| Primary | Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection | Percentage of participants with asthma diagnosed by physician were reported. | All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this long term follow up (LTFU) study. | Posted | | Number | 95% Confidence Interval | percentage of participants | | Up to 2 years | | | | ID | Title | Description |
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| OG000 | Placebo | 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. | | OG001 | Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | 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. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000(0 to 56.15)
- OG0010(0 to 79.35)
- OG0020(0 to 56.15)
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| Primary | Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection | 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. | All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study. | Posted | | Mean | Standard Deviation | percentage of wheezing days | | Up to 2 years | | | | ID | Title | Description |
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| OG000 | Placebo | 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. | | OG001 | Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | 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. | | OG002 |
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| Secondary | Percentage of Wheezing Days in Participants Per Month After RSV Infection | 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%. | All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study. | Posted | | Mean | Standard Deviation | percentage of wheezing days per month | | 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 | | | | ID | Title | Description |
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| OG000 | Placebo | 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. | | OG001 | Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | 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. |
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| Secondary | Number of Wheezing Episodes in Participants Per Month After the RSV Infection | Number of wheezing episodes in participants per month after the RSV infection based on information reported by the parent/caregiver were reported. | All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study. | Posted | | Mean | Standard Deviation | wheezing episodes per month | | 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 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | 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. | | OG001 | Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | 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. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD |
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| Secondary | Number of Participants With Reportable Adverse Events (AEs) | 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. | All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study. | Posted | | Count of Participants | | Participants | | Up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Placebo | 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. | | OG001 | Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | 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. | |
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| Secondary | Number of Participants With Serious Adverse Events (SAEs) | 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. | All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study. | Posted | | Count of Participants | | Participants | | Up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Placebo | 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. | | OG001 | Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | 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. | | OG002 |
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| Secondary | Number of Respiratory Infections Per Participant | The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported. | 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. | Posted | | Mean | Standard Deviation | infections per participant | | Up to 2 years | | | | ID | Title | Description |
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| OG000 | Placebo | 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. | | OG001 | Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | 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. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD |
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| Secondary | Number of Participants With Medical Encounters | 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. | All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study. | Posted | | Count of Participants | | Participants | | Up to 2 years | | | | ID | Title | Description |
|---|
| OG000 | Placebo | 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. | | OG001 | Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD) | 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. | | OG002 | Lumicitabine 60/40 mg/kg LD/MD | |
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