Trial · NCT00129766
Outcomes20
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 20
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Incidence of RSV Hospitalization (Includes Deaths by RSV) | Days 0 - 150 | The Intent-to-Treat (ITT) Population included all patients randomized into the study. | Participants | NUMBER |
| PRIMARY | Number of Participants Reporting Any Adverse Events (AEs) | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting Any Related AEs | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting Any Serious Adverse Events (SAEs) | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting Any Related SAEs | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting AEs by Highest Severity Grade | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinued Study Drug Due to AEs | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Who Died | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| PRIMARY | Number of Participants Reporting Changes in Vital Signs From Baseline | Days 0 - 150 | The Safety Population included all patients who received any study drug and had any safety follow-up. | participants | NUMBER |
| SECONDARY | The Incidence of Outpatient Medically-attended Lower Respiratory Illness (LRI) | Day 0 - 150 | The Intent-to-Treat (ITT) Population included all patients randomized into the study. | Participant | NUMBER |
| SECONDARY | The Incidence of RSV-specific Medically-attended Outpatient Lower Respiratory Illnesses (LRIs) Between Treatment Groups | Days 0 - 150 | Subjects were from a pre-specified subsets of sites participating in the nasal secretion sample collection for this endpoint. | Participants | NUMBER |
| SECONDARY | The Incidence of Medically-attended Otitis Media (OM) Infections | Days 0 - 150 | The Intent-to-Treat (ITT) Population included all patients randomized into the study. | Participants | NUMBER |
| SECONDARY | The Frequency of Prescribed Antibiotics for Medically-attended LRI | Days 0 - 150 | The Intent-to-Treat (ITT) Population included all patients randomized into the study. | Number of prescriptions | MEAN |
| SECONDARY | The Frequency of Prescribed Antibiotics for Medically-attended OM Infections | Days 0 - 150 | The Intent-to-Treat (ITT) Population included all patients randomized into the study. | number of prescriptions | MEAN |
| SECONDARY | The Number of Participants With Anti-motavizumab Antibodies | Day 0 - 120 | N varied at different timepoints: at pre-dose 1 N=3193; at 30 days post-dose 1 N=998; at 30 days post-dose 2 N=1049; at 30 days post-dose 3 N=1049; at 30 days post-dose 4, N=3013; at any time post baseline, N=3217 | participants | NUMBER |
| SECONDARY | The Serum Concentrations of Motavizumab at Day 0 | Day 0 | The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. | ug/mL | MEAN |
| SECONDARY | The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 1 | 30 days post Dose 1 | The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 1 measurements | ug/mL | MEAN |
| SECONDARY | The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 2 | 30 days post Dose 2 | The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 2 measurements | ug/mL | MEAN |
| SECONDARY | The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 3 | 30 days post Dose 3 | The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 3 measurements | ug/mL | MEAN |
| SECONDARY | The Trough Serum Concentrations of Motavizumab at 30 Days Post Dose 4 | 30 days post Dose 4 | The Pharmacokinetics/Immunogenicity (PK/IM) Population included all patients who received study drug and who did not receive non-study commercial palivizumab within 3 months prior to receiving the first dose of study drug. Includes subjects with both baseline and a post-dose 4 measurements | ug/mL | MEAN |
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
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT00129766/outcomes