Trial Outcomes & Findings for 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 (NCT NCT03332459)
NCT ID: NCT03332459
Last Updated: 2021-04-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
Up to 2 years
Results posted on
2021-04-13
Participant Flow
Participants who previously received lumicitabine or placebo in study 64041575RSV2004 (NCT03333317) were enrolled in this long term follow-up (LTFU) study.
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
3
|
1
|
3
|
|
Overall Study
COMPLETED
|
3
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Placebo
n=3 Participants
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 Participants
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
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.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
16 months
STANDARD_DEVIATION 13.08 • n=99 Participants
|
17 months
STANDARD_DEVIATION NA • n=107 Participants
|
6.3 months
STANDARD_DEVIATION 2.52 • n=206 Participants
|
12 months
STANDARD_DEVIATION 9.35 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
5 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Region of Enrollment
JAPAN
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
7 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this long term follow up (LTFU) study.
Percentage of participants with asthma diagnosed by physician were reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 Participants
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
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.
|
|---|---|---|---|
|
Percentage of Participants With Asthma After Respiratory Syncytial Virus (RSV) Infection
|
0 percentage of participants
Interval 0.0 to 56.15
|
0 percentage of participants
Interval 0.0 to 79.35
|
0 percentage of participants
Interval 0.0 to 56.15
|
PRIMARY outcome
Timeframe: Up to 2 yearsPopulation: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
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.
Outcome measures
| Measure |
Placebo
n=3 Participants
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 Participants
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
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.
|
|---|---|---|---|
|
Percentage of Wheezing Days in Participants Within the First 2 Years After RSV Infection
|
0.03 percentage of wheezing days
Standard Deviation 0.058
|
0.00 percentage of wheezing days
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
2.53 percentage of wheezing days
Standard Deviation 4.388
|
SECONDARY outcome
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, 24Population: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
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%.
Outcome measures
| Measure |
Placebo
n=3 Participants
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 Participants
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
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.
|
|---|---|---|---|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 4
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 6
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
2.00 percentage of wheezing days per month
Standard Deviation 3.464
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 7
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 9
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
4.33 percentage of wheezing days per month
Standard Deviation 7.506
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 15
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
6.00 percentage of wheezing days per month
Standard Deviation 10.392
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 21
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 1
|
1.00 percentage of wheezing days per month
Standard Deviation 1.732
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
1.00 percentage of wheezing days per month
Standard Deviation 1.732
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 2
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
1.00 percentage of wheezing days per month
Standard Deviation 1.732
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 3
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
5.67 percentage of wheezing days per month
Standard Deviation 9.815
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 5
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 8
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 10
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
3.33 percentage of wheezing days per month
Standard Deviation 5.774
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 11
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
5.00 percentage of wheezing days per month
Standard Deviation 8.660
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 12
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
5.67 percentage of wheezing days per month
Standard Deviation 9.815
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 13
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
6.33 percentage of wheezing days per month
Standard Deviation 10.970
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 14
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
4.33 percentage of wheezing days per month
Standard Deviation 7.506
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 16
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
7.67 percentage of wheezing days per month
Standard Deviation 13.279
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 17
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
4.00 percentage of wheezing days per month
Standard Deviation 6.928
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 18
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 19
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 20
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
1.00 percentage of wheezing days per month
Standard Deviation 1.732
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 22
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 23
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
4.00 percentage of wheezing days per month
Standard Deviation 6.928
|
|
Percentage of Wheezing Days in Participants Per Month After RSV Infection
Month 24
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
0.00 percentage of wheezing days per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 percentage of wheezing days per month
Standard Deviation 0.00
|
SECONDARY outcome
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, 24Population: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
Number of wheezing episodes in participants per month after the RSV infection based on information reported by the parent/caregiver were reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 Participants
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
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.
|
|---|---|---|---|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 5
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 11
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
1.00 wheezing episodes per month
Standard Deviation 1.732
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 24
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 1
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 2
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 3
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 4
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 6
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 7
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 8
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 9
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 10
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 12
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
1.00 wheezing episodes per month
Standard Deviation 1.732
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 13
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
1.00 wheezing episodes per month
Standard Deviation 1.732
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 14
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.67 wheezing episodes per month
Standard Deviation 1.155
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 15
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 16
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 17
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 18
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 19
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 20
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.33 wheezing episodes per month
Standard Deviation 0.577
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 21
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 22
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
|
Number of Wheezing Episodes in Participants Per Month After the RSV Infection
Month 23
|
0.00 wheezing episodes per month
Standard Deviation 0.00
|
0.00 wheezing episodes per month
Standard Deviation NA
Here 'NA' signifies that standard deviation was not calculated as only one participant was evaluated.
|
0.67 wheezing episodes per month
Standard Deviation 1.155
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
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.
Outcome measures
| Measure |
Placebo
n=3 Participants
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 Participants
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Reportable Adverse Events (AEs)
|
3 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
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.
Outcome measures
| Measure |
Placebo
n=3 Participants
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 Participants
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: 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.
The number of respiratory infections per participant, based on information reported by the parent/caregiver were reported.
Outcome measures
| Measure |
Placebo
n=3 Participants
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 Participants
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=2 Participants
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.
|
|---|---|---|---|
|
Number of Respiratory Infections Per Participant
|
10.7 infections per participant
Standard Deviation 4.62
|
6.0 infections per participant
Standard Deviation 0.00
|
19.5 infections per participant
Standard Deviation 6.36
|
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: All Enrolled analysis set included all participants from 64041575RSV2004 study who were enrolled in this LTFU study.
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.
Outcome measures
| Measure |
Placebo
n=3 Participants
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 Participants
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 Participants
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.
|
|---|---|---|---|
|
Number of Participants With Medical Encounters
Hospital Inpatient Department Visits
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Medical Encounters
Hospital Outpatient Department Visits
|
3 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Medical Encounters
Medical Practitioner Office Visits
|
2 Participants
|
1 Participants
|
1 Participants
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Lumicitabine 60/40 mg/kg LD/MD
Serious events: 1 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=3 participants at risk
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 participants at risk
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Enterocolitis
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Gastrointestinal disorders
Inguinal Hernia
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Exanthema Subitum
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Gastroenteritis Norovirus
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Gastroenteritis Rotavirus
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
Other adverse events
| Measure |
Placebo
n=3 participants at risk
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.
|
Lumicitabine 40/20 Milligrams/Kilogram (mg/kg) Loading Dose/Maintenance Dose (LD/MD)
n=1 participants at risk
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.
|
Lumicitabine 60/40 mg/kg LD/MD
n=3 participants at risk
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.
|
|---|---|---|---|
|
Infections and infestations
Adenovirus Infection
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Bronchitis
|
66.7%
2/3 • Up to 2 years (during this long term follow up study)
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.
|
100.0%
1/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Enterocolitis Viral
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Exanthema Subitum
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Nasopharyngitis
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Pharyngitis
|
66.7%
2/3 • Up to 2 years (during this long term follow up study)
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.
|
100.0%
1/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Tonsillitis
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
100.0%
1/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
66.7%
2/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
33.3%
1/3 • Up to 2 years (during this long term follow up study)
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.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
66.7%
2/3 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/1 • Up to 2 years (during this long term follow up study)
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.
|
0.00%
0/3 • Up to 2 years (during this long term follow up study)
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER