Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT03332459
Status:
COMPLETED
Last Update Posted:
2021-04-13
First Post:
2017-10-16
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Argentina', 'Australia', 'Belgium', 'Brazil', 'Canada', 'Chile', 'Colombia', 'Czechia', 'Finland', 'France', 'Germany', 'Ireland', 'Israel', 'Italy', 'Malaysia', 'Netherlands', 'New Zealand', 'Panama', 'Portugal', 'Slovakia', 'South Korea', 'Spain', 'Sweden', 'Taiwan', 'Thailand', 'Ukraine', 'United Kingdom', 'United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D018357', 'term': 'Respiratory Syncytial Virus Infections'}], 'ancestors': [{'id': 'D018186', 'term': 'Pneumovirus Infections'}, {'id': 'D018184', 'term': 'Paramyxoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Medical Leader', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Due to the limited number of participants enrolled in this study (n=7), no meaningful conclusions can be made.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 2 years (during this long term follow up study)', 'description': 'Reportable AEs (Respiratory illness AEs, including subsequent RSV infections, AEs considered at least possibly related to study treatment \\[lumicitabine or placebo, as received in Study 64041575RSV2004\\], and serious adverse events) reported below. All Enrolled analysis set: all participants from 64041575RSV2004 study enrolled in this LTFU study.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Adenovirus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Enterocolitis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Exanthema Subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Rhinitis Allergic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Rhinorrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Upper Respiratory Tract Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Eczema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}], 'seriousEvents': [{'term': 'Enterocolitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Exanthema Subitum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Gastroenteritis Norovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Gastroenteritis Rotavirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 1, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 22.1'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '56.15'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '79.35'}, {'value': '0', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '56.15'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of participants with asthma diagnosed by physician were reported.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this long term follow up (LTFU) study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.03', 'spread': '0.058', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '2.53', 'spread': '4.388', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of wheezing days in participants within the first 2 Years after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days was calculated by (number of wheezing days/days of study completion - day of informed consent + 1)\\*100.', 'unitOfMeasure': 'percentage of wheezing days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.'}, {'type': 'SECONDARY', 'title': 'Percentage of Wheezing Days in Participants Per Month After RSV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '1.00', 'spread': '1.732', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '1.00', 'spread': '1.732', 'groupId': 'OG002'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '1.00', 'spread': '1.732', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '5.67', 'spread': '9.815', 'groupId': 'OG002'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '2.00', 'spread': '3.464', 'groupId': 'OG002'}]}]}, {'title': 'Month 7', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '4.33', 'spread': '7.506', 'groupId': 'OG002'}]}]}, {'title': 'Month 10', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '3.33', 'spread': '5.774', 'groupId': 'OG002'}]}]}, {'title': 'Month 11', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '5.00', 'spread': '8.660', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '5.67', 'spread': '9.815', 'groupId': 'OG002'}]}]}, {'title': 'Month 13', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '6.33', 'spread': '10.970', 'groupId': 'OG002'}]}]}, {'title': 'Month 14', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '4.33', 'spread': '7.506', 'groupId': 'OG002'}]}]}, {'title': 'Month 15', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '6.00', 'spread': '10.392', 'groupId': 'OG002'}]}]}, {'title': 'Month 16', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '7.67', 'spread': '13.279', 'groupId': 'OG002'}]}]}, {'title': 'Month 17', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '4.00', 'spread': '6.928', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 19', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 20', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '1.00', 'spread': '1.732', 'groupId': 'OG002'}]}]}, {'title': 'Month 21', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 22', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 23', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '4.00', 'spread': '6.928', 'groupId': 'OG002'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'Percentage of wheezing days in participants per month after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days per month was calculated by number of days reported in that period with wheezing, using last day - first day + 1 for reported days of wheezing and multiplied by 100%.', 'unitOfMeasure': 'percentage of wheezing days per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.'}, {'type': 'SECONDARY', 'title': 'Number of Wheezing Episodes in Participants Per Month After the RSV Infection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '0.33', 'spread': '0.577', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.577', 'groupId': 'OG002'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.577', 'groupId': 'OG002'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.577', 'groupId': 'OG002'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.577', 'groupId': 'OG002'}]}]}, {'title': 'Month 7', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 8', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 9', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.577', 'groupId': 'OG002'}]}]}, {'title': 'Month 10', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.577', 'groupId': 'OG002'}]}]}, {'title': 'Month 11', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '1.00', 'spread': '1.732', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '1.00', 'spread': '1.732', 'groupId': 'OG002'}]}]}, {'title': 'Month 13', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '1.00', 'spread': '1.732', 'groupId': 'OG002'}]}]}, {'title': 'Month 14', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.67', 'spread': '1.155', 'groupId': 'OG002'}]}]}, {'title': 'Month 15', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.577', 'groupId': 'OG002'}]}]}, {'title': 'Month 16', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.577', 'groupId': 'OG002'}]}]}, {'title': 'Month 17', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.577', 'groupId': 'OG002'}]}]}, {'title': 'Month 18', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 19', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 20', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.33', 'spread': '0.577', 'groupId': 'OG002'}]}]}, {'title': 'Month 21', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 22', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}, {'title': 'Month 23', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.67', 'spread': '1.155', 'groupId': 'OG002'}]}]}, {'title': 'Month 24', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.00', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'OG001'}, {'value': '0.00', 'spread': '0.00', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'Number of wheezing episodes in participants per month after the RSV infection based on information reported by the parent/caregiver were reported.', 'unitOfMeasure': 'wheezing episodes per month', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reportable Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 years', 'description': 'Number of participants with reportable AEs were reported. The following AEs were considered reportable (within the context of this study): respiratory illness AEs, including subsequent RSV infections, adverse events considered at least possibly related to study treatment (lumicitabine or placebo, as received in study 64041575RSV2004), and serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 years', 'description': 'SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.'}, {'type': 'SECONDARY', 'title': 'Number of Respiratory Infections Per Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.7', 'spread': '4.62', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '0.00', 'groupId': 'OG001'}, {'value': '19.5', 'spread': '6.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 years', 'description': 'The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported.', 'unitOfMeasure': 'infections per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study. Here 'N' (number of participants analyzed) included all participants who had a respiratory infection."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Medical Encounters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'OG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}], 'classes': [{'title': 'Hospital Inpatient Department Visits', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Hospital Outpatient Department Visits', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Medical Practitioner Office Visits', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 2 years', 'description': 'Number of participants with medical encounters (hospital inpatient department visits, hospital outpatient department visits, medical practitioner office visits) was reported based on information reported by the parent/caregiver.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'FG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'FG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants who previously received lumicitabine or placebo in study 64041575RSV2004 (NCT03333317) were enrolled in this long term follow-up (LTFU) study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Participants who had received placebo for the treatment of respiratory syncytial virus (RSV) infection during study 64041575RSV2004 and continued to participate in this long term follow-up (LTFU) study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'BG001', 'title': 'Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)', 'description': 'Participants who had received lumicitabine 40 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 20 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'BG002', 'title': 'Lumicitabine 60/40 mg/kg LD/MD', 'description': 'Participants who had received lumicitabine 60 mg/kg as LD (Dose 1) followed by 9 MD doses of lumicitabine 40 mg/kg twice a day for the treatment of RSV infection during study 64041575RSV2004 and continued to participate in this LTFU study were assessed for the clinical diagnosis of asthma and wheezing in infants and children.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '16', 'spread': '13.08', 'groupId': 'BG000'}, {'value': '17', 'spread': 'NA', 'comment': "Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.", 'groupId': 'BG001'}, {'value': '6.3', 'spread': '2.52', 'groupId': 'BG002'}, {'value': '12', 'spread': '9.35', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'JAPAN', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-01-30', 'size': 1160122, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-03-18T14:15', 'hasProtocol': True}, {'date': '2020-05-11', 'size': 803271, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-03-18T14:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-18', 'studyFirstSubmitDate': '2017-10-16', 'resultsFirstSubmitDate': '2021-03-18', 'studyFirstSubmitQcDate': '2017-11-01', 'lastUpdatePostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-18', 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of participants with asthma diagnosed by physician were reported.'}, {'measure': 'Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection', 'timeFrame': 'Up to 2 years', 'description': 'Percentage of wheezing days in participants within the first 2 Years after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days was calculated by (number of wheezing days/days of study completion - day of informed consent + 1)\\*100.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Wheezing Days in Participants Per Month After RSV Infection', 'timeFrame': 'Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'Percentage of wheezing days in participants per month after RSV infection based on information reported by the parent/caregiver were reported. Percentage of wheezing days per month was calculated by number of days reported in that period with wheezing, using last day - first day + 1 for reported days of wheezing and multiplied by 100%.'}, {'measure': 'Number of Wheezing Episodes in Participants Per Month After the RSV Infection', 'timeFrame': 'Month 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24', 'description': 'Number of wheezing episodes in participants per month after the RSV infection based on information reported by the parent/caregiver were reported.'}, {'measure': 'Number of Participants With Reportable Adverse Events (AEs)', 'timeFrame': 'Up to 2 years', 'description': 'Number of participants with reportable AEs were reported. The following AEs were considered reportable (within the context of this study): respiratory illness AEs, including subsequent RSV infections, adverse events considered at least possibly related to study treatment (lumicitabine or placebo, as received in study 64041575RSV2004), and serious adverse events.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 2 years', 'description': 'SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life-threatening experience, is a congenital anomaly/birth defect and may jeopardize participant and/or may require medical or surgical intervention to prevent one of the outcomes listed above.'}, {'measure': 'Number of Respiratory Infections Per Participant', 'timeFrame': 'Up to 2 years', 'description': 'The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported.'}, {'measure': 'Number of Participants With Medical Encounters', 'timeFrame': 'Up to 2 years', 'description': 'Number of participants with medical encounters (hospital inpatient department visits, hospital outpatient department visits, medical practitioner office visits) was reported based on information reported by the parent/caregiver.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Syncytial Virus Infections']}, 'descriptionModule': {'briefSummary': 'The purpose of this long-term follow-up (LTFU) study is to evaluate the incidence of the clinical diagnosis of asthma and the frequency of wheezing in infants and children with respiratory syncytial virus (RSV) infection who were treated with (lumicitabine or placebo) and have completed their last planned study-related visit in a feeding Phase 2 study (64041575RSV2004).', 'detailedDescription': 'RSV is a leading cause of lower respiratory tract disease in infants. The primary hypothesis is that treatment of RSV-infected infants/children with lumicitabine (also known as JNJ-64041575 or ALS-008176) will decrease subsequent wheezing/asthma compared to placebo (looks like lumicitabine). The participants who have completed treatment course (lumicitabine/placebo) and last study visit in a previous study, 64041575RSV2004, for the treatment of RSV infection will be enrolled in this LTFU study. The main purpose of this study is to understand the impact of lumicitabine on the occurrence of asthma/wheezing in infants/children with a history of RSV infection. The participants will be assessed via monthly calls with the parents/caregivers and also at site visits at 3, 6,12 and 24 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '39 Months', 'minimumAge': '56 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female infants and children who were previously randomized in study 64041575RSV2004 for the treatment of respiratory syncytial virus (RSV) infection and who completed the planned course of the study drug and the last study-related visit of study 64041575RSV2004\n* The participant's legally acceptable representative must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing for the participant to participate in the study\n\nExclusion Criteria:\n\n* The participants legally acceptable representative, i.e, parent/legal guardian/caregiver, is not able to maintain reliable communication with the investigator\n* Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (example, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments"}, 'identificationModule': {'nctId': 'NCT03332459', 'briefTitle': 'A Long-term Follow-up Study to Evaluate the Impact of Lumicitabine on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection', 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': 'A Long-term Follow-up of Study 64041575RSV2004 to Evaluate the Impact of Lumicitabine (JNJ-64041575) on the Incidence of Asthma and/or Wheezing in Infants and Children With a History of Respiratory Syncytial Virus Infection', 'orgStudyIdInfo': {'id': 'CR108375'}, 'secondaryIdInfos': [{'id': '2016-002095-26', 'type': 'EUDRACT_NUMBER'}, {'id': '64041575RSV2002', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lumicitabine', 'description': 'Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing lumicitabine for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of lumicitabine, frequency and type of respiratory infections and medical resource usage.', 'interventionNames': ['Drug: Lumicitabine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants who completed the last planned study-related visit in a feeding Phase 2 study (64041575RSV2004), in which they received a regimen containing placebo for the treatment of RSV infection, and who agree to participate in this follow-up study will be assessed for the incidence of the clinical diagnosis of asthma, frequency of wheezing, long-term safety of placebo, frequency and type of respiratory infections and medical resource usage.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lumicitabine', 'type': 'DRUG', 'description': 'Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.', 'armGroupLabels': ['Lumicitabine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '721-8511', 'city': 'Fukuyama', 'country': 'Japan', 'facility': 'Fukuyama City Hospital', 'geoPoint': {'lat': 34.48333, 'lon': 133.36667}}, {'zip': '036-8545', 'city': 'Hirosaki', 'country': 'Japan', 'facility': 'Hirosaki National Hospital', 'geoPoint': {'lat': 40.59306, 'lon': 140.4725}}, {'zip': '945-8585', 'city': 'Niigata', 'country': 'Japan', 'facility': 'National Hospital Organization Niigata National Hospital', 'geoPoint': {'lat': 37.92259, 'lon': 139.04125}}, {'zip': '874-0011', 'city': 'Ōita', 'country': 'Japan', 'facility': 'National Hospital Organization Beppu Medical Center', 'geoPoint': {'lat': 33.23333, 'lon': 131.6}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}