PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders (NCT00922428), a registered phase not stated study. The primary outcome is Visual Analog Scale (VAS).

2. Clinical Question

3. Trial Design

This record describes a non-interventional observational study of PASCOE-Agil HOM-Injektopas in people with rheumatic disorders. Its stated purpose is to provide an overview of use during a 2-4 week treatment period. The registry marks the study as completed and gives enrollment as 1389. The sponsor is Pascoe Pharmazeutische Praeparate GmbH. The record gives a start of 2009-01 and primary completion of 2009-05.

The described observational group covers patients with rheumatic disorders of different types and origins, especially arthralgia, myalgia, lumbago, or other diagnoses. The conditions listed in the record are broader than a single diagnosis. This makes the study a description of treatment use across a varied clinical population rather than a tightly defined comparison in one condition.

The primary measure is patient-completed VAS pain at the beginning, after 2 weeks, and after 4 weeks. The registry says the outcome population is all patients who had a value, described as appropriate to the observational character of the study. It does not give the number with values at each visit or explain how missing measurements were handled.

No randomized comparison is described, and allocation is not stated. There is no separate comparator arm in the record; therefore, the visit-to-visit assessments are observations within the treated group, not a randomized contrast. The record lists Acceptance of the Drug as a secondary outcome. It lists 10 outcome measures and 0 analyses, but does not provide a statistical analysis plan or numerical results for the primary VAS outcome. Further protocol details, including treatment specifics and recruitment procedures, 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: The observational study was carried out between January 2008 and the end of May 2008 by 280 therapists. The non-interventional character of an observational study meant that no exact timeframe for the treatment of patients was specified.

Overall Study

Reasons for not completing this period:

Analysis population for the primary outcome, as defined in the registry: due to character of an observational study: all patient who had a value, descriptive

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.

6. Primary Endpoint

The registry lists the primary outcome as Visual Analog Scale (VAS), measured over Beginning (Visit 1) and after 2 (visit 2) + 4 weeks (Visit3).

The primary endpoint is the Visual Analog Scale (VAS), a patient-reported measure of pain. The registry defines its scale from 0, best or no pain, to 10, worst or intolerable pain. It describes the outcome as a mean with standard deviation and schedules assessment at the beginning (Visit 1), after 2 weeks (Visit 2), and after 4 weeks (Visit 3).

A patient-reported pain measure captures the patient’s own experience rather than relying only on an observer’s judgment. In general, a VAS turns that experience into a numeric measure that can be summarized across participants and compared across assessment times. A mean describes the center of the observed scores; a standard deviation describes how spread out individual scores are around that mean. Neither summary alone describes every participant’s experience.

The registry’s outcome description says that the VAS was filled by the patient and that the analysis population was all patients with a value. It does not report the mean or standard deviation at any visit, the number of available values at each visit, or a change estimate. Consequently, the endpoint definition is available, but the size and precision of any observed pain change cannot be assessed from the registry record.

7. Why No Re-analysis Is Shown

8. Statistical Interpretation

9. Statistical Methods Explained

The registry identifies a continuous primary outcome summarized as a mean with standard deviation. For a continuous measure such as VAS pain, a mean gives a concise description of the average recorded score in a group. The standard deviation describes the degree of variation among scores. These summaries answer different questions: the mean locates the group average, while the standard deviation conveys how heterogeneous the observations are. Neither reveals the full distribution or replaces individual-level information.

What would a change in mean describe?

In general, comparing mean VAS scores across visits can describe how the average score differs over time among participants with recorded measurements. A within-group change is not the same as a treatment-versus-control effect. Without a comparator, other influences on symptoms and measurement can occur alongside treatment. The registry does not report the visit means or a change estimate, so no numerical change can be interpreted.

What does a confidence interval add?

In general, a confidence interval communicates the statistical uncertainty around an estimate under the assumptions of the analysis. A narrow interval indicates greater precision than a wide interval, while an interval spanning values compatible with different conclusions may leave substantial uncertainty. It does not repair limitations in study design, missing data, or measurement. No confidence interval for the VAS outcome is reported in the registry record, so the precision of an effect estimate is unavailable.

Why does the analysis population matter?

The registry describes the primary outcome population as all patients who had a value, consistent with the observational character of the study. A measurement-based population can vary from visit to visit if some participants do not provide scores. General statistical practice distinguishes the people eligible for an analysis from those actually contributing data, because the reason for missingness can affect interpretation. The record does not state how many had a VAS value at each visit, whether the same participants contributed at every visit, or how missing values were addressed.

What can observational follow-up establish?

Repeated observation can describe changes among recorded scores over time. It does not, by itself, establish that treatment caused those changes. In a non-randomized study, treatment use and outcomes may be associated with characteristics or events that are not controlled by assignment. A comparator can help distinguish changes associated with treatment from changes that would also occur without it, but no separate comparator is described in this record. Allocation is not stated, so there is no basis for interpreting the design as randomized.

What do the planning assumptions mean?

The registry includes assumptions for planning illustrations based on an observed effect: a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The illustrations are explicitly separate from the study’s own design, and the study itself is observational with no described two-arm comparison. The assumed effect to detect is a stated fraction of the observed effect. Such illustrations can show how hypothetical design choices relate to a sample-size requirement; they do not indicate the study’s actual enrollment target, demonstrate that the study had adequate power, or constitute observed power. No particular planning result is needed to interpret the registry’s reported outcome, which lacks numerical VAS estimates.

How should over-dispersion be understood?

In general, over-dispersion means that observed variability exceeds what a model assumes. If a model understates variability, its uncertainty estimates may be too small and statistical evidence may appear stronger than warranted. This is a general consideration in statistical modeling, not a feature established for this trial: the registry does not report an analysis model, model diagnostics, or a dispersion assessment. The primary outcome is described using a mean and standard deviation, and no inferential analysis is listed.

What is absent from the analysis description?

The registry lists 10 outcome measures and 0 analyses. It does not report a statistical analysis plan, an adjustment strategy, a model for repeated measurements, a method for handling missing observations, or a precision estimate. The record also does not state whether any interim analyses occurred. Those methods cannot be reconstructed from the outcome definition or from sample-size planning assumptions. The most defensible interpretation is therefore descriptive: the registry specifies an intended repeated patient-reported pain measure, but does not provide the estimates needed to assess change or its uncertainty.

10. Confidence Intervals for Each Arm

No two-arm comparison is shown for this trial, but each arm's mean can be given with a t-based 95% confidence interval computed from the posted mean, spread and number of participants.

R code and output

arm <- c("Observational (Visit 1)", "Observational Group (Visit 2)", "Observational Group (Visit 3)")
n   <- c(1368, 1341, 1214)
m   <- c(6.57, 4.23, 2.61)
sp  <- c(1.75, 2.03, 2.03)
sd  <- sp      # posted standard deviations
for (i in seq_along(n)) {
  se <- sd[i] / sqrt(n[i]); h <- qt(0.975, n[i] - 1) * se
  cat(sprintf("CARM|%s|%d|%.3f|%.3f|%.3f|%.3f\n", arm[i], n[i], m[i], sd[i], m[i] - h, m[i] + h))
}

CARM  Observational (Visit 1)  1368  6.570  1.750  6.477  6.663
CARM  Observational Group (Visit 2)  1341  4.230  2.030  4.121  4.339
CARM  Observational Group (Visit 3)  1214  2.610  2.030  2.496  2.724

11. Multiplicity, Missing Data and Analysis Populations

The registry lists 10 outcome measures, including the primary VAS outcome and the secondary outcome Acceptance of the Drug. It lists 0 analyses. The record does not describe which outcomes were tested, whether any hypothesis tests were planned, or how multiplicity was addressed. When multiple outcomes or comparisons are examined, general statistical practice considers the possibility of false-positive findings from repeated testing. Whether that issue arose in this study cannot be determined from the registry record because test results and an analysis plan are not reported.

Missing data are also insufficiently described. The primary outcome population is characterized as all patients who had a value, but visit-specific counts and reasons for missing scores are not reported in the registry record. The record does not say whether a participant needed values at every visit to contribute to a change analysis, or whether any imputation or other missing-data method was used. If availability of a score is related to symptoms or treatment experience, summaries among those with measurements may not represent everyone enrolled. The registry does not allow that risk to be quantified or resolved.

The record does not provide a detailed analysis population beyond its description of patients with a VAS value. It does not specify a protocol-defined population, a modified population, or an approach to deviations from treatment. Nor does it report interim analyses or a prespecified statistical plan. These are omissions in the registry record, not evidence that particular procedures were or were not used outside it.

12. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 1% reporting threshold.

Most frequent non-serious adverse event terms

The adverse-event record gives 1376 as at risk for both serious and other adverse events. It records 0 serious adverse events and 23 other adverse events in the observational group. These entries should be read as the posted counts, not as estimates of comparative risk: there is no control group described against which to compare them. The serious-event terminology list is empty, and deaths are not reported in the registry record.

The figures do not describe event types beyond the category totals, nor do they give information about timing, duration, severity within the non-serious category, attribution to treatment, or participant-level overlap. The record also does not explain how safety events were collected or whether reporting was complete. Accordingly, the reported 0 is not a basis for concluding that serious events could not occur, and the count of 23 does not by itself establish that treatment caused those events. These are descriptive registry entries whose context and completeness are not reported.

13. What the Result Does, and Does Not, Mean

The study record is useful for understanding what was observed: clinical use of PASCOE-Agil HOM-Injektopas in patients with varied rheumatic disorders, with patient-reported pain intended to be assessed at the beginning and after 2 and 4 weeks. It also records Acceptance of the Drug as a secondary outcome and gives adverse-event counts. This gives a basic outline of the study question and the types of information the registry was designed to capture.

It does not establish whether pain improved, worsened, or remained unchanged. The registry does not provide VAS means, standard deviations, changes, or confidence intervals. Without those results, the magnitude and precision of the primary outcome cannot be described. The registry’s statement that the analysis population included patients with a value does not reveal how many measurements were available at each visit or whether missingness could affect the summaries.

Even complete within-group VAS results would describe change over time rather than isolate a causal treatment effect in this design. The study is non-interventional, with one observational group and no separate comparator described. The record therefore cannot distinguish a treatment-associated change from other influences on pain over follow-up. Allocation is not stated, and the record gives no basis for treating the study as randomized.

The reported safety entries should likewise be interpreted descriptively. The record lists 0 serious adverse events and 23 other adverse events among 1376 at risk, but does not provide details needed to assess attribution or reporting completeness. The study is not a comparative safety assessment in the registry description.

Overall, the registry defines an observational study and its intended measurements, but does not provide the outcome estimates needed to judge the observed pattern or its precision. It cannot, on its own, support a conclusion that the treatment does or does not work. Such a conclusion would require numerical results and a design capable of addressing alternative explanations for observed change.

14. Why This Trial Matters Statistically

This study illustrates an important distinction in clinical statistics: defining an outcome is not the same as reporting its results. The registry gives a clear description of a patient-reported pain measure, its direction, and its scheduled visits. It also identifies a mean and standard deviation as the summary form. Yet the absence of numerical VAS results means readers cannot assess the observed level of pain, change over time, or precision. An endpoint description is necessary for interpretation but cannot replace an estimate.

The observational design also highlights the difference between describing a trajectory and estimating a causal effect. Repeated measurements can show how recorded scores vary across visits, but without a comparator they cannot establish what would have happened in the absence of treatment. That distinction matters whenever before-and-after findings are discussed: time trends are not automatically treatment effects.

The record further shows why denominators and analysis populations need context. It identifies 1376 at risk for the safety categories and describes the primary outcome population as patients with a value, but does not explain visit-level availability or missingness. Counts are meaningful only in relation to how events and measurements were captured. Here, the missing details limit conclusions about completeness and representativeness.

Finally, planning illustrations based on an observed effect are not evidence that the observational study was designed as a randomized comparison or that it had a particular power. The listed planning assumptions describe hypothetical design calculations; they do not replace an analysis plan or outcome results. Keeping these distinctions visible helps prevent descriptive registry information from being interpreted as stronger evidence than it can support.

15. 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 primary limitation is the absence of numerical results for the primary VAS endpoint. Although the registry specifies means and standard deviations at the beginning and after 2 and 4 weeks, it does not report those values or a change estimate. Statistical precision cannot be judged without uncertainty estimates such as confidence intervals. The outcome description alone cannot establish the direction or size of a change.

The observational design has no separate comparator described. A change in pain during follow-up could have explanations other than treatment, and the registry does not provide a design feature that separates those explanations. The record is also broad in its description of rheumatic disorders, including different types and origins and several diagnosis examples. It does not report outcome results by diagnosis or other patient characteristics.

The record describes an outcome population consisting of patients who had a value, but does not state visit-specific measurement availability, reasons for missing scores, or handling of missing data. It also does not report details of treatment dose, schedule, adherence, concomitant care, or event ascertainment. These details are not reported in the registry record and should not be inferred.

Safety interpretation is limited by the lack of event descriptions and context. The record reports counts but does not provide attribution, timing, or completeness information; deaths are not reported in the registry record. The record also lists 10 outcome measures and 0 analyses without supplying a statistical analysis plan or multiplicity approach. Together, these gaps restrict both efficacy and safety interpretation to a description of the registry entries rather than a firm estimate of treatment effects.

16. Related Tutorials

17. Related Statistical Calculators

18. Sources

• ClinicalTrials.gov: PASCOE-Agil HOM-Injektopas in the Treatment of Rheumatic Disorders — NCT00922428.
• Registry record last updated 2015-05-04; status last verified 2015-04.
• Results first posted 2015-05-04.
• 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.

19. Record Summary

NCT00922428 is a completed, non-interventional observational study sponsored by Pascoe Pharmazeutische Praeparate GmbH. Registry enrollment is 1389. The study describes use of PASCOE-Agil HOM-Injektopas in rheumatic disorders over a 2-4 week treatment period, with patient-reported VAS pain as the primary outcome. The scale ranges from 0, best or no pain, to 10, worst or intolerable pain, and assessments are specified at the beginning and after 2 and 4 weeks.

No separate comparator is described, and allocation is not stated. Numerical VAS results and an analysis plan are not reported in the registry record. The safety entries list 0 serious adverse events and 23 other adverse events among 1376 at risk; deaths are not reported. The available record therefore defines the observational question and selected measures, but does not provide enough outcome information to estimate change or its precision.