Trial · NCT03842189
Registered outcomes81
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 81
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| 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) | An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. |
| Primary | Number of Neonates/Infants With Adverse Events (AEs) | From Birth (PP Day 0) up to PP Week 96 | An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. |
| 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) | SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. TESAEs were any SAEs occurring after the initiation of the first infusion of nipocalimab. |
| Primary | Number of Neonates/Infants With Serious Adverse Events (SAEs) | From Birth (PP Day 0) up to PP Week 96 | SAE was defined as any untoward medical occurrence that resulted in death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions, or a congenital anomaly/birth defect. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. |
| 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) | Number of maternal participants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment and with hypoalbuminemia greater than or equal to (\>=) Grade 3 (less than \[\<\]20 gram per liter \[g/L\] by National Cancer Institute of Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 criteria were considered an AESI for maternal participants. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. |
| Primary | Number of Neonates/Infants With Adverse Events of Special Interest (AESIs) | From birth (PP Day 0) up to PP Week 96 | Number of neonates/infants with TEAESIs were reported. An AE was any unfavorable and unintended sign (example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, without any judgment about causality. All infections requiring anti-infective (that is, oral or intravenous antibacterial, antiviral, or antifungal) treatment, unexpected/unusual childhood illnesses and Immunoglobulin G (IgG) concentrations \<200 milligrams per deciliter (mg/dL) at Week 24 through Week 47 or \<300 mg/dL at Week 48 through Week 96 were considered an AESI for neonates and infants. |
| Primary | Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at Baseline | Baseline (GA Week 14) | Absolute value of ECG parameter - mean ventricular rate at baseline in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities. |
| Primary | Maternal Participants: Absolute Value of Electrocardiogram (ECG) Parameter - Mean Ventricular Rate at GA Week 36 | GA Week 36 | Absolute value of ECG parameter - mean ventricular rate at GA Week 36 in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities. |
| Primary | Maternal Participants: Change From Baseline in ECG Parameter- Mean Ventricular Rate | Baseline (GA Week 14) and GA Week 36 | Change from baseline in ECG parameter- mean ventricular rate in maternal participants was reported. Electrocardiogram assessments included comments on whether the tracings were normal or abnormal, rhythm, presence of arrhythmia or conduction defects, morphology, any evidence of myocardial infarction, or ST segment, T Wave, and U Wave abnormalities. |
| 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) | Laboratory parameters included hematology, chemistry, blood Lipids panel, and Immunoglobulin G (IgG) parameters. TEAE was defined as any event occurring after the initiation of the first infusion of nipocalimab. Here, HDL: high-density lipoprotein, LDL: low-density lipoprotein. The during-pregnancy value of albumin \<20 g/L was from a local laboratory and was \>=20 g/L when analyzed at the central laboratory for the same time point. |
| 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 | Laboratory parameters included total bilirubin and biomarker included immunoglobulin G (IgG). |
| Primary | Maternal Participants: Absolute Value of Vital Signs - Body Temperature at Baseline | Baseline (GA Week 14) | Absolute value of vital signs - body temperature at baseline in maternal participants was reported. |
| Primary | Maternal Participants: Absolute Value of Vital Signs - Body Temperature at GA Week 36 | GA Week 36 | Absolute value of vital signs - body temperature at GA Week 36 in maternal participants was reported. |
| Primary | Maternal Participants: Absolute Value of Vital Signs - Body Temperature at PP Week 24 | PP Week 24 | Absolute value of vital signs - body temperature at PP Week 24 in maternal participants was reported. |
| Primary | Maternal Participants: Change From Baseline in Vital Sign - Body Temperature | Baseline (GA Week 14), GA Week 36, and PP Week 24 | Change from baseline in vital signs- body temperature in maternal participants was reported. |
| Primary | Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at Baseline | Baseline (GA Week 14) | Absolute value of vital signs -respiratory rate at baseline in maternal participants was reported. |
| Primary | Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at GA Week 36 | GA Week 36 | Absolute value of vital signs -respiratory rate at GA Week 36 in maternal participants was reported. |
| Primary | Maternal Participants: Absolute Value of Vital Signs - Respiratory Rate at PP Week 24 | PP Week 24 | Absolute value of vital signs - respiratory rate at PP Week 24 in maternal participants was reported. |
| Primary | Maternal Participants: Change From Baseline in Vital Sign - Respiratory Rate | Baseline (GA Week 14), GA Week 36, and PP Week 24 | Change from baseline in vital signs- respiratory rate in maternal participants was reported. |
| Primary | Maternal Participants: Absolute Value of Vital Signs - Pulse Rate at Baseline | Baseline (GA Week 14) | Absolute value of vital signs - pulse rate at baseline in maternal participants was reported. |
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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