Trial · NCT00538785
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 12 of 12
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Reporting Adverse Events Through Study Day 150 | Days 0-150 | Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall. |
| Primary | Number of Subjects Reporting Serious Adverse Events Through Study Day 150 | Days 0-150 | Serious adverse events were those that resulted in death; were life-threatening; resulted in subject hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed above. |
| Primary | Number of Subjects Reporting Laboratory Adverse Events | Days 0-150 | |
| Secondary | The Number of Subjects Hospitalized for RSV Infection. | Days 0-150 | An RSV hospitalization was defined as one of the following: 1) Cardiac/respiratory hospitalization with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory, or 2) New onset of lower respiratory tract symptoms with an objective measure of worsening respiratory status in an already hospitalized subject with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory (nosocomial RSV hospitalization), or 3) Death demonstrated to be caused by RSV (based on virologic evidence and either clinical history or autopsy). |
| Secondary | The Number of Subjects With RSV Outpatient MA-LRI for Season 2 Only. | Days 0-150 | An RSV outpatient MA-LRI was defined as an outpatient medically-attended event designated by the principal investigator as a lower respiratory illness with a positive real-time RT-PCR RSV diagnostic test performed at a central laboratory. |
| Secondary | Number of Subjects Who Had Anti-motavizumab Antibodies Detected | Days 0-150 | ECLA-based method |
| Secondary | Mean Trough Serum Concentration of Motavizumab at Pre-dose 1 | Pre-dose 1 | Trough serum concentrations (ug/mL) of motavizumab at pre-dose 1 |
| Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 1 | 30 days post-dose 1 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 1 |
| Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 2 | 30 days post-dose 2 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 2 |
| Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 3 | 30 days post-dose 3 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 3 |
| Secondary | Mean Trough Serum Concentration of Motavizumab at 30 Days Post-dose 4 | 30 days post-dose 4 | Trough serum concentrations (ug/mL) of motavizumab at 30 days post-dose 4 |
| Secondary | Mean Trough Serum Concentrations of Motavizumab in Subjects Who Underwent Cardiac Surgery With Cardiopulmonary Bypass | Days 0-150 | Subjects who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to have a blood sample taken for determination of study drug concentrations prior to receipt of another dose of study drug immediately following surgery. |
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.
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GET https://conductscience.org/api/trials/v1/NCT00538785/registered