Clinical Trial Results:
A Phase 2b Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rilematovir (JNJ-53718678) in Adult Outpatients with Respiratory Syncytial Virus (RSV) Infection who are at High Risk for RSV-related Disease Progression
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Summary
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EudraCT number |
2020-005980-30 |
Trial protocol |
SE DE ES IT PL HU BG |
Global end of trial date |
14 Apr 2022
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Results information
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Results version number |
v1(current) |
This version publication date |
14 Apr 2023
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First version publication date |
14 Apr 2023
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
53718678RSV2008
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04978337 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Janssen Research & Development, LLC
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Sponsor organisation address |
920 Route 202, Raritan, United States, 08869
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Public contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Scientific contact |
Clinical Registry Group, Janssen Research & Development, LLC, ClinicalTrialsEU@its.jnj.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
14 Apr 2022
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Apr 2022
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
The main objective of this trial was to evaluate efficacy of rilematovir compared to placebo with respect to the time to resolution of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) symptoms.
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Protection of trial subjects |
This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
07 Oct 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Bulgaria: 1
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Country: Number of subjects enrolled |
Hungary: 1
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Country: Number of subjects enrolled |
Poland: 1
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Country: Number of subjects enrolled |
United States: 2
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Worldwide total number of subjects |
5
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EEA total number of subjects |
3
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
4
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From 65 to 84 years |
1
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85 years and over |
0
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Recruitment
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Recruitment details |
- | |||||||||||||||
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Pre-assignment
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Screening details |
5 randomised subjects received study treatment and were included in the analysis. Out of 5, 4 subjects completed the study. | |||||||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | |||||||||||||||
Roles blinded |
Subject, Investigator | |||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Placebo | |||||||||||||||
Arm description |
Subject received oral dose of placebo matching to rilematovir twice daily for 7 days. | |||||||||||||||
Arm type |
Placebo | |||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received placebo matching to rilematovir twice daily for 7 days.
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Arm title
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Rilematovir 250 mg bid | |||||||||||||||
Arm description |
Subjects received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days. | |||||||||||||||
Arm type |
Experimental | |||||||||||||||
Investigational medicinal product name |
Rilematovir
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Investigational medicinal product code |
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Other name |
JNJ-53718678
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Pharmaceutical forms |
Film-coated tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Subjects received rilematovir 250 mg twice daily for 7 days.
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Baseline characteristics reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subject received oral dose of placebo matching to rilematovir twice daily for 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Rilematovir 250 mg bid
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Reporting group description |
Subjects received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Placebo
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Reporting group description |
Subject received oral dose of placebo matching to rilematovir twice daily for 7 days. | ||
Reporting group title |
Rilematovir 250 mg bid
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Reporting group description |
Subjects received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days. | ||
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End point title |
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Baseline [1] | |||||||||||||||||||||||||||
End point description |
RSV LRTD symptoms (cough, short of breath, wheezing, coughing up phlegm [sputum]) as assessed by RiiQ symptom scale score at baseline was reported. RiiQ symptom scale was a 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate, and 3=Severe. Higher scores indicated greater severity. The LRTD symptom score was calculated as the mean of the LRTD symptom scores. Intent-to-Treat infected (ITT-i) analysis set included subjects who were randomised and treated (at least 1 dose) and had RSV infection confirmed by central laboratory analysis. Subjects with confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection (positive test by central laboratory analysis) were excluded. Here, 'n' (number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
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End point type |
Primary
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End point timeframe |
Baseline
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this primary endpoint. |
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End point title |
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 3 [2] | ||||||||||||||||||
End point description |
RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 3 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher scores indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
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End point type |
Primary
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End point timeframe |
Day 3
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| Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 14 [3] | ||||||||||||||||||||||||
End point description |
RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 14 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher score indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
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End point type |
Primary
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End point timeframe |
Day 14
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| Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 8 [4] | ||||||||||||||||||||||||
End point description |
RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 8 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher scores indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
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End point type |
Primary
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End point timeframe |
Day 8
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| Notes [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 21 [5] | ||||||||||||||||||||||||
End point description |
RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 21 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher score indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
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End point type |
Primary
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End point timeframe |
Day 21
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| Notes [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 28 [6] | ||||||||||||||||||||||||
End point description |
RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 28 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher score indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
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End point type |
Primary
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End point timeframe |
Day 28
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| Notes [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Respiratory Syncytial Virus (RSV) Lower Respiratory Tract Disease (LRTD) Symptoms as Assessed by Respiratory Infection Intensity and Impact Questionnaire (RiiQ) Symptom Scale Score at Day 35 [7] | ||||||||||||||||||||||||
End point description |
RSV LRTD symptoms (cough,short of breath,wheezing,coughing up phlegm[sputum]) as assessed by RiiQ symptom scale score at Day 35 was reported. RiiQ symptom scale was 13-items questionnaire rated on 4-point scale. Each symptom and total score was ranged from 0-3 where 0=None,1=Mild,2=Moderate,3=Severe. Higher score indicated greater severity. LRTD symptom score was calculated as the mean of LRTD symptom scores. In this endpoint, only those individual subjects who had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis)were excluded.Here, 'N'(number of subjects analyzed) signifies number of subjects with available data for this endpoint and 'n'(number analysed) represent number of subjects evaluable for specified category. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
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End point type |
Primary
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End point timeframe |
Day 35
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| Notes [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No inferential statistics was planned for this primary endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||
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End point title |
Percentage of Subjects with New Antibiotic Use, or New Use or Increased Dose of Systemic or Inhaled Corticosteroids and Bronchodilator, or Home Oxygen Supplementation | |||||||||||||||||||||
End point description |
New antibiotic use, or new use or increased dose of systemic or inhaled corticosteroids and bronchodilators, or home oxygen supplementation were reported. ITT-i analysis set included all subjects who were randomised and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Subjects with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
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End point type |
Secondary
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End point timeframe |
Up to Day 35
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Percentage of Subjects with Post-Baseline RSV-related Complications | ||||||||||||
End point description |
RSV-related complications were reported. The RSV-related complications included pulmonary complications (primary viral pneumonia, bronchitis, respiratory failure, secondary bacterial pneumonia, and exacerbations of underlying chronic pulmonary diseases [such as chronic obstructive pulmonary disease {COPD} and asthma]) and extrapulmonary complications (cardiovascular and cerebrovascular disease events, congestive heart failure [CHF] or exacerbation of underlying CHF, acute exacerbation of chronic kidney disease, severe dehydration, decompensation of previously controlled diabetes mellitus, and other airway infections). Complications after first intake of study drug were considered for this endpoint. ITT-i analysis set included all subjects who were randomised and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Subjects with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
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End point type |
Secondary
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End point timeframe |
Up to Day 35
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects with Unscheduled Outpatient Clinic Visits, Emergency Room Visits or Hospitalization for Respiratory Infection | |||||||||||||||||||||
End point description |
Unscheduled outpatient clinic visits, emergency room visits or hospitalization for respiratory infection were reported. ITT-i analysis set included all subjects who were randomised and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Subjects with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
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End point type |
Secondary
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End point timeframe |
Up to Day 35
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| No statistical analyses for this end point | ||||||||||||||||||||||
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End point title |
Percentage of Subjects with Treatment-emergent Abnormal Clinical Laboratory Findings | ||||||||||||||||||
End point description |
Abnormal clinical laboratory findings were reported. Laboratory abnormalities were determined by division of microbiology and infectious diseases(DMID) toxicity as Grade 1:mild (transient or mild discomfort;no medical intervention/therapy required); Grade 2: moderate (mild-moderate limitation in activity-some assistance may be needed;no or minimal medical intervention/therapy required); Grade 3: severe(severe marked limitation in activity, some assistance usually required;medical intervention/therapy required, hospitalizations possible); Grade 4: life-threatening (extreme limitation in activity, significant assistance required; significant medical intervention/therapy required, hospitalization care probable). A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. Safety analysis set included all subjects who took at least 1 dose of study intervention.
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End point type |
Secondary
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End point timeframe |
Up to Day 35
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| No statistical analyses for this end point | |||||||||||||||||||
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End point title |
Percentage of Subjects with Treatment-emergent Adverse Events (TEAEs) | ||||||||||||
End point description |
An adverse events (AEs) is any untoward medical occurrence in a clinical study subject administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention. Any AE which occurred at or after the initial administration of study intervention through the end of the study (that is, Day 35) was considered treatment-emergent. Safety analysis set included all subjects who took at least 1 dose of study intervention.
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End point type |
Secondary
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End point timeframe |
Up to Day 35
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Subjects Meeting a Composite Endpoint of Either Developing RSV-Related Complications and/or Needing RSV-related Medical Attendance | ||||||||||||
End point description |
Percentage of subjects meeting a composite endpoint of either developing RSV-related complications (pulmonary and extra-pulmonary) and/or needing RSV-related medical attendance was derived. ITT-i analysis set included all subjects who were randomised and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Subjects with confirmed SARS-CoV-2 infection (positive test by central laboratory analysis) were excluded.
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End point type |
Secondary
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End point timeframe |
Up to Day 35
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| No statistical analyses for this end point | |||||||||||||
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End point title |
RSV Viral Load Over Time | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
RSV viral load (Subtype: RSV A and RSV B) was measured over time by quantitative reverse transcription polymerase chain reaction (qRT-PCR) in nasal swab specimens collected at clinic visits and at home. Only those timepoints and RSV subtype (RSV A or RSV B) for which individual subjects had data were reported. ITT-i analysis set included randomised and treated subjects with central laboratory confirmed RSV infection. Subjects with confirmed SARS-CoV-2 infection(positive test by central laboratory analysis) were excluded. Here, 'N'(number of subject analysed) signifies number of subjects who were evaluable for this endpoint and 'n'(number analyzed) represents number of subjects evaluable at specified timepoints. Here, ‘99999’ indicate that data was not collected as subjects was randomised to other treatment arm.
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End point type |
Secondary
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End point timeframe |
Baseline, Days 3, 5, 8, 15, 21
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| No statistical analyses for this end point | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
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End point title |
Percentage of Subjects with Treatment-emergent Abnormal Vital Signs Findings | ||||||||||||
End point description |
Abnormal vital parameters included pulse rate: abnormally low:<=45 bpm, abnormally high:>=120 bpm; Systolic Blood Pressure: abnormally low:<=90 millimeter of mercury (mmHg), Grade 1(mild):>140 mmHg to <160 mmHg, Grade 2(moderate): >=160 mmHg to <180 mmHg, Grade 3(severe):>=180 mmHg; Diastolic BP: abnormally low:<=50 mmHg, Grade 1:>90 mmHg to <100 mmHg, Grade 2:>=100 mmHg to <110 mmHg, Grade 3:>=110 mmHg; Respiratory rate: Grade 1(mild):17-20 breaths/minute, Grade 2(moderate):21-25 breaths/minute, Grade 3(severe):>25 breaths/minute, Grade 4(potentially life threatening):intubation; Oxygen saturation: abnormally low:<95%; Temperature: abnormally high:>38.0 degree celsius. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. Safety analysis set included all subjects who took at least 1 dose of study intervention.
|
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End point type |
Secondary
|
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End point timeframe |
Up to Day 35
|
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|
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| No statistical analyses for this end point | |||||||||||||
|
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End point title |
Percentage of Subjects with Treatment-emergent Abnormalities in Electrocardiograms (ECGs) | ||||||||||||
End point description |
Various ECG variables assessed were heart rate: abnormally low (less than or equal to [<=] 45 beats per minute [bpm]), abnormally high (greater than or equal to [>=] 120 bpm); PR interval: abnormally high (>=210 milliseconds [msec]); QRS interval: abnormally high (>=120 msec); QTc: borderline prolonged: >450 msec and <=480 msec, prolonged: >480 msec and <=500 msec, pathologicaly prolonged: >500 msec. A treatment emergent abnormality is any abnormality not present at baseline and occurring post first administration or worsening versus baseline post first administration. Safety analysis set included all subjects who took at least 1 dose of study intervention.
|
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End point type |
Secondary
|
||||||||||||
End point timeframe |
Up to Day 35
|
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|
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| No statistical analyses for this end point | |||||||||||||
|
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End point title |
Plasma Concentration of Rilematovir [8] | ||||||||||||||||||||||||||||
End point description |
Plasma concentration of rilematovir was reported. This endpoint was planned to be analyzed for specified arm only. In this endpoint, only those timepoints for which individual subjects had data were reported. Pharmacokinetic (PK) analysis set included all subjects who were randomised and treated (at least one dose) and had RSV infection confirmed by central laboratory analysis. Here, 'N' (number of subject analysed) signifies number of subjects with available data for this endpoint .
|
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End point type |
Secondary
|
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End point timeframe |
Day 1: 1 hour post dose, Day 3: pre-dose and 1 hour post dose, and Follow-up Day 8
|
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| Notes [8] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: This endpoint was planned to be analyzed for specified arm only. |
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|
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||
|
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|
Adverse events information [1]
|
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Timeframe for reporting adverse events |
Up to Day 35
|
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Adverse event reporting additional description |
Safety analysis set included all subjects who took at least 1 dose of study intervention.
|
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Assessment type |
Non-systematic | |||||||||||||||
|
Dictionary used for adverse event reporting
|
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Dictionary name |
MedDRA | |||||||||||||||
Dictionary version |
24.1
|
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|
Reporting groups
|
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Reporting group title |
Rilematovir 250 mg
|
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Reporting group description |
Subjects received oral dose of rilematovir 250 milligrams (mg) twice daily for 7 days. | |||||||||||||||
Reporting group title |
Placebo
|
|||||||||||||||
Reporting group description |
Subjects received oral dose of placebo matching to rilematovir twice daily for 7 days. | |||||||||||||||
|
||||||||||||||||
| Frequency threshold for reporting non-serious adverse events: 0% | ||||||||||||||||
|
||||||||||||||||
| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Data could not be reported as only 5 subjects enrolled in this study who did not experience any non-serious adverse events. |
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|
|||
Substantial protocol amendments (globally) |
|||
| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
|||
| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
|||
| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| As the study was terminated early, a low number of subjects were enrolled, hence some efficacy analyses were not performed per change in the planned analysis. Thereby, data were analysed for safety and selected efficacy parameters only. | |||
