Trial · NCT03116347
Outcomes41
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 41
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Safety: Number of Participants With Any Severe Related Treatment-emergent Adverse Events (TEAEs) Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Rate of Any Severe Related TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Number of Severe Related TEAEs/Infusion | NUMBER |
| PRIMARY | Safety: Number of Participants With Any Related Serious TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Safety: Rate of Any Related Serious TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Number of Related Serious TEAEs/Infusion | NUMBER |
| SECONDARY | Efficacy: Change From Baseline in Total Serum Trough Levels of Immunoglobulin G (IgG) at Month 12 | Baseline, Month 12 | Full analysis set included all participants who provide informed consent and meet enrollment eligibility. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | Gram per liter (g/L) | MEAN |
| SECONDARY | Efficacy: Change From Baseline in Serum Trough Levels of IgG Subclasses at Month 12 | Baseline, Month 12 | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure. | g/L | MEAN |
| SECONDARY | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Clostridium Tetani Toxoid IgG at Month 12 | Baseline, Month 12 | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure. Specific antibody data were not scheduled to be collected at Epoch 2 Month 0, so for most participants baseline could not be defined and change from baseline was not reported in HYQVIA Pre-treated arm. | IU/ml | MEAN |
| SECONDARY | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Hepatitis B Virus (HBV) at Month 12 | Baseline, Month 12 | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure. Specific antibody data were not scheduled to be collected at Epoch 2 Month 0, so for most participants baseline could not be defined and change from baseline was not reported in HYQVIA Pre-treated arm. | International units per liter (IU/L) | MEAN |
| SECONDARY | Efficacy: Change From Baseline in Trough Levels of Specific Antibodies to Haemophilus Influenzae B IgG at Month 12 | Baseline, Month 12 | All participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. Here, Overall number of Participants Analyzed signifies participants who were evaluable for this outcome measure. Specific antibody data were not scheduled to be collected at Epoch 2 Month 0, so for most participants baseline could not be defined and change from baseline was not reported in HYQVIA Pre-treated arm. | Milligram per liter (mg/L) | MEAN |
| SECONDARY | Safety: Percentage of Participants Who Achieved a Treatment Interval of Three or Four Weeks in Epoch 2 | Up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Percentage of participants | NUMBER |
| SECONDARY | Safety: Percentage of Participants Who Maintained a Treatment Interval of Three or Four Weeks in Epoch 2 up to 12 Months | Up to 12 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Percentage of participants | NUMBER |
| SECONDARY | Safety: Number of Participants With Local TEAEs (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety: Rate of Local TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Number of local TEAEs/Infusion | NUMBER |
| SECONDARY | Safety: Number of Participants With Local Adverse Reaction (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety: Rate of Local Adverse Reaction Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Number of Local AR events/Infusion | NUMBER |
| SECONDARY | Safety: Number of Participants With Systemic TEAEs (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety: Rate of Systemic TEAEs Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Number of systemic TEAEs/Infusion | NUMBER |
| SECONDARY | Safety: Number of Participants With Systemic Adverse Reaction (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Safety: Rate of Systemic Adverse Reaction Per Infusion (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | Number of systemic AR events/Infusion | NUMBER |
| SECONDARY | Safety: Number of Participants With Any TEAEs (Excluding Infections) | From start of study drug administration up to 20 months | Safety analysis set included all participants in the full analysis set (enrolled set) who received at least one dose of HyQvia. | 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
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GET https://conductscience.org/api/trials/v1/NCT03116347/outcomes