Trial · NCT02935673
Outcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 1 | Day 1 | Pharmacokinetic (PK) analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | nanogram per milliliter (ng/mL) | MEAN |
| PRIMARY | Maximum Observed Plasma Concentration (Cmax) of JNJ-63549109 at Day 5 | Day 5 | PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | ng/mL | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 1 | Day 1 | PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | nanogram*hour per milliliter (ng*h/mL) | MEAN |
| PRIMARY | Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours After Dosing (AUC[0-24h]) of JNJ-63549109 at Day 5 | Day 5 | PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | ng*h/mL | MEAN |
| PRIMARY | Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 1 | Day 1 | PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | ng/mL | MEAN |
| PRIMARY | Trough Observed Plasma Concentration (Ctrough) of JNJ-63549109 at Day 5 | Day 5 | PK analysis was performed on safety set which included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | ng/mL | MEAN |
| PRIMARY | Least Square Mean Difference (Low and High Dose Lumicitabine Versus Placebo) of Respiratory Syncytial Virus (RSV) Ribonucleic Acid (RNA) Viral Load Area Under the Concentration-time Curve From Day 1 to 7 (AUC[1-7]) | Day 1 (Baseline) to 7 | Intent-to-treat-infected (ITT-i) set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | log10 copies/mL/day | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Adverse Events (AEs) | Up to 28 Days | Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Analyses were conducted on pooled groups across the 3 study parts. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Vital Sign Abnormalities | Up to 28 Days | Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories. Analyses were conducted on pooled groups across the 3 study parts. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With QT Interval Abnormalities | Up to 28 Days | Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Clinical Laboratory Abnormalities | Up to 28 Days | Safety set included all participants who received at least 1 dose of study drug, analyzed as treated. Here 'n' (number analyzed) signifies number of participants evaluable for specified categories. Analyses were conducted on pooled groups across the 3 study parts. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time of Hospital Stay From Study Treatment Initiation to Discharge | From study treatment initiation to discharge (Up to 28 Days) | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Hours | MEAN |
| SECONDARY | Time of Hospital Stay From Admission to Discharge | From admission to discharge (Up to 28 Days) | Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Hours | MEAN |
| SECONDARY | Time of Hospital Stay From Study Treatment Initiation to Readiness for Discharge | From study treatment initiation to readiness for discharge on Day 2 or up to Day 6 if hospitalization is prolonged | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Hours | MEAN |
| SECONDARY | Time of Hospital Stay From Admission to Readiness for Discharge | Up to 28 Days | Analysis was performed on ITT-i set. Here 'N' (number of participants analyzed) signifies number of participants evaluable for this outcome measure. Analyses were conducted on pooled groups across the 3 study parts. | Hours | MEAN |
| SECONDARY | Number of Participants Who Required to be Admitted to the Intensive Care Unit (ICU) Since Initiation of Treatment | Up to 28 Days | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Duration of Intensive Care Unit Stay | Up to 28 Days | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Overall number of participants analyzed is 0, since none of the participants were admitted to ICU since initiation of treatment. | ||
| SECONDARY | Number of Participants Who Required Supplemental Oxygen | Up to 28 Days | ITT-i set included all randomly assigned participants who received at least 1 dose of study drug and who had an RSV infection confirmed by a PCR-based assay at the central laboratory at baseline, analyzed as randomized. Analyses were conducted on pooled groups across the 3 study parts. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to End of Oxygen Supplementation | Up to 28 Days | Population included ITT-i set who required supplemental oxygen. Analyses were conducted on pooled groups across the 3 study parts. | Hours | MEAN |
| SECONDARY | Time (Number of Hours) Until Peripheral Capillary Oxygen Saturation (SpO2) Greater Than or Equal to (>=) 93 Percent (%) on Room Air Among Participants Who Were Not on Supplemental Oxygen Prior to the Onset of Respiratory Symptoms | Up to 28 Days | Data was not collected and analyzed because this study was stopped prematurely. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT02935673/outcomes