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 Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients (NCT03359850), a non-randomized phase 1 study. The primary outcome is Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Niraparib and Its Major Metabolite (M1) During PK Phase.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03359850 |
| Phase | Phase 1 |
| Condition | Ovarian Neoplasms, Neoplasms, Solid Tumor |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 17 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Tesaro, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with advanced solid tumors and either normal hepatic function or moderate hepatic impairment. The registry record reports enrollment of 17 participants. The pharmacokinetic population was defined as participants who received niraparib and had sufficient evaluable samples.
Intervention
A single oral dose of niraparib, with pharmacokinetic sampling before dosing and at scheduled times after dosing on Day 1. The record also describes an extension phase, but does not give further details about its treatment schedule.
Comparator
The groups were participants with normal hepatic function and participants with moderate hepatic impairment. Allocation was non-randomized, so the groups were not designed as randomized, like-for-like controls. The record does not report a formal adjusted comparison between them.
Primary question
What are the plasma exposure measures for niraparib and its major metabolite, M1, after dosing, as measured by area under the concentration-time curve from time 0 to the last quantifiable concentration? The registry record does not report the numerical endpoint results.
The study asks a pharmacokinetic question: whether exposure to niraparib and M1 can be characterized in participants with moderate hepatic impairment, alongside measurements in participants with normal hepatic function. This is not a trial of clinical benefit or a randomized comparison of treatment strategies. Its stated purpose is to evaluate pharmacokinetics and safety in the two hepatic-function groups, with the aim of informing recommendations about initial dosing and dose titration in the impaired-function population.
The record identifies advanced solid tumors as the clinical setting and lists ovarian neoplasms, neoplasms, solid tumor, and hepatic impairment among the conditions. It describes the study as open-label, non-randomized, multicenter, and based on a single oral dose for the pharmacokinetic evaluation. The endpoint focuses on measured drug exposure, not tumor response, survival, or a patient-reported outcome. Numerical exposure results and a registry-reported estimate of the difference between groups are not reported in the registry record.
3. Trial Design
This was a Phase 1, open-label, non-randomized, multicenter study with a parallel-group model. The registry record lists an enrollment of 17 and a completed status. The study start date was 2018-02-20, and the primary completion date was 2019-09-16. Participants were assigned to groups according to hepatic function rather than randomly allocated: one group had normal hepatic function and the other had moderate hepatic impairment.
Both groups received niraparib. The primary pharmacokinetic assessment followed a single oral dose, with blood collection before dosing and at scheduled post-dose times on Day 1. The listed times extend from 1 hour to 168 hours after dosing, with a pre-dose sample. Pharmacokinetic parameters were calculated using standard non-compartmental analysis, according to the endpoint description. The record also separates adverse-event reporting into a pharmacokinetic phase and an extension phase. It does not report the extension-phase treatment schedule or enough detail to infer how participants entered that phase.
Because allocation was non-randomized, hepatic-function groups may differ in other characteristics. The comparison is therefore descriptive and pharmacokinetic rather than a randomized estimate of a treatment effect. No formal statistical analysis results are reported in the registry record. Although the record lists 32 outcome measures, it does not provide numerical results for the primary pharmacokinetic endpoint. The rationale for the enrollment target, the detailed eligibility criteria, the planned statistical analysis, and the conduct of any interim analyses are not reported in the registry record.
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: This is a 2 period study including pharmacokinetic (PK) phase and extension (Ext.) phase. A total of 17 participants were enrolled in the study and received study treatment, niraparib.
PK Phase (Up to Day 8)
| Stage | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| STARTED | 9 | 8 |
| COMPLETED | 8 | 7 |
| NOT COMPLETED | 1 | 1 |
Reasons for not completing this period:
| Reason | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Physician Decision | 0 | 1 |
| Adverse Event | 1 | 0 |
Extension Phase (Up to 28 Months)
| Stage | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| STARTED | 8 | 7 |
| COMPLETED | 0 | 1 |
| NOT COMPLETED | 8 | 6 |
Reasons for not completing this period:
| Reason | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function |
|---|---|---|
| Death | 2 | 4 |
| Withdrawal by Subject | 1 | 2 |
| Disease Progression | 5 | 0 |
Analysis population for the primary outcome, as defined in the registry: PK population consisted of all participants who have received niraparib and have sufficient evaluable samples
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.
| Characteristic | Unit | Participants With Normal Hepatic Function | Participants With Impaired Hepatic Function | Total |
|---|---|---|---|---|
| Participants analysed | 9 | 8 | 17 | |
| Age, Continuous | Years | 64.8 (SD 6.69) | 63.6 (SD 7.71) | 64.2 (SD 6.98) |
| Sex: Female, Male: Female | Participants | 2 | 4 | 6 |
| Sex: Female, Male: Male | Participants | 7 | 4 | 11 |
| Race/Ethnicity, Customized: Black or African American | Participants | 1 | 0 | 1 |
| Race/Ethnicity, Customized: White | Participants | 8 | 8 | 16 |
6. Primary Endpoint
The registry lists the primary outcome as Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Niraparib and Its Major Metabolite (M1) During PK Phase, measured over Pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 120, 168 hours post dose Day 1.
| Element | Registry entry |
|---|---|
| Result type | Geometric Mean |
| Measure of spread | Geometric Coefficient of Variation |
| Unit | Hour*nanogram per milliliter (hr*ng/mL) |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is the area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration, abbreviated AUClast, for niraparib and its major metabolite M1. It is expressed in hour*nanogram per milliliter (hr*ng/mL). The endpoint description states that blood samples were collected at scheduled times and that pharmacokinetic parameters were calculated by standard non-compartmental analysis.
In general, an area-under-the-curve measure summarizes drug concentration across the period covered by the sampling. AUClast uses the last concentration that can be quantified, so its interpretation depends on the observed concentration profile and the sampling schedule. It is an exposure measure, not a direct measure of clinical benefit or harm. The record identifies the reported summary as a geometric mean with geometric coefficient of variation as its dispersion measure. In general, a geometric mean is useful for positive measurements that may be right-skewed, while a geometric coefficient of variation describes relative variability on a multiplicative scale.
The record does not report the group-specific AUClast geometric means or geometric coefficients of variation for niraparib or M1. It also does not report a numerical ratio or other formal estimate comparing hepatic-function groups. Consequently, the endpoint definition can be described, but the magnitude and precision of the observed exposure cannot be assessed from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record establishes what the primary pharmacokinetic question was, but does not provide the numerical results needed to answer it. It names AUClast for niraparib and M1 as the primary endpoint, specifies geometric means and geometric coefficients of variation, and describes the sampling schedule. It does not report the actual endpoint values by hepatic-function group, an estimated between-group contrast, or a confidence interval. The size and precision of any exposure difference therefore cannot be characterized from the registry record.
The posted safety counts are descriptive. In the pharmacokinetic phase, the record lists 1 participant with a serious adverse event among 9 participants with normal hepatic function, and 0 among 8 participants with impaired hepatic function. For other adverse events, it lists 5 among 9 and 3 among 8, respectively. In the extension phase, it lists 3 participants with serious adverse events among 8 with normal hepatic function and 2 among 7 with impaired hepatic function; other adverse events are listed for 8 of 8 and 7 of 7, respectively. The record also lists deaths in the extension phase: 2 in the normal-function group and 4 in the impaired-function group. These are reported counts, not randomized comparative estimates, and the record does not provide a causal analysis of them.
The pharmacokinetic and extension-phase safety counts should not be treated as a single undifferentiated follow-up summary. The registry presents them by phase, and the numbers at risk differ between groups and phases. It does not report why participants were not included in each phase's at-risk count, or how the extension participants relate to the original enrollment beyond the group labels. The available counts therefore support a description of what was recorded in each phase, but not a reconstruction of individual participant pathways or exposure-adjusted event rates.
The record lists several serious adverse-event terms with percentages, including abdominal pain and sepsis at 14.3%, and pyrexia, musculoskeletal pain, and intestinal obstruction at 12.5%. It does not identify the denominator or state whether participants could contribute to more than one term in that list. Those percentages should not be converted into event counts or compared across groups without that context. More broadly, a small, non-randomized study can describe observed pharmacokinetics and safety, but it cannot by itself separate hepatic-function effects from other differences between groups. No uncertainty intervals for the safety counts are reported in the registry record.
9. Statistical Methods Explained
What does the primary endpoint summarize?
In general, pharmacokinetic analysis describes how drug concentrations change over time after administration. The primary endpoint is AUClast, the area under the plasma concentration-time curve from time 0 through the last quantifiable concentration. It summarizes measured exposure across the observed portion of the concentration profile. It does not, by itself, describe clinical efficacy, toxicity, or the reason for any concentration difference.
The endpoint description says that samples were collected before dosing and at scheduled times through 168 hours after the single oral dose on Day 1. It states that the pharmacokinetic parameters were calculated using standard non-compartmental analysis. In general, non-compartmental analysis derives pharmacokinetic measures from the observed concentration-time data without requiring a specified compartment model. The registry record does not give the individual concentration data, the handling of values below quantification limits, or the detailed computational choices used for these calculations.
Why report geometric summaries?
The record names the geometric mean as the summary for AUClast and the geometric coefficient of variation as the measure of dispersion. In general, exposure measures are positive and may have a skewed distribution. A geometric mean describes the central value on a multiplicative scale, while a geometric coefficient of variation expresses relative spread around that scale. These summaries do not convey the full distribution, and the coefficient of variation is not a confidence interval. A confidence interval, in general, expresses the uncertainty around an estimate under a specified statistical model; no confidence interval for the primary endpoint is reported in the registry record.
What does the group comparison allow?
The two groups are defined by hepatic function and were not randomized. In general, randomization helps balance both measured and unmeasured characteristics across groups. Without random allocation, observed differences in exposure may reflect hepatic function, other participant characteristics, or a combination of factors. The registry record does not report an adjusted model, matching procedure, or formal inferential comparison, so the groups should be read descriptively rather than as equivalent control arms.
The study is described as parallel, meaning the record presents distinct groups rather than a crossover sequence in which each participant receives conditions in turn. The group descriptions specify normal hepatic function and moderate hepatic impairment. The record does not report enough detail to establish the specific criteria used to assign or classify hepatic function, or whether other disease or medication characteristics were controlled in the analysis.
How should adverse-event counts be understood?
The adverse-event results distinguish serious adverse events from other adverse events and separate the pharmacokinetic phase from the extension phase. In general, a participant count for an adverse-event category is different from a count of all event episodes: one participant may experience more than one event. The record presents counts of participants affected and the numbers at risk for each group and phase. It does not provide event-level timing, duration, severity grades, exposure-adjusted rates, or a statistical comparison. Thus the counts describe the registry categories, not the rate of events per unit of exposure or evidence that one group had a higher underlying risk.
The serious-event term list includes percentages, but the registry record does not state the denominator for those percentages or clarify whether the list is based on participants or event episodes. In general, percentages are only interpretable when their denominator and counting rules are clear. They should not be combined with the group-specific counts to infer a group rate when the relevant linkage is not reported.
What is missing from the analysis record?
The registry record lists 32 outcome measures but reports 0 analyses. It does not report numerical AUClast results, confidence intervals, p-values, or a prespecified inferential model. The sample-size justification, planned power, analysis of missing pharmacokinetic samples, and multiplicity strategy are not reported in the registry record. This absence does not establish that no such work was conducted; it means that these details cannot be evaluated from the registry record.
In general, over-dispersion means that observed variability exceeds what a simpler statistical model expects. It can make standard errors and inferential results unreliable if the model does not account for that variability. The record does not report a model for the primary endpoint, so there is no basis for assessing whether over-dispersion was evaluated or how it would have been handled. Likewise, no estimate of the precision of the group contrast is available. The registry information supports a description of the intended pharmacokinetic assessment and the recorded safety counts, but not a reanalysis of the concentration data or a quantitative conclusion about comparative exposure.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 32 outcome measures, including the primary AUClast endpoint and secondary safety and laboratory measures. It does not report a multiplicity strategy, such as whether any outcomes were prioritized for formal hypothesis testing or whether adjustments were planned for multiple comparisons. Because numerical primary and secondary analysis results are not reported, the impact of any multiplicity approach cannot be assessed. The record does not report p-values for the pharmacokinetic endpoint.
Missing-data handling is also not reported in the registry record. The primary endpoint population is described as participants who received niraparib and had sufficient evaluable samples, but the record does not state how many participants met that definition, which samples were required, or how incomplete sampling was handled. It does not describe imputation, exclusions, or sensitivity analyses. These details matter in general because incomplete concentration-time profiles can affect the calculation and interpretation of an area-under-the-curve measure.
The registry specifies the pharmacokinetic population definition but does not report the number included in the primary analysis or provide a separate safety-analysis population definition. The adverse-event counts give the number at risk for each hepatic-function group and phase, but reasons for differences in those counts are not reported in the registry record. No intention-to-treat analysis is described, and the non-randomized design makes a randomized intention-to-treat comparison inapplicable as a straightforward interpretation.
The rationale for the enrollment of 17 participants, the statistical analysis plan, interim analyses, and any sample-size justification are not reported in the registry record. Consequently, it is not possible to assess whether the study was designed around a particular precision target for AUClast or to determine how the planned analyses addressed the several listed outcomes.
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 |
|---|---|---|---|
| Participants With Normal Hepatic Function-PK Phase | 1 | 9 | 11.1% |
| Participants With Impaired Hepatic Function-PK Phase | 0 | 8 | 0.0% |
| Participants With Normal Hepatic Function-Extension Phase | 3 | 8 | 37.5% |
| Participants With Impaired Hepatic Function-Extension Phase | 2 | 7 | 28.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Participants With Normal Hepatic Function-PK Phase | 0 of 9 |
| Participants With Impaired Hepatic Function-PK Phase | 0 of 8 |
| Participants With Normal Hepatic Function-Extension Phase | 2 of 8 |
| Participants With Impaired Hepatic Function-Extension Phase | 4 of 7 |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Participants With Normal Hepatic Function-PK Phase | 5 of 9 |
| Participants With Impaired Hepatic Function-PK Phase | 3 of 8 |
| Participants With Normal Hepatic Function-Extension Phase | 8 of 8 |
| Participants With Impaired Hepatic Function-Extension Phase | 7 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Participants With Normal Hepatic Function-PK Phase | Participants With Impaired Hepatic Function-PK Phase | Participants With Normal Hepatic Function-Extension Phase | Participants With Impaired Hepatic Function-Extension Phase |
|---|---|---|---|---|---|
| Influenza | Infections and infestations | 1 of 9 | 0 of 8 | 0 of 8 | 0 of 7 |
| Pneumonia | Infections and infestations | 1 of 9 | 0 of 8 | 0 of 8 | 0 of 7 |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | 1 of 9 | 0 of 8 | 0 of 8 | 0 of 7 |
| Pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | 1 of 9 | 0 of 8 | 0 of 8 | 0 of 7 |
| Abdominal pain | Gastrointestinal disorders | 0 of 9 | 0 of 8 | 0 of 8 | 1 of 7 |
| Pyrexia | General disorders | 0 of 9 | 0 of 8 | 1 of 8 | 0 of 7 |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 0 of 9 | 0 of 8 | 1 of 8 | 0 of 7 |
| Sepsis | Infections and infestations | 0 of 9 | 0 of 8 | 0 of 8 | 1 of 7 |
| Intestinal obstruction | Gastrointestinal disorders | 0 of 9 | 0 of 8 | 1 of 8 | 0 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Participants With Normal Hepatic Function-PK Phase | Participants With Impaired Hepatic Function-PK Phase | Participants With Normal Hepatic Function-Extension Phase | Participants With Impaired Hepatic Function-Extension Phase |
|---|---|---|---|---|---|
| Fatigue | General disorders | 0 of 9 | 1 of 8 | 7 of 8 | 5 of 7 |
| Anaemia | Blood and lymphatic system disorders | 0 of 9 | 0 of 8 | 3 of 8 | 5 of 7 |
| Nausea | Gastrointestinal disorders | 1 of 9 | 1 of 8 | 4 of 8 | 1 of 7 |
| Thrombocytopenia | Blood and lymphatic system disorders | 0 of 9 | 0 of 8 | 2 of 8 | 5 of 7 |
| Constipation | Gastrointestinal disorders | 0 of 9 | 0 of 8 | 4 of 8 | 3 of 7 |
| Decreased appetite | Metabolism and nutrition disorders | 0 of 9 | 1 of 8 | 2 of 8 | 3 of 7 |
| Abdominal pain | Gastrointestinal disorders | 0 of 9 | 0 of 8 | 2 of 8 | 3 of 7 |
| Aspartate aminotransferase increased | Investigations | 1 of 9 | 1 of 8 | 0 of 8 | 2 of 7 |
| Hyperbilirubinaemia | Hepatobiliary disorders | 0 of 9 | 2 of 8 | 0 of 8 | 2 of 7 |
| Vomiting | Gastrointestinal disorders | 1 of 9 | 0 of 8 | 1 of 8 | 2 of 7 |
Serious events with the highest arm-level rate: abdominal pain (14.3%), sepsis (14.3%), pyrexia (12.5%), musculoskeletal pain (12.5%), intestinal obstruction (12.5%).
Safety counts are reported separately for the pharmacokinetic and extension phases. During the pharmacokinetic phase, the record lists serious adverse events for 1 of 9 participants with normal hepatic function and 0 of 8 with impaired hepatic function. Other adverse events are listed for 5 of 9 and 3 of 8, respectively. During the extension phase, serious adverse events are listed for 3 of 8 participants with normal hepatic function and 2 of 7 with impaired hepatic function; other adverse events are listed for 8 of 8 and 7 of 7.
The record lists 0 deaths for each group in the pharmacokinetic phase, and 2 deaths in the normal-function group and 4 in the impaired-function group during the extension phase. These counts should be kept distinct by phase. The registry record does not report event timing, causes of death, exposure duration, or a causal assessment, so the counts alone cannot establish why events occurred or support a comparison of underlying risk.
In general, small group counts are sensitive to individual observations, and non-randomized groups may differ in ways that affect safety outcomes. The serious adverse-event term percentages are listed without a stated denominator, so they cannot be reliably translated into group-specific counts. All figures are descriptive registry entries, not estimates from a controlled safety comparison.
12. What the Result Does, and Does Not, Mean
The record describes a study designed to measure niraparib and M1 exposure after a single oral dose in participants with normal hepatic function or moderate hepatic impairment. It also reports adverse-event counts for the pharmacokinetic and extension phases. Those details establish the study's purpose and the types of outcomes recorded, but they do not provide the numerical primary pharmacokinetic results.
Without AUClast values for each group and a corresponding estimate of uncertainty, it is not possible to say how large or precise any observed exposure difference was. The record also does not report a formal comparison or adjusted analysis. The endpoint measures drug exposure over the observed sampling period; it does not directly establish clinical benefit, establish a dose recommendation, or demonstrate that a particular dose is appropriate for an individual.
The safety results should be interpreted as counts of participants with recorded events in the registry-defined groups and phases. The study was non-randomized, and its groups were defined by hepatic function. Differences in their counts cannot be attributed to hepatic function alone from these data. The record does not provide exposure-adjusted event rates, confidence intervals, or a causal assessment of the deaths listed in the extension phase.
In general, a Phase 1 pharmacokinetic study can contribute information about drug exposure and tolerability in a defined population. Whether those observations support a particular dosing recommendation requires the underlying results and an appropriate clinical and regulatory assessment. The registry record states that informing initial dose and dose titration was the study's purpose, but the numerical exposure results and resulting recommendations are not reported in the registry record. The appropriate reading is therefore limited to the design, endpoint definition, and descriptive safety counts that are actually recorded.
13. Why This Trial Matters Statistically
This study illustrates the distinction between a pharmacokinetic endpoint and a clinical outcome. AUClast summarizes measured drug exposure, while the listed safety outcomes describe adverse events and laboratory changes. These address different questions: exposure characterization does not itself establish clinical benefit or explain the cause of a safety event. Keeping those interpretations separate is important when reading early-phase studies.
The non-randomized design also matters statistically. Participants were grouped by hepatic function rather than randomly assigned, so differences between groups are not automatically attributable to hepatic function. A descriptive comparison can be useful for characterizing the observed data, but a causal interpretation would require additional design or analysis information not reported in the registry record.
The record provides useful details about the intended sampling schedule, endpoint summary, pharmacokinetic population definition, and safety reporting phases. At the same time, it does not provide the numerical primary endpoint results, uncertainty estimates, or analysis plan. This contrast shows why endpoint definitions and study design are not substitutes for results: readers need estimates and their precision to judge what the data indicate.
Finally, the separation between pharmacokinetic and extension phases is important when interpreting safety counts. The numbers at risk differ by phase, and the record does not explain those changes. Preserving the phase-specific context avoids treating counts from different follow-up periods as if they came from one common population and observation window.
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 most important limitation for statistical interpretation is that numerical results for the primary endpoint are not reported in the registry record. Group-specific geometric means, geometric coefficients of variation, a contrast between groups, and confidence intervals are unavailable. The registry record therefore does not allow the magnitude or precision of the pharmacokinetic findings to be assessed.
The non-randomized design limits causal interpretation of differences between participants with normal hepatic function and those with moderate hepatic impairment. The record does not report an adjusted analysis or the detailed participant characteristics needed to assess potential group differences. It also does not report the criteria used to classify hepatic impairment, beyond the group labels.
The enrollment was 17, and the record does not report the rationale for that target or a precision-based sample-size justification. It does not report the number included in the pharmacokinetic population, the handling of incomplete samples, or sensitivity analyses for missing data. The statistical analysis plan and multiplicity approach are not reported in the registry record.
Safety counts are divided by phase, with different numbers at risk across groups and phases. The record does not explain changes in those numbers, provide exposure-adjusted rates, or give a causal assessment of deaths. The listed serious-event term percentages have no stated denominator in the registry record. These limitations mean the event counts should be treated as descriptive and should not be interpreted as comparative risk estimates.
The extension-phase schedule, duration of follow-up, and relationship between participants in the pharmacokinetic and extension phases are not reported in the registry record. No conclusion about longer-term exposure or safety can be drawn from the phase labels alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Pharmacokinetic and Safety Study of Niraparib With Normal or Moderate Hepatic Impairment Patients — NCT03359850.
- Registry record last updated 2021-05-28; status last verified 2021-05.
- Results first posted 2020-11-16.
- 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
NCT03359850 is a completed Phase 1, open-label, non-randomized, multicenter study of niraparib in participants with advanced solid tumors and normal hepatic function or moderate hepatic impairment. The registry record lists enrollment of 17 and describes a single oral dose for the pharmacokinetic evaluation.
The primary endpoint was AUClast for niraparib and M1, summarized as a geometric mean with geometric coefficient of variation. The record describes scheduled blood sampling and standard non-compartmental analysis, but numerical primary endpoint results are not reported in the registry record.
Adverse-event counts are listed separately for the pharmacokinetic and extension phases. They are descriptive, and the registry record does not report a formal comparative safety analysis, an adjusted pharmacokinetic comparison, or the statistical plan. The study's stated purpose was to evaluate pharmacokinetics and safety in moderate hepatic impairment.