studyFirstPostDateStruct': {'date': '2010-03-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Concentration of Total Dabigatran (SUM BIBR 953 ZW)', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate', 'description': 'Plasma concentration of total dabigatran (SUM BIBR 953 ZW)'}, {'measure': 'Plasma Concentration of Free Dabigatran (BIBR 953 ZW).', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate', 'description': 'Plasma concentration of free dabigatran (BIBR 953 ZW)'}, {'measure': 'Plasma Concentration of Unchanged Dabigatran Etexilate (BIBR 1048 BS)', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate', 'description': 'Plasma concentration of unchanged dabigatran etexilate (BIBR 1048 BS).\n\nSome values are "NA" because Values were below the limit of quantification. Not calculated as reliable estimation can only be performed when at least 2/3 of the data are available and thus the Geometric Mean (gMean) and Geometric Coefficient of Variation (gCV) is not calculated according to internal rules.'}, {'measure': 'Plasma Concentration of Metabolite BIBR 951 BS', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate', 'description': 'Plasma concentration of metabolite BIBR 951 BS'}, {'measure': 'Plasma Concentration of Metabolite BIBR 1087 SE', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate and at 2 h, 50 h, and 72 h after multiple dose administration of dabigatran etexilate', 'description': 'Plasma concentration of metabolite BIBR 1087 SE'}, {'measure': 'Central Measurement of Activated Partial Thromboplastin Time (aPTT) at Predose and 2 and 10 h After Intake of Study Medication.', 'timeFrame': 'at predose and 2 and 10 h after intake of study medication.', 'description': 'Central measurement of aPTT (activated partial thromboplastin time) at predose and 2 and 10 h after intake of study medication. For multiple dose patients only local measurements were planned. The Standard Deviation presented below is actually the % coefficient of variation.'}, {'measure': 'Central Measurement of Ecarin Clotting Time (ECT) at Predose and 2 and 10 h After Intake of Study Medication.', 'timeFrame': 'at predose and 2 and 10 h after intake of study medication.', 'description': 'Central measurement of ECT (ecarin clotting time) at predose and 2 and 10 h after intake of study medication. ECT was not planned to be measured in the multiple dose group. The Standard Deviation presented below are actually the % coefficient of variation'}, {'measure': 'Central Measurement of Diluted Thrombin Time (dTT) at Predose and 2 and 10 h After Intake of Study Medication.', 'timeFrame': 'at predose and 2 and 10 h after intake of study medication.', 'description': 'Central measurement of dTT (diluted thrombin time) at predose and 2 and 10 h after intake of study medication. The Standard Deviation presented below are actually the % coefficient of variation'}, {'measure': 'Cmax (Maximum Measured Concentration of Total Dabigatran in Plasma)', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'Cmax (maximum measured concentration of total dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).'}, {'measure': 'Tmax (Time From Dosing to Maximum Measured Concentration of Total Dabigatran in Plasma)', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'tmax (time from dosing to maximum measured concentration of total dabigatran in plasma).\n\nEndpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).'}, {'measure': 'AUC0-tz (Area Under the Concentration Time Curve of the Total Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'AUC0-tz (area under the concentration time curve of the total dabigatran in plasma over the time interval 0 up to the last quantifiable data point).\n\nEndpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).'}, {'measure': 'Cmax (Maximum Measured Concentration of Free Dabigatran in Plasma)', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'Cmax (maximum measured concentration of free dabigatran in plasma). Endpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of Cmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).'}, {'measure': 'Tmax (Time From Dosing to Maximum Measured Concentration of Free Dabigatran in Plasma)', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'tmax (time from dosing to maximum measured concentration of free dabigatran in plasma).\n\nEndpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of tmax (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).'}, {'measure': 'AUC0-tz (Area Under the Concentration Time Curve of the Free Dabigatran in Plasma Over the Time Interval 0 up to the Last Quantifiable Data Point)', 'timeFrame': 'At 1 hour (h), 2 h, 4 h, 6 h, and 10 h after single administration of dabigatran etexilate', 'description': 'AUC0-tz (area under the concentration time curve of the free dabigatran in plasma over the time interval 0 up to the last quantifiable data point).\n\nEndpoint can only be calculated for single dose patients. For multiple dose patients the time points do not allow calculation of AUC0-tz (no profile, only one measurement after selected doses, refer to primary outcome no. 1 and 2).'}, {'measure': 'Percentage of Patients With Incidence of Any Bleeding Events (Major, Clinically Relevant Non-major (CRNM) and Minor) During the Treatment Period.', 'timeFrame': 'Up to 6 days', 'description': "Major: Fatal bleeding, Clinically overt bleeding associated with decrease in haemoglobin of at least 2 g/dL in 24-h-period,bleeding that was retroperitoneal,pulmonary,intracranial,or otherwise involved the central nervous system,bleeding that required surgical intervention in an operating suite. CRNM: Overt bleeding for which a blood product was administered \\& which was not directly attributable to the patient's underlying medical condition,bleeding that required medical or surgical intervention to restore haemostasis,other than in an operating suite. Minor: Any overt or macroscopic evidence of bleeding that did not fulfil the criteria for either major bleeding or CRNM bleeding. For multiple dosing,all events with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment and for single dosing,all events with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period."}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With Any Adverse Events During the Treatment Period', 'timeFrame': 'Up to 6 days', 'description': 'Percentage of patients with any adverse events during the treatment period. For patients with multiple dosing, all AEs with an onset date after the date of first dose until the end of trial treatment including 3 days after the last treatment were assigned to the on-treatment period. For patients with single dosing, all AEs with an onset during the 48-h-period after study medication intake were assigned to the on-treatment period.'}, {'measure': 'Global Assessment of Tolerability of Study Medication- Taste Assessment', 'timeFrame': 'Day 1 (immediately after dosing)', 'description': 'The investigator was to provide a global clinical assessment of tolerability including patient taste assessment.This assessment was based on 6-point scale (Very good, good, satisfactory, bad, very bad, missing). The taste assessment was only provided when the patient was old enough to evaluate the taste.'}, {'measure': 'Percentage of Patients With Changes in Laboratory and Clinical Parameters Such as Liver Enzymes and Physical Examination', 'timeFrame': 'During the treatment period, Up to 6 days', 'description': 'Percentage of patients with changes in laboratory and clinical parameters such as liver enzymes and physical examination.\n\nClinically Relevant Abnormalities for Laboratory Parameters were reported.'}, {'measure': 'Global Assessment of Tolerability of Study Medication', 'timeFrame': 'Day 1 (immediately after dosing)', 'description': 'The investigator was to provide a global clinical assessment of tolerability of study medication by the patient.This assessment was based on 5-point scale (good, satisfactory, not satisfactory, bad, not assessable).'}]}, 'conditionsModule': {'conditions': ['Venous Thromboembolism']}, 'descriptionModule': {'briefSummary': 'To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data', 'detailedDescription': 'Purpose:'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n1. males or females 1 to less than 12 years of age\n2. objective diagnosis of primary VTE\n3. completion of planned treatment course with LMWH or OAC for primary VTE\n4. written informed consent by parent (legal guardian) and patient assent (if applicable)\n\nExclusion criteria:\n\n1. weight less than 9 kg\n2. conditions associated with increased risk of bleeding\n3. patients who have any condition that would not allow safe participation in study Note: Further exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT01083732', 'briefTitle': 'Safety and Tolerability of Dabigatran Etexilate Solution in Children 1 to < 12 Years of Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Single Dose Open-label PK/PD, Safety and Tolerability Study of Dabigatran Etexilate Mesilate Given at the End of Standard Anticoagulant Therapy in Successive Groups of Children Aged 2 Years to Less Than 12 Years Followed by 1 Year to Less Than 2 Years', 'orgStudyIdInfo': {'id': '1160.89'}, 'secondaryIdInfos': [{'id': '2009-013618-29', 'type': 'EUDRACT_NUMBER', 'domain': 'EudraCT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dabigatran etexilate', 'description': 'treatment with dabigatran oral solution as a single dose', 'interventionNames': ['Drug: dabigatran etexilate']}], 'interventions': [{'name': 'dabigatran etexilate', 'type': 'DRUG', 'description': 'Experimental dose chosen based on age and weight', 'armGroupLabels': ['dabigatran etexilate']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'city': 'Roma', 'country': 'Italy', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'city': 'Vilnius', 'country': 'Lithuania', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 54.68916, 'lon': 25.2798}}, {'city': "Kazan'", 'country': 'Russia', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 55.78874, 'lon': 49.12214}}, {'city': 'Zurich', 'country': 'Switzerland', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}, {'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Boehringer Ingelheim Investigational Site', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Boehringer Ingelheim', 'role': 'STUDY_CHAIR', 'affiliation': 'Boehringer Ingelheim'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}