This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency (NCT02604810), a non-randomized phase 3 study. The primary outcome is AUC in the IV Phase and SC Phases: Steady-state AUC of Total IgG Over a Regular Dosing Interval.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02604810 |
| Phase | Phase 3 |
| Condition | Primary Immunodeficiency |
| Allocation | Non-Randomized |
| Design model | Sequential |
| Masking | None (open label) |
| Enrollment | 53 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Grifols Therapeutics LLC |
| Results posted | Yes |
2. Clinical Question
Population
Subjects with primary immunodeficiency were enrolled. The registry reports an enrollment of 53, while the pharmacokinetic analysis used data from 49 subjects in the intravenous phase and 39 in the subcutaneous phase. The analysis population required study-drug exposure and sufficient, valid total IgG concentration-versus-time data for calculation of the primary endpoint. These population counts describe different aspects of participation and analysis; they should not be treated as interchangeable.
Intervention
The intervention was IGSC 20%, a 20% immune globulin preparation administered subcutaneously. The study’s stated purpose included identifying a weekly subcutaneous dose that would produce steady-state total IgG exposure non-inferior to the regularly administered intravenous dose. The selected dose and the numerical exposure results are not reported in the registry record.
Comparator
The comparator was IGIV-C 10%, an immune globulin preparation administered intravenously. The record describes an open-label, non-randomized, sequential study. The two treatment phases therefore do not constitute randomized, concurrent groups, and the comparison should not be read as a like-for-like randomized control comparison.
Primary question
The primary pharmacokinetic question concerned steady-state AUC of total IgG over a regular dosing interval during the intravenous and subcutaneous phases. The study aimed to evaluate whether subcutaneous administration could achieve exposure non-inferior to intravenous administration. The AUC estimates, confidence intervals, non-inferiority margin, and conclusion about that question are not reported in the registry record.
The study also set out to compare steady-state trough total IgG concentrations after the two administration routes and to assess the safety and tolerability of IGSC 20%. A secondary outcome describes the mean pre-dose trough concentration following either route. The numerical trough findings are not reported in the registry record.
3. Trial Design
This completed Phase 3 study is titled “Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency.” The official title describes an open-label, multi-center study evaluating IGSC 20% administered for 6 months. The registry lists a non-randomized allocation, no masking, and a sequential model. Enrollment was 53. The record gives a start date of 2016-01 and primary completion at 2017-09.
The study involved an intravenous phase with IGIV-C 10% and a subcutaneous phase with IGSC 20%. The registry’s description identifies both preparations and routes. Because allocation was non-randomized and the phases were sequential, treatment route was not assigned through randomization between concurrent groups. The comparison is therefore vulnerable to differences associated with phase order, time, or changes in participants’ circumstances; the registry does not report information that would establish or rule out such influences. The observed contrast should not be interpreted as though it came from a randomized parallel-group trial.
The primary pharmacokinetic analysis used data from 49 subjects in the IV phase and 39 in the SC phase. The defined PK population included subjects who received study drugs and had sufficient and valid total IgG concentration-versus-time data to calculate the AUC endpoint for either phase. These counts are analysis-population counts, not evidence that every enrolled subject contributed usable data to both phases. The reasons individual subjects did or did not contribute phase-specific data are not reported in the registry record.
The record reports analysis of variance for the primary pharmacokinetic endpoint. It does not report the model specification, covariates, handling of repeated measurements, missing-data approach, non-inferiority margin, or detailed sequence and period considerations. The original sample-size justification is not reported in the registry record. Any sample-size figures based on the observed effect are planning illustrations, not the study’s original design justification and not observed power.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: One subject was lost to follow-up before the IGIV-C Phase.
IGIV-C 10%, 4-5 Weeks
| Stage | IGIV-C 10% First, IGSC 20% Second |
|---|---|
| STARTED | 52 |
| COMPLETED | 49 |
| NOT COMPLETED | 3 |
IGSC 20%, 24 Weeks
| Stage | IGIV-C 10% First, IGSC 20% Second |
|---|---|
| STARTED | 49 |
| COMPLETED | 42 |
| NOT COMPLETED | 7 |
Analysis population for the primary outcome, as defined in the registry: The PK population consisted of all subjects who received study drugs and had sufficient and valid total IgG concentration versus time data for either the IV or SC Phase to allow calculation of AUC0-τ,SC or AUC0-τ,IV (the primary PK endpoint).
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
Population: Baseline data were collected for 53 enrolled subjects.
| Characteristic | Unit | IGIV-C 10% First, IGSC 20% Second |
|---|---|---|
| Participants analysed | 53 | |
| Age, Categorical: <=18 years | Participants | 15 |
| Age, Categorical: Between 18 and 65 years | Participants | 33 |
| Age, Categorical: >=65 years | Participants | 5 |
| Age, Continuous | years | 36.8 (SD 21.36) |
| Sex: Female, Male: Female | Participants | 26 |
| Sex: Female, Male: Male | Participants | 27 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 5 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 48 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 3 |
| Race (NIH/OMB): Asian | Participants | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 |
| Race (NIH/OMB): White | Participants | 48 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as AUC in the IV Phase and SC Phases: Steady-state AUC of Total IgG Over a Regular Dosing Interval, measured over For intravenous infusion, predose, 0,1,3-16 hours and 1,2,3,5,7,14,21 or 28 days (2, 7, 21, or 28 days for pediatric subjects) post-dose and for subcutaneous infusion, pre-dose,1,3,4,5,7 days (3 and 7 days for pediatric subjects) post-dose.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | 90% Confidence Interval |
| Unit | h*mg/dL |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is steady-state AUC of total IgG over a regular dosing interval, reported as a geometric mean with a 90% confidence interval. AUC, or area under the concentration-time curve, represents total measured exposure across the interval rather than a concentration at a single sampling time. The registry specifies time-point schedules for measurements after intravenous and subcutaneous administration, with separate schedules noted for pediatric subjects.
In general, AUC is used in pharmacokinetic comparisons because it brings concentration measurements across time into one exposure summary. A trough concentration answers a different question: it describes the pre-dose concentration at the end of a dosing interval. AUC and trough can therefore provide complementary descriptions of exposure. Neither measure alone describes every aspect of an individual’s concentration profile.
The stated purpose was to determine a weekly subcutaneous dose producing steady-state AUC that was non-inferior to the exposure under the regularly administered intravenous dose. A non-inferiority interpretation requires a prespecified margin and an estimate of the between-phase contrast with appropriate uncertainty. The margin, actual geometric means, confidence intervals, and reported endpoint result are not reported in the registry record. Consequently, the endpoint’s intended role can be described, but its numerical result and whether it met the stated objective cannot be assessed from the registry information available.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a pharmacokinetic study designed to compare steady-state total IgG exposure between an intravenous phase and a subcutaneous phase. It reports the endpoint definition, an analysis method, and phase-specific counts used in the PK analysis. It does not report the numerical AUC estimates or their 90% confidence intervals. Without those values, the magnitude and precision of the observed exposure cannot be described, and no conclusion about the stated non-inferiority objective can be drawn from the registry record.
The distinction between a study objective and a result is important. The record says the study was designed to identify a subcutaneous dose producing AUC non-inferior to the intravenous dose. That statement describes the research question, not proof that the criterion was met. The non-inferiority margin and the analysis result needed to evaluate that criterion are not reported in the registry record. The study’s title, completed status, and Phase 3 designation do not substitute for endpoint estimates or uncertainty intervals.
The design also shapes interpretation. The phases were sequential and allocation was non-randomized, with no masking. Thus, any phase contrast is not a randomized comparison between concurrent treatment groups. A numerical difference, if available, would need to be understood in the context of this design, the phase-specific data available, and the analysis model. The record does not describe adjustment for period or sequence effects, or other design features that might affect comparability. These details are not reported in the registry record.
The analysis counts differ by phase: the registry says that 49 subjects contributed PK data in the IV phase and 39 in the SC phase. Those counts alone do not tell the reader why the analysis populations differ, whether data were missing, or how any missing measurements were handled. The PK population required sufficient and valid concentration-time data to calculate the endpoint for either phase. Details about exclusions, missingness, and any sensitivity analyses are not reported in the registry record.
Safety counts are reported separately. Serious adverse events affected 1 of 52 subjects at risk in the IGIV-C 10% group and 2 of 49 at risk in the IGSC 20% group; deaths were reported as 0 in both groups. These are descriptive counts, not a randomized estimate of comparative risk. The record also reports other adverse events affecting 6 of 52 and 35 of 49, respectively. The groups’ sequential, non-randomized structure and the absence of detailed event context limit direct comparisons. Event severity, timing, exposure duration by group, and attribution beyond the reported categories are not given in the registry record.
Overall, the record supports a description of the study’s question, design, analysis population, and selected safety counts. It does not provide the primary PK outcome values needed to assess exposure or precision. Statistical interpretation should therefore distinguish the intended non-inferiority assessment from evidence of its result and should avoid treating the safety counts as a causal treatment comparison.
9. Statistical Methods Explained
The registry identifies analysis of variance (ANOVA) as the method used for the primary pharmacokinetic endpoint. It describes the endpoint as steady-state AUC of total IgG over a regular dosing interval, expressed as a geometric mean with a 90% confidence interval. The analysis used PK data from 49 subjects in the IV phase and 39 subjects in the SC phase. The registry does not report the model specification or the numerical estimates and intervals.
What does AUC measure?
In general, the area under a concentration-time curve summarizes measured concentrations across a period of time. Rather than focusing on one blood draw, it represents accumulated exposure over the dosing interval. The registry’s sampling schedules span different time points after each route of administration, with specified pediatric schedules. This endpoint is relevant to the study’s stated objective because the objective concerns steady-state total IgG exposure across a regular dosing interval.
AUC does not mean that every individual has the same concentration profile, and a group summary does not show each participant’s response. The geometric mean is a summary on a multiplicative scale and is often used when exposure measurements are positively skewed. That is a general statistical rationale; the registry does not report the distribution of the AUC data or its justification for selecting this summary.
What does a confidence interval convey?
In general, a confidence interval describes uncertainty around an estimated quantity under the assumptions of the analysis. A narrower interval indicates greater precision than a wider interval, while the interval’s position relative to a clinically or scientifically defined threshold is needed for some decisions. The registry specifies a 90% confidence interval for the AUC summary, but its bounds are not reported in the registry record. The interval’s width and location therefore cannot be interpreted.
For a non-inferiority assessment, the estimate and its uncertainty must be considered against a prespecified non-inferiority margin. The margin defines how much loss relative to the comparator would be acceptable for the study’s objective. This is a general explanation of the method, not a statement about the margin used in this trial. The margin and the numerical comparison are not reported in the registry record, so the criterion cannot be independently assessed.
Why is the design relevant to ANOVA?
ANOVA is a general method for comparing means across groups or conditions under a specified model. The registry reports that ANOVA was used, but it does not report the factors included, the exact outcome scale used in the model, any covariates, or the treatment of within-subject measurements. Those are important details because a model’s assumptions and structure should reflect how observations were collected. It would be inappropriate to infer a particular model from the word ANOVA alone.
The study is described as sequential and non-randomized, and as having no masking. This means the phase comparison is not based on randomized assignment to concurrent groups. General statistical reasoning suggests that phase order and time can matter in a sequential design; whether and how the analysis addressed such concerns is not reported in the registry record. No adjustment strategy should be assumed.
How should the analysis population be read?
The registry defines the PK population by study-drug receipt and the availability of sufficient, valid total IgG concentration-versus-time data to calculate the endpoint in either phase. This is an endpoint-specific analysis population, not necessarily the same as all enrolled subjects. The reported phase counts are 49 for IV and 39 for SC. The record does not say how many subjects contributed to both phases, why some participants were not included in a phase analysis, or whether exclusions were decided before results were examined.
Missing-data methods matter when data are unavailable or invalid. In general, excluding participants with insufficient measurements can affect the analysis if inclusion is related to exposure, outcome, or other characteristics. The registry does not report the extent or reasons for missing data, imputation, sensitivity analyses, or an assessment of whether missingness could affect conclusions. These points remain unresolved rather than implying that a particular bias occurred.
What can planning calculations say?
Planning illustrations based on an observed effect are not the original sample-size justification and are not observed power. In general, a sample-size calculation describes the number of participants that might be needed under stated assumptions about an effect, variability, significance level, allocation, and analysis. If assumptions differ from the true setting, the illustration may not reflect actual precision or design requirements. The registry’s original sample-size justification and its rationale are not reported in the registry record.
The registry entries describing the planning approach specify a two-sided significance level of 0.05, equal allocation, a normal approximation, and effect fractions for illustrative planning. These assumptions do not establish that the trial used those design choices: the trial itself was non-randomized and sequential. Planning numbers should therefore be read only as conditional illustrations, not as evidence that the study was adequately powered or that a result was statistically conclusive.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a primary AUC endpoint and a secondary outcome for mean steady-state pre-dose total IgG concentration after either route. It reports two outcome measures and one analysis. The numerical results for these outcomes are not reported in the registry record. The record does not describe a multiplicity-control strategy, a hierarchy among secondary outcomes, or whether any other endpoints were tested. It is therefore not possible to determine how the family of analyses was handled or whether any reported inference was adjusted for multiple comparisons.
Missing-data information is also limited. The PK population required receipt of study drugs and sufficient, valid concentration-versus-time data to calculate AUC in either phase. The registry gives 49 subjects for the IV-phase PK data and 39 for the SC-phase PK data, but does not report the reasons for the different phase counts, the number of incomplete measurements, or the disposition of all enrolled subjects by analysis. It does not state whether missing observations were imputed, excluded, or addressed through sensitivity analyses.
Analysis-population definitions matter because results can depend on which observations are included. In general, restricting an analysis to participants with usable data may affect interpretation if the availability of data is related to participant characteristics or outcomes. This is a general methodological consideration, not evidence that such a relationship occurred in this study.
The registry also does not report a protocol-level statistical analysis plan, the timing of analysis decisions, interim analyses, or rules for handling protocol deviations. Those details are not reported in the registry record and should not be inferred from the endpoint description or the completed status.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| IGIV-C 10% | 1 | 52 | 1.9% |
| IGSC 20% | 2 | 49 | 4.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| IGIV-C 10% | 0 of 52 |
| IGSC 20% | 0 of 49 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 5% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| IGIV-C 10% | 6 of 52 |
| IGSC 20% | 35 of 49 |
Most frequent serious adverse event terms
| Event term | Organ system | IGIV-C 10% | IGSC 20% |
|---|---|---|---|
| Sepsis | Infections and infestations | 1 of 52 | 1 of 49 |
| Pneumonia bacterial | Infections and infestations | 1 of 52 | 0 of 49 |
| Animal bite | Injury, poisoning and procedural complications | 0 of 52 | 1 of 49 |
| Cellulitis | Infections and infestations | 0 of 52 | 1 of 49 |
| Intervertebral disc | Musculoskeletal and connective tissue disorders | 0 of 52 | 1 of 49 |
Most frequent non-serious adverse event terms
| Event term | Organ system | IGIV-C 10% | IGSC 20% |
|---|---|---|---|
| Sinusitis | Infections and infestations | 3 of 52 | 9 of 49 |
| Infusion site nodule | General disorders | 0 of 52 | 6 of 49 |
| Bronchitis | Infections and infestations | 2 of 52 | 3 of 49 |
| Upper respiratory tract infection | Infections and infestations | 0 of 52 | 5 of 49 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 52 | 3 of 49 |
| Infusion site bruising | General disorders | 0 of 52 | 3 of 49 |
| Infusion site pain | General disorders | 0 of 52 | 3 of 49 |
| Pharyngitis streptococcal | Infections and infestations | 0 of 52 | 3 of 49 |
| Diarrhoea | Gastrointestinal disorders | 0 of 52 | 3 of 49 |
Serious events with the highest arm-level rate: sepsis (2.0%), animal bite (2.0%), cellulitis (2.0%), intervertebral disc (2.0%), pneumonia bacterial (1.9%).
The registry reports serious adverse events for subjects at risk in each treatment group: 1 of 52 in the IGIV-C 10% group and 2 of 49 in the IGSC 20% group. It reports 0 deaths in each group. These figures are counts of affected subjects and should be read descriptively. They do not, by themselves, establish a difference in safety between routes or show that an event was caused by a treatment.
The record also reports other adverse events affecting 6 of 52 subjects in the IGIV-C 10% group and 35 of 49 in the IGSC 20% group. The registry’s sequential, non-randomized design means these group counts are not a randomized, concurrent comparison. The record does not provide enough detail to determine how exposure time, event collection, event severity, or participant-level overlap affected the counts. No rate comparison should be inferred from the counts alone.
The serious-event terms listed include Sepsis, Animal bite, Cellulitis, Intervertebral disc, and Pneumonia bacterial, each with a reported percentage. The registry information does not specify in the listed data which group each term belongs to, so the terms should not be assigned to a treatment group. The percentages are reproduced as reported and should not be treated as comparative risks.
12. What the Result Does, and Does Not, Mean
The study asks a focused pharmacokinetic question: whether a weekly subcutaneous dose of IGSC 20% could produce steady-state total IgG exposure non-inferior to regularly administered intravenous IGIV-C 10% in subjects with primary immunodeficiency. It also includes a comparison of trough concentrations and an assessment of safety and tolerability. These aims identify what the trial was designed to investigate; they are not findings in themselves.
The registry record does not report the primary AUC estimates, their 90% confidence intervals, the non-inferiority margin, or the endpoint conclusion. As a result, it is not possible from these registry entries to say how the observed exposure compared between phases, how precisely it was estimated, or whether a non-inferiority criterion was met. The numerical trough results are also not reported in the registry record.
The record does give safety counts and the numbers at risk. Those figures provide a limited descriptive account of affected subjects and deaths. They do not establish causation or a comparative safety effect, particularly given the non-randomized, sequential design. The event terms and percentages also lack group attribution in the listed information.
In general, a non-inferiority conclusion depends on both the estimate and its uncertainty in relation to a prespecified margin. A finding of non-inferiority would not mean that two treatments are identical; it would mean that the analysis met a defined criterion for excluding an unacceptable loss, under the assumptions and design used. That general distinction cannot be applied to this trial’s result without its margin and outcome estimates, which are not reported in the registry record.
The available information supports understanding the design, intended endpoint, analysis population, and selected safety counts. It does not support claims about the magnitude of pharmacokinetic differences, precision of the primary result, or whether the study achieved its stated objective. The completed status alone does not fill those gaps.
13. Why This Trial Matters Statistically
This trial is statistically notable because it frames a route-of-administration question through pharmacokinetic exposure rather than relying only on a single concentration measurement. AUC summarizes total IgG exposure over a regular dosing interval, while a pre-dose trough describes concentration at a specific point in that interval. In general, those measures capture related but distinct features of a concentration-time profile.
The study’s non-inferiority objective also illustrates why an objective cannot be interpreted without its decision framework. A non-inferiority margin must define the acceptable limit, and the estimated contrast must be considered with its uncertainty. The registry record does not report the margin or AUC result, so the central statistical question cannot be resolved from the available information. This is a useful reminder to distinguish protocol intent from reported evidence.
Design is equally important. The study was open-label, non-randomized, and sequential, rather than a randomized comparison of concurrent groups. These characteristics do not invalidate descriptive pharmacokinetic observations, but they change how a contrast should be interpreted. Randomization is one way to support comparability; it was not used. The registry does not describe the full analysis model or how potential period effects were handled.
The analysis population also highlights that enrollment and endpoint analysis are not synonymous. Although enrollment was 53, the reported PK data counts were 49 in the IV phase and 39 in the SC phase, under a definition requiring sufficient and valid concentration-time data. Knowing the analysis population is essential, but the reasons for phase-specific inclusion and the treatment of missing data are not reported in the registry record.
Finally, the safety data demonstrate why raw group counts require design context. Counts of affected subjects and deaths can describe what was recorded, but they do not establish cause or comparative risk. Together, these features make the record useful for understanding the statistical question and its limits, while underscoring the need for endpoint estimates and analysis details before drawing conclusions.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The principal limitation of the registry information is that it does not report the numerical primary endpoint results. Although the AUC outcome and its 90% confidence interval are specified, the geometric means, interval bounds, and comparison are not reported in the registry record. The non-inferiority margin is also not reported, preventing assessment of the stated objective.
The study design was open-label, non-randomized, and sequential. It does not provide a randomized, concurrent comparison of the two routes. The registry does not report details sufficient to assess the impact of phase order, timing, or other potential differences between phases. It also does not state how any such considerations entered the ANOVA.
The analysis population required valid, sufficient concentration-time data, with 49 subjects in the IV phase and 39 in the SC phase. The reasons for the phase-specific counts, participant flow by phase, extent of missing measurements, and missing-data methods are not reported in the registry record. The record also does not report sensitivity analyses or other checks of robustness.
The statistical description is brief. ANOVA is named, but the model terms, assumptions, covariates, handling of repeated or paired observations, and analysis scale are not reported. The original sample-size justification is not reported in the registry record. Any planning illustration based on an observed effect should not be mistaken for the original design or for observed power.
Safety counts are limited by the same design context and by the level of detail available. The record does not provide the event timing, exposure duration, attribution, or group assignment for the listed serious-event terms. The counts therefore support description, not a causal or definitive comparative safety interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Pharmacokinetics of IGSC 20% in Subjects With Primary Immunodeficiency — NCT02604810.
- Registry record last updated 2019-10-04; status last verified 2018-09.
- Results first posted 2019-10-04.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
NCT02604810 is a completed Phase 3, open-label, multi-center, non-randomized, sequential study of IGSC 20% in subjects with primary immunodeficiency. Enrollment was 53. The study compared pharmacokinetic exposure during an IV phase using IGIV-C 10% and an SC phase using IGSC 20%, with a stated objective of evaluating non-inferiority of steady-state total IgG AUC.
The primary endpoint was steady-state AUC over a regular dosing interval, summarized as a geometric mean with a 90% confidence interval. ANOVA was reported, using PK data from 49 subjects in the IV phase and 39 in the SC phase. The numerical AUC results, confidence intervals, non-inferiority margin, and conclusion are not reported in the registry record.
Serious adverse events affected 1 of 52 subjects at risk in the IGIV-C 10% group and 2 of 49 in the IGSC 20% group; deaths were 0 in both groups. These descriptive counts do not establish a causal or randomized safety comparison.