Trial · NCT00121108
Outcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 11 of 11
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Respiratory Syncytial Virus (RSV) Hospitalization | From study Day 0 through study Day 150 | The ITT population included all participants in the treatment group according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | From study Day 0 through study Day 150 | Safety population included all the participants who received any study drug. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With RSV Outpatient Medically Attended Lower Respiratory Illness (MA LRI) | From study Day 0 through study Day 150 | The ITT population included all participants in the treatment group according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Medically Attended-Otitis Media (MA-OM) Events | From study Day 0 through study Day 150 | The ITT population included all participants in the treatment group according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Frequency of MA-OM Events | From study Day 0 through study Day 150 | The ITT population included all participants in the treatment group according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Medically Attended Wheezing Episodes | From first year through 3 years | The ITT population included all participants in the treatment group according to their randomized treatment group. Here, number analyzed signified, only those participants who were analyzed from first year through 3 years. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Serious Early Childhood Wheezing Episodes | From first year through 3 years | The ITT population included all participants in the treatment group according to their randomized treatment group. Here, number analyzed signified, only those participants who were analyzed from first year through 3 years. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Frequency of Medically Attended Wheezing Events | Study Day 0 through 3 years | The ITT population included all participants in the treatment group according to their randomized treatment group. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Trough Serum Concentrations of Motavizumab | Day 0 (pre Dose 1) and Day 120 (Pre Dose 5) | Pharmacokinetics (PK) population included all participants (in seasons 1 through 3) who received at least 4 doses of motavizumab and had a post-baseline PK measurement available. Here, number analyzed signified only those participants who had adequate PK samples at the specified time points. | μg/mL | MEAN |
| SECONDARY | Number of Participants With Positive Anti-Motavizumab Antibodies After Full Dose | Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5) | Evaluable population for full dose included all participants (in season 1 through 3) who received 4 doses of motavizumab prior to ADA sample collection, and had Day 120 ADA data available. Here, number analyzed signified only those participants who had adequate ADA samples at the specified time points. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Positive Anti-Motavizumab Antibodies After Any Dose | Day 0 (Pre Dose 1) and Day 120 (Pre Dose 5) | Evaluable population for any dose included all participants (in season 1 through 3) who received at least 1 dose of motavizumab prior to ADA sample collection, and had Day 120 ADA data available. Here, number analyzed signified only those participants who had adequate ADA samples at the specified timepoints. | Participants | COUNT_OF_PARTICIPANTS |
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/NCT00121108/outcomes