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 Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain (NCT02101554), a registered phase 4 study. The primary outcome is Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Week 1 to Week 4.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02101554 |
| Phase | Phase 4 |
| Condition | Moderate-severe Pain |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | None (open label) |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Children ages 7–17 with moderate-to-severe pain. The primary-outcome population is described as participants who were screened and received at least one dose of PF-06412528 during Week 1 to Week 4.
Intervention
PF-06412528, identified in the study title as EMBEDA. The registry lists age-group interventions for ages 7–11 and ages 12–17, and the safety results are organized by dose ranges.
Comparator
No comparator is reported. The arm description identifies one open-label active arm, and the registry does not describe a randomized control comparison.
Primary question
How many participants experienced treatment-emergent adverse events, including serious adverse events, during Week 1 to Week 4?
This is a safety and pharmacokinetic study, rather than a trial designed in the record as a comparative test of treatment against a control. The brief summary describes an abuse-deterrent, extended-release formulation of morphine sulfate with a sequestered naltrexone core. The formal study title describes evaluation of safety and pharmacokinetics in children ages 7–17 for treatment of moderate-to-severe pain.
The primary outcome is a participant count, not a measure of pain relief or a direct pharmacokinetic estimate. Secondary outcomes listed in the record include vital-sign criteria, laboratory abnormalities, apparent volume of distribution, and dose-exposure relationships for metabolites of morphine, naltrexone, and 6-β-naltrexol. The record therefore addresses several kinds of safety and drug-exposure questions, but the primary endpoint specifically tracks adverse-event occurrence during the stated treatment window.
Because the registry describes an open-label active arm and does not report a comparator, the central question is descriptive: what adverse events were recorded among participants receiving the study drug? The listed age groups and dose ranges provide context for the population and reported safety data, but the registry does not state that those groups were randomly assigned or intended as like-for-like comparisons.
3. Trial Design
The registry identifies this as a Phase 4, open-label study of PF-06412528 in children ages 7–17 with moderate-to-severe pain. Masking is listed as none. Enrollment is recorded as 19, and the study status is terminated. The registry gives a study start date of 2015-04-24 and a primary completion date of 2019-06-26. It does not report why the study was terminated.
The arm description identifies one open-label active arm. The interventions are listed by age group: ages 7–11 and ages 12–17. Separately, the posted adverse-event data are organized into PF-06412528 dose ranges of <=20 mg, >20-40 mg, and >40-80 mg. The record does not explain how age groups, treatment assignments, and dose ranges relate to one another, nor does it report an allocation method. The record notes that this is not a randomized comparison and that the arms are not a like-for-like control comparison.
The primary outcome is the number of participants with treatment-emergent adverse events and serious adverse events from Week 1 to Week 4. The outcome description defines an adverse event as an untoward medical occurrence after receiving study treatment, regardless of whether a causal relationship was considered possible. A treatment-emergent event is one that began during treatment after being absent beforehand, or worsened during treatment relative to the pretreatment state. Serious events include events associated with specified serious consequences or deemed significant for another reason.
The record lists 25 outcome measures, including secondary safety and pharmacokinetic outcomes. It lists no outcome analyses. Further details about the protocol, study procedures, dose assignment, follow-up beyond the primary endpoint timeframe, and reasons for termination 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.
Overall Study
| Stage | PF-06412528 <=20 mg | PF-06412528 >20-40 mg | PF-06412528 >40-80 mg |
|---|---|---|---|
| STARTED | 6 | 10 | 3 |
| COMPLETED | 3 | 5 | 2 |
| NOT COMPLETED | 3 | 5 | 1 |
Reasons for not completing this period:
| Reason | PF-06412528 <=20 mg | PF-06412528 >20-40 mg | PF-06412528 >40-80 mg |
|---|---|---|---|
| Protocol Violation | 0 | 1 | 0 |
| Insufficient Clinical Response | 0 | 2 | 0 |
| Adverse Event | 2 | 1 | 1 |
| Lost to Follow-up | 0 | 1 | 0 |
| Withdrawl by Parents/Guardians | 1 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Analysis population included all participants who were screened and had received at least 1 dose of PF-06412528 from Week 1 to Week 4.
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: Safety analysis population included all participants who received at least 1 dose of PF-06412528.
| Characteristic | Unit | PF-06412528 <=20 mg | PF-06412528 >20-40 mg | PF-06412528 >40-80 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 6 | 10 | 3 | 19 | |
| Age, Continuous | years | 14.3 (SD 2.34) | 15.0 (SD 1.33) | 15.3 (SD 1.53) | 14.8 (SD 1.68) |
| Sex: Female, Male: Female | Participants | 3 | 7 | 3 | 13 |
| Sex: Female, Male: Male | Participants | 3 | 3 | 0 | 6 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 4 | 4 | 0 | 8 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 2 | 6 | 3 | 11 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Asian | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Black or African American | Participants | 2 | 2 | 2 | 6 |
| Race (NIH/OMB): White | Participants | 3 | 7 | 1 | 11 |
| Race (NIH/OMB): More than one race | Participants | 1 | 1 | 0 | 2 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs): Week 1 to Week 4, measured over Week 1 to Week 4.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts participants with treatment-emergent adverse events and serious adverse events during Week 1 to Week 4. Its unit is participants. It combines serious and non-serious adverse events in the overall endpoint description, while the posted safety results distinguish serious events from other adverse events within dose groups.
An adverse event is defined in the record as an untoward medical occurrence in someone who received treatment, whether or not a causal relationship to the study drug was considered possible. The treatment-emergent definition focuses on events that newly appear during treatment or worsen relative to the pretreatment state. This timing helps distinguish events occurring during treatment from events already present without worsening, but it does not by itself establish that treatment caused an event.
Serious adverse events are a defined subset, including events resulting in death, initial or prolonged inpatient hospitalization, a life-threatening experience, persistent or significant disability or incapacity, or congenital anomaly, as well as events considered significant for another reason. This distinction matters because seriousness refers to the event’s consequences or significance, not simply its intensity.
Counting participants with an event is a useful descriptive safety measure: it communicates how many people were affected within the recorded population and timeframe. It does not capture every detail of event duration, recurrence, severity, or relationship to treatment. The endpoint is not a measure of efficacy, and it does not estimate pharmacokinetic exposure. Those topics appear in the study purpose and secondary outcomes, but the primary outcome is the participant count for adverse events over Week 1 to Week 4.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted results report serious adverse events in each of the three listed dose groups: 2 participants among 6 at risk in the <=20 mg group, 2 among 10 in the >20-40 mg group, and 2 among 3 in the >40-80 mg group. Other adverse events are also reported in each group: 5 participants among 6 at risk, 9 among 10, and 3 among 3, respectively. These are descriptive counts within the recorded dose categories, not estimates from a randomized comparison.
The record also lists serious-event terms with percentages. Sickle cell anaemia with crisis, pyrexia, pneumonia, bone infarction, and acute respiratory distress syndrome are each listed as 33.3%; abdominal pain is listed as 16.7%. The registry excerpt does not specify the denominator or counting convention for these term percentages, so they should not be read as incidence estimates for the full study population without that context. The count of participants with serious events is not interchangeable with a count of event episodes or distinct event types.
Zero deaths are recorded in each of the three dose groups. This describes the posted group entries and does not provide information about causes of other serious events. The results do not state whether events were judged related to treatment, how long events lasted, or whether participants had multiple events. Although the endpoint definition says that causal relationship is not required for an event to qualify, the record excerpt does not provide event-by-event causality assessments.
These dose-group figures should not be interpreted as evidence that higher doses caused more or fewer events. The registry does not report random allocation, a concurrent control group, or a statistical comparison among dose categories. The group counts are limited in size, and the record does not provide confidence intervals for these displayed figures. In general, uncertainty around an estimate is important when interpreting small groups; a count alone does not show how precisely the underlying event frequency is known.
The primary endpoint timeframe is Week 1 to Week 4. The available summary does not establish what happened outside that window, whether all participants completed the same period of observation, or how missing safety follow-up was handled. Nor does it provide numerical results for the listed pharmacokinetic outcomes. The registry status is terminated, but the reason for termination is not reported in the registry record, so status alone cannot explain the observed counts or the scope of the results.
Overall, the posted data describe adverse-event counts across dose categories in an open-label pediatric study. They do not establish comparative safety against an untreated or active control group, demonstrate causation, or answer whether pain improved. The numerical information supports a descriptive reading of the observed safety reports, with important uncertainty about comparison, event attribution, and completeness of follow-up.
9. Statistical Methods Explained
What does a participant count tell the reader?
The primary outcome is a count of participants with treatment-emergent adverse events and serious adverse events. A count is direct and interpretable: it identifies how many participants in a stated group met the outcome definition during the specified observation period. The posted dose-group results give both the number at risk and the number affected for serious events and other events. Reading the count together with its group denominator gives context for the observed frequency, without implying that the group is representative of a broader population.
A participant count is different from an event count. One participant may experience more than one event, and a participant may have events in more than one category. The registry record does not provide enough detail in this summary to reconstruct event episodes, recurrence, or overlap between terms. The listed serious-event term percentages should therefore be read as the registry’s reported term entries, rather than converted into participant counts or treated as independent events.
Why distinguish serious from other adverse events?
Seriousness is defined by consequences or clinical significance, including death, hospitalization, immediate risk of dying, persistent or significant disability or incapacity, or congenital anomaly. It is not simply another word for severity. The results present serious adverse events separately from other adverse events, allowing those categories to be considered distinctly. The endpoint definition also states that adverse events include both serious and non-serious events.
The treatment-emergent definition uses change over time: an event qualifies if it begins during treatment after being absent before treatment, or worsens during treatment compared with pretreatment status. In general, this definition is intended to focus analysis on events that arise or change during the exposure period. It does not prove the treatment caused the event. The outcome description explicitly says that an event qualifies without regard to the possibility of a causal relationship.
What can be inferred from the dose-group entries?
The reported dose categories are descriptive groupings. The registry does not report allocation, randomization, or a dose-comparison analysis. In general, an observed difference between groups can reflect the way participants entered or received treatment, as well as chance and other differences between groups. Without a stated design supporting direct comparisons, the counts should not be treated as evidence of a dose-response relationship.
Likewise, the ages 7–11 and 12–17 appear as intervention labels, while the adverse-event results are displayed by dose range. The record does not report how these groupings map to one another or whether the age strata were analyzed separately. A reader should not infer that the dose groups are age-matched, mutually comparable, or randomly assigned.
How should uncertainty be considered?
In general, a confidence interval describes a range of values compatible with the observed data under the assumptions of a statistical method. It communicates precision as well as the observed estimate; wider intervals indicate greater uncertainty. No confidence intervals for the adverse-event counts are reported in the registry record. The displayed counts, particularly within the dose categories, should therefore be understood as descriptive observations rather than highly precise estimates of event frequency.
A significance test would address a specified comparison and statistical hypothesis. The registry lists no outcome analyses, and it does not report a planned hypothesis test for comparing dose groups. No p-value or inferential conclusion should be read into the counts. In general, failure to report a test is not evidence that groups are equivalent; equivalence requires an appropriate design and analysis, neither of which is described.
What is the role of the planning illustration?
The sample-size illustration is based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. It considers planning for a stated fraction of the observed effect. This is a planning exercise, not an account of the study’s actual design or an observed measure of power. The registry does not report that these assumptions were used to plan this trial, and the study is not described as a randomized two-arm comparison. The illustration should not be used to imply that the trial had a particular probability of detecting an effect.
In general, power is a property calculated under specified assumptions about the design, effect, variability, and analysis. It is not a probability that the observed result is true. A sample-size calculation based on an observed effect is especially dependent on that effect estimate and its uncertainty. The registry record does not provide a sample-size justification or a prospective statistical plan for this study.
What does the registry not explain?
The registry records 25 outcome measures and zero listed analyses. It does not report the analysis method for the primary endpoint, adjustment for baseline factors, how repeated or multiple events were treated, or whether any subgroup comparisons were planned. Details of multiplicity, missing-data handling, and statistical stopping procedures are not reported in the registry record. These absences limit interpretation of how the posted counts were selected and analyzed; they do not justify filling in a likely method from common practice.
The primary population is described as participants who were screened and received at least one dose of PF-06412528 from Week 1 to Week 4. This definition identifies an exposure-based safety population, but the record does not provide participant-level follow-up or explain how incomplete observation was handled. In general, interpretation of safety counts depends on knowing who contributed data, how much observation each person contributed, and how missing information was treated. Those details are not available in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 25 outcome measures, covering the primary adverse-event endpoint and secondary safety and pharmacokinetic outcomes. It lists zero analyses. A statistical plan specifying how outcomes were prioritized or tested is not reported in the registry record. The record does not say whether any multiplicity adjustment was used, whether formal hypothesis testing was planned, or whether some analyses were exploratory.
Multiplicity matters in general when many outcomes or comparisons are examined: the chance of observing an apparently notable result can increase as the number of statistical tests increases. Whether adjustment is appropriate depends on the questions and analysis plan. Because no analysis plan or outcome-specific test results are reported, no conclusion about multiplicity control can be drawn for this study. The sample-size planning illustration is described separately as based on an observed effect and assumed two-arm allocation; it is not evidence of the trial’s own prospective statistical plan.
The primary-outcome population includes participants who were screened and received at least one dose during Week 1 to Week 4. The record does not report how many participants had missing outcome information, how incomplete follow-up was treated, or whether all participants were observed for the full timeframe. It also does not explain whether missing data were excluded, imputed, or handled in another way. These details are not reported in the registry record.
Enrollment is recorded as 19, but that does not establish the denominator for every outcome or dose category. The adverse-event entries give their own at-risk counts, and those are the relevant denominators for interpreting the displayed group counts. The registry does not provide a complete participant flow or explain the relationship between the enrollment entry, the primary population, and each dose group.
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 |
|---|---|---|---|
| PF-06412528 <=20 mg | 2 | 6 | 33.3% |
| PF-06412528 >20-40 mg | 2 | 10 | 20.0% |
| PF-06412528 >40-80 mg | 2 | 3 | 66.7% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| PF-06412528 <=20 mg | 0 of 6 |
| PF-06412528 >20-40 mg | 0 of 10 |
| PF-06412528 >40-80 mg | 0 of 3 |
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 |
|---|---|
| PF-06412528 <=20 mg | 5 of 6 |
| PF-06412528 >20-40 mg | 9 of 10 |
| PF-06412528 >40-80 mg | 3 of 3 |
Most frequent serious adverse event terms
| Event term | Organ system | PF-06412528 <=20 mg | PF-06412528 >20-40 mg | PF-06412528 >40-80 mg |
|---|---|---|---|---|
| Sickle cell anaemia with crisis | Blood and lymphatic system disorders | 0 of 6 | 1 of 10 | 1 of 3 |
| Abdominal pain | Gastrointestinal disorders | 1 of 6 | 0 of 10 | 0 of 3 |
| Pyrexia | General disorders | 0 of 6 | 0 of 10 | 1 of 3 |
| Cholecystitis acute | Hepatobiliary disorders | 1 of 6 | 0 of 10 | 0 of 3 |
| Osteomyelitis | Infections and infestations | 0 of 6 | 1 of 10 | 0 of 3 |
| Pneumonia | Infections and infestations | 0 of 6 | 0 of 10 | 1 of 3 |
| Bone infarction | Musculoskeletal and connective tissue disorders | 0 of 6 | 0 of 10 | 1 of 3 |
| Acute respiratory distress syndrome | Respiratory, thoracic and mediastinal disorders | 0 of 6 | 0 of 10 | 1 of 3 |
Most frequent non-serious adverse event terms
| Event term | Organ system | PF-06412528 <=20 mg | PF-06412528 >20-40 mg | PF-06412528 >40-80 mg |
|---|---|---|---|---|
| Headache | Nervous system disorders | 3 of 6 | 4 of 10 | 1 of 3 |
| Nausea | Gastrointestinal disorders | 3 of 6 | 2 of 10 | 2 of 3 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 6 | 2 of 10 | 2 of 3 |
| Pain in extremity | Musculoskeletal and connective tissue disorders | 4 of 6 | 0 of 10 | 1 of 3 |
| Constipation | Gastrointestinal disorders | 2 of 6 | 2 of 10 | 0 of 3 |
| Pain | General disorders | 1 of 6 | 1 of 10 | 2 of 3 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 0 of 6 | 2 of 10 | 2 of 3 |
| Muscle spasms | Musculoskeletal and connective tissue disorders | 1 of 6 | 2 of 10 | 1 of 3 |
| Pruritus | Skin and subcutaneous tissue disorders | 1 of 6 | 2 of 10 | 1 of 3 |
| Vomiting | Gastrointestinal disorders | 2 of 6 | 0 of 10 | 1 of 3 |
Serious events with the highest arm-level rate: sickle cell anaemia with crisis (33.3%), pyrexia (33.3%), pneumonia (33.3%), bone infarction (33.3%), acute respiratory distress syndrome (33.3%).
The serious adverse-event entries are organized by dose group. In the <=20 mg group, 2 participants among 6 at risk had serious adverse events; in the >20-40 mg group, 2 among 10 did; and in the >40-80 mg group, 2 among 3 did. The other-adverse-event entries are 5 among 6, 9 among 10, and 3 among 3, respectively. These are counts within the registry’s stated groups, not results of a controlled comparison.
The serious-event term list includes five terms at 33.3% each and abdominal pain at 16.7%. The denominator and counting basis for those percentages are not stated in the record excerpt. They should not be assumed to represent the percentage of all participants or compared directly with the at-risk group counts. A term percentage may also not correspond to a unique participant count.
Zero deaths are recorded for each listed dose group. This is a description of the posted entries, not a conclusion about other serious outcomes. Since no control group, event-attribution analysis, or confidence intervals are reported, the counts alone do not establish comparative risk or causation.
12. What the Result Does, and Does Not, Mean
The registry record describes safety and pharmacokinetic evaluation of PF-06412528 in children ages 7–17 with moderate-to-severe pain. The primary result is a count of participants with treatment-emergent adverse events and serious adverse events during Week 1 to Week 4. The posted data report serious events and other adverse events within dose categories, along with a list of serious-event terms and zero deaths in each listed group.
These results show what was recorded in the reported groups and timeframe. They do not, by themselves, show whether the study drug caused an event. The endpoint definition includes events regardless of whether a causal relationship was considered possible. Nor do the counts establish how the observed event frequency compares with another treatment, placebo, or no treatment: the registry describes one open-label active arm and no comparator.
The record does not report a pain-relief result for the primary outcome, and no numerical result for the listed pharmacokinetic outcomes appears in the available information. Therefore, the safety counts cannot answer whether pain improved, how drug exposure varied, or whether one treatment is preferable to another. The study’s title and secondary outcome list describe those broader areas of interest, but the posted primary endpoint is specifically a safety count.
In general, estimates from small groups can be imprecise, and a count without an interval does not show the range of values that could be compatible with the data. The registry does not report confidence intervals or an inferential comparison for these results. A difference across dose groups should not be interpreted as a dose effect because allocation and comparability are not established in the record.
The status is terminated, but the reason is not reported in the registry record. Termination status alone does not explain the event counts or indicate whether the study ended because of safety, recruitment, logistics, or another reason. The data are best read as a descriptive safety record with limited information about comparison, event attribution, missing follow-up, and the broader treatment questions.
13. Why This Trial Matters Statistically
This trial is statistically notable because it concerns a pediatric population and reports safety outcomes as participant counts across dose ranges. A clear account of the population, timeframe, event definitions, and denominators is essential for reading such data. The registry defines treatment-emergent events and serious adverse events, and the posted entries identify the numbers at risk and affected within each listed dose group.
It also illustrates the distinction between describing events and estimating a treatment effect. Counts can document what occurred among treated participants, but a causal or comparative conclusion requires a design and analysis that support that question. The record describes an open-label active arm and does not report a control comparator or randomized allocation. Dose-group counts therefore serve as descriptive safety information, not as a direct comparison of dose strategies.
The endpoint’s definition adds an important interpretive point: an event qualifies regardless of whether a causal relationship is considered possible. This is useful for collecting safety information, while making it necessary to avoid treating every event as caused by the study drug. The serious-event categories also illustrate that seriousness is based on outcomes or significance criteria rather than simply event intensity.
Finally, the record makes visible the limits of registry interpretation. It lists 25 outcome measures but no analyses, and it does not report a statistical plan, multiplicity handling, confidence intervals, or missing-data methods. These omissions make it difficult to assess precision and analysis choices. Understanding those limits is part of responsible statistical interpretation, particularly when results are descriptive and groups are limited in size.
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 record identifies the study as open-label, with no masking and no reported comparator. It also notes that allocation is not stated and that the arms are not a like-for-like control comparison. Consequently, the posted adverse-event counts cannot establish comparative safety or isolate a treatment effect. The record does not describe whether participants in different dose groups were comparable in age, clinical status, or other characteristics.
The intervention labels are age-based, while the adverse-event results are presented by dose range. How these classifications relate is not reported in the registry record. No inference about age-specific event patterns or the way doses were selected can be made from the entries. The reason for study termination is also not reported, and status cannot be used to infer why the study ended.
The primary endpoint covers Week 1 to Week 4. The record does not explain the completeness of follow-up within this period or describe outcomes after it. Although the primary population definition refers to screened participants who received at least one dose, a participant flow or outcome-specific analysis population is not reported. Missing-data handling is not reported in the registry record.
For the serious-event terms, the denominator and counting basis for the listed percentages are not specified in the available record. It is therefore unclear whether percentages refer to participants, event reports, or another basis. The record also does not give detailed event-level attribution, duration, recurrence, or severity information. No confidence intervals or formal analysis results are listed, limiting assessment of precision and statistical uncertainty.
The study lists pharmacokinetic outcomes, including apparent volume of distribution and metabolite dose-exposure relationships, but numerical findings for those measures are not included in the information summarized in the record. The statistical plan, sample-size justification, and rationale for any planned analyses are not reported in the registry record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Safety and Pharmacokinetic Study of EMBEDA in Children Ages 7-17 With Pain — NCT02101554.
- Registry record last updated 2020-07-10; status last verified 2020-06.
- Results first posted 2020-07-10.
- 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
NCT02101554 is a Phase 4, open-label study of PF-06412528, identified in the title as EMBEDA, in children ages 7–17 with moderate-to-severe pain. The registry records enrollment of 19, status terminated, a start date of 2015-04-24, and a primary completion date of 2019-06-26. The reason for termination is not reported in the registry record.
The primary outcome counts participants with treatment-emergent adverse events and serious adverse events during Week 1 to Week 4. The record lists 25 outcome measures and zero analyses. Posted safety results are organized by dose range; the registry does not report a randomized control comparison, statistical analysis plan, confidence intervals, or missing-data methods. Secondary outcomes include safety measures and pharmacokinetic measures, but numerical results for those secondary measures are not included in the available record.