Trial · NCT03842189
Outcomes81
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 81
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Maternal Participants With Treatment-emergent Adverse Events (TEAEs) | From baseline (Gestational Age [GA] Week 14) up to Postpartum (PP) Week 24 (up to 50 weeks) | Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Neonates/Infants With Adverse Events (AEs) | From Birth (PP Day 0) up to PP Week 96 | Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Maternal Participants With Treatment-emergent Serious Adverse Events (TESAEs) | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Neonates/Infants With Serious Adverse Events (SAEs) | From Birth (PP Day 0) up to PP Week 96 | Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Maternal Participants With Treatment-emergent Adverse Events of Special Interest (TEAESIs) | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | Safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Neonates/Infants With Adverse Events of Special Interest (AESIs) | From birth (PP Day 0) up to PP Week 96 | Neonates or infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline | Baseline (GA Week 14) | The full analysis set (FAS) included all maternal participants who received any dose of nipocalimab. | Beats per minute | MEAN |
| PRIMARY | Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36 | GA Week 36 | The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Beats per minute | MEAN |
| PRIMARY | Maternal Participants: Change From Baseline in ECG Parameter- Mean Ventricular Rate | Baseline (GA Week 14) and GA Week 36 | The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Beats per minute | MEAN |
| PRIMARY | Number of Maternal Participants With Treatment-emergent (TE) Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time | From baseline (Gestational Age [GA] Week 14) up to PP Week 24 (up to 50 weeks) | The safety analysis set included all maternal participants who had received at least 1 dose of nipocalimab. Here, n (number analyzed): number of participants evaluable for each category. n=0 signifies no participant was available for the analysis. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Neonates or Infants With Clinically Important Laboratory and Biomarker Immunoglobulin G (IgG) Values Over Time | From Birth (PP Day 0) up to PP Week 96 | The neonates/infants analysis set included all live births to maternal participants who received at least 1 dose of nipocalimab in the study pregnancy. Only those categories in which at least one neonates or Infants had data were reported in this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Maternal Participants: Absolute Value of Vital Signs - Body Temperature at Baseline | Baseline (GA Week 14) | The FAS included all maternal participants who received any dose of nipocalimab. | Degree Celsius | MEAN |
| PRIMARY | Maternal Participants: Absolute Value of Vital Signs - Body Temperature at GA Week 36 | GA Week 36 | The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Degree Celsius | MEAN |
| PRIMARY | Maternal Participants: Absolute Value of Vital Signs - Body Temperature at PP Week 24 | PP Week 24 | The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Degree Celsius | MEAN |
| PRIMARY | Maternal Participants: Change From Baseline in Vital Sign - Body Temperature | Baseline (GA Week 14), GA Week 36, and PP Week 24 | The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure and n (number analyzed) signifies number of participants evaluable at specified timepoints. | Degree Celsius | MEAN |
| PRIMARY | Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at Baseline | Baseline (GA Week 14) | The FAS included all maternal participants who received any dose of nipocalimab. | breaths per minute | MEAN |
| PRIMARY | Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at GA Week 36 | GA Week 36 | The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Breaths per minute | MEAN |
| PRIMARY | Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24 | PP Week 24 | The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. | Breaths per minute | MEAN |
| PRIMARY | Maternal Participants: Change From Baseline in Vital Sign - Respiratory Rate | Baseline (GA Week 14), GA Week 36, and PP Week 24 | The FAS included all maternal participants who received any dose of nipocalimab. Here, 'N' (overall number of participants analyzed) signifies number of participants evaluable for this outcome measure. Here, n (number analyzed) signifies number of participants evaluable at specified timepoints. | Breaths per minute | MEAN |
| PRIMARY | Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at Baseline | Baseline (GA Week 14) | The FAS included all maternal participants who received any dose of nipocalimab. | Beats per minute | MEAN |
Source ClinicalTrials.govtrials-2026-11-12-0.4.0
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.
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