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 Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease (NCT01404936), a na phase 2 study. The primary outcome is Participants' Response.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01404936 |
| Phase | Phase 2 |
| Condition | Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 35 |
| Arms in the primary outcome | n/a |
| Lead sponsor | M.D. Anderson Cancer Center |
| Results posted | Yes |
2. Clinical Question
Population
Patients with Hodgkin's disease. The registry lists the condition as lymphoma and reports enrollment of 35 participants. It does not report further eligibility details in the registry record.
Intervention
Interferon-2A given with Adriamycin, Bleomycin, Velban, and Dacarbazine, the combination referred to as ABVD. The registry describes the study as examining the addition of interferon to chemotherapy.
Comparator
There is no separate control group in this single-group study. The record does not describe a randomized or like-for-like comparison with ABVD alone.
Primary question
The registry states that the study would assess whether adding interferon to ABVD improves the immune response against Hodgkin's disease and whether toxicity increases. The listed primary outcome is participants' response after 6 courses (3 months), classified using tumor-response definitions. The registry does not report a comparative estimate answering either question.
3. Trial Design
This is a phase II, single-group study of interferon-2A with ABVD chemotherapy. The registry lists 35 participants as enrolled and the study status as completed. The recorded start is 1996-07, and primary completion is recorded as 2011-12. Allocation is listed as NA, masking as none, and the model as single group. These features mean the record does not describe a randomized, blinded comparison between treatment groups.
The intervention description combines interferon-2A with Adriamycin, Bleomycin, Velban, and Dacarbazine. The registry's arm description specifies interferon administration on Days 1 - 4 and ABVD on Day 4. This identifies the regimen recorded for the study, but details beyond that description, including the rationale for particular dose or schedule choices, are not reported in the registry record.
The study's stated aims concern immune response and toxicity when interferon is added to ABVD. However, the primary outcome listed is participants' response after 6 courses (3 months), with tumor response categorized as complete response, partial response, no change, or progressive disease. Those categories describe clinical status; they are not a direct measure of immune response. The registry record does not explain how the listed primary outcome relates to the immune-response aim.
The registry does not report a sample-size justification or a detailed statistical analysis plan. It lists no analyses. Without a control group, the study's design can describe outcomes in the treated group, but it cannot by itself separate treatment-associated changes from other explanations or estimate a comparative treatment effect.
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: Of the 35 participants registered, five (5) were excluded from the trial.
Overall Study
| Stage | Interferon-2A + Chemotherapy |
|---|---|
| STARTED | 30 |
| COMPLETED | 30 |
| NOT COMPLETED | 0 |
Analysis population for the primary outcome, as defined in the registry: Two patients did not complete therapy; however, they were included in the intent-to-treat analysis. One patient was censored at the last follow-up date since no events had occurred.
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 | Interferon-2A + Chemotherapy |
|---|---|---|
| Participants analysed | 30 | |
| Age Continuous | years | 30 (18 to 62) |
| Sex: Female, Male: Female | Participants | 10 |
| Sex: Female, Male: Male | Participants | 20 |
| Region of Enrollment: United States | participants | 30 |
6. Primary Endpoint
The registry lists the primary outcome as Participants' Response, measured over After 6 courses (3 months).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is listed as participants' response after 6 courses (3 months). It classifies tumor status using four categories. Complete response means disappearance of all clinical evidence of active tumors for a minimum of 8 weeks. Partial response means a 50% or greater decrease in the sum of products of all measured lesions that persists for at least 4 weeks. No change means a steady state or change of +/- 25% of tumor size, without progression for a minimum of 8 weeks and with no new lesions. Progressive disease is defined as an increase of > 25 % in the size of any measurable lesion or the appearance of significant new lesions.
In general, a response endpoint is used to describe whether disease measurements meet prespecified categories over a defined assessment period. Requiring a change to persist can distinguish a sustained classification from a brief measurement fluctuation. The registry supplies category definitions and a timeframe, but does not report the number of participants in each category or an overall response estimate. It also does not state in the registry record how response categories were combined for any summary analysis.
The outcome is a participant count, rather than a continuous measurement. The registry says two patients did not complete therapy but were included in the intent-to-treat analysis; it also says one patient was censored at the last follow-up date because no events had occurred. Further details about the endpoint's handling of those observations are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available record describes a phase II study in which 35 participants were enrolled in a single group receiving interferon-2A with ABVD. It identifies participants' response after 6 courses (3 months) as the primary outcome and provides definitions for response categories. It does not report the response counts, an estimated response proportion, a confidence interval, or a statistical test for that endpoint. Consequently, the posted outcome information does not quantify how participants' responses were distributed or how precisely any response rate was estimated.
The study's stated research aim includes whether adding interferon improves the immune response and increases toxicity. But an interpretable treatment contrast requires a comparator group or another suitable source of comparison. The registry records a single-group model and no randomized comparison. Outcomes in this group therefore cannot establish what would have happened to comparable participants receiving ABVD without interferon. The registry does not report a comparative estimate for immune response, tumor response, or toxicity.
The record does include safety counts for the intervention group: 3 serious adverse events among 30 participants at risk, and 30 participants affected by other adverse events among 30 at risk. The listed serious terms are Cytopenia, Hepatotoxicity, and Pulmonary Toxicity, each reported as 3.3%. These figures describe the registry's reported counts and terms; they do not establish that an event was caused by the treatment. The record does not report deaths.
In general, an estimate should be read together with its uncertainty. A confidence interval describes a range of values compatible with the data under the analysis assumptions; without an estimate and interval, the precision of the primary result cannot be assessed. The registry also lists no analyses, so there is no posted model output or hypothesis test to interpret.
The result record is therefore informative about the study design, its response definitions, and selected safety counts, but not about the magnitude or precision of the primary response outcome. The sample-size planning illustrations use assumptions stated separately from the trial's own design; they are not observed outcomes, and they should not be mistaken for evidence of treatment effect or for the study's actual sample-size justification.
9. Statistical Methods Explained
The registry identifies the study as phase II, single group, with allocation listed as NA and masking listed as none. These descriptions matter because they determine what kinds of statistical conclusions the design can support. A single-group study can describe outcomes among participants receiving the recorded regimen. In general, it does not provide the concurrent untreated or alternative-treatment observations needed to estimate a between-group contrast. The registry record does not report a randomized comparison.
What does a single-group design estimate?
In general, a single-group analysis can estimate a response proportion or describe event counts within the treated group, if the outcome data and analysis are reported. That quantity is a description of the observed group. It is not automatically an estimate of the difference between treatment strategies. Without a comparator, an observed response could reflect treatment, the course of disease, participant selection, measurement, or other factors. The record does not provide data that separate these explanations.
The primary endpoint is a categorical participant response after 6 courses (3 months). For a binary outcome, a common statistical summary is the number with the event relative to the number assessed, accompanied by an uncertainty interval. Here, the registry lists the outcome as a participant count and provides response definitions, but the outcome results and an analysis are not reported in the registry record. No response estimate or interval can therefore be interpreted from the registry entry.
What would an uncertainty interval mean?
In general, a confidence interval expresses uncertainty around an estimate under the assumptions of a statistical method. It is not a guarantee that the true value falls within the interval, and it does not address bias created by design limitations or missing data. A narrow interval can indicate greater statistical precision than a wide interval, but precision is distinct from whether the estimate is causally interpretable. The registry does not report a confidence interval for the primary outcome.
What can a significance test show?
In general, a significance test evaluates how compatible observed data are with a specified null hypothesis and model. A p-value does not measure the size or clinical importance of an effect, nor does it repair the lack of a comparator. No p-value or primary-outcome analysis is reported in the registry record. The record also does not report which hypothesis, if any, was tested for the response endpoint.
How should the planning illustrations be read?
The planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The stated effect to detect is a fraction of the observed effect. For time-to-event outcomes, the stated convention is a total number of events; for other outcomes, it is participants per arm. These assumptions describe a planning exercise, not the design recorded for this single-group trial. The registry does not report the trial's own sample-size justification, and the illustrations must not be interpreted as observed power.
In general, a sample-size calculation is conditional on choices about the target effect, variability or event frequency, error rates, allocation, and analysis method. Changing these assumptions changes the planning result. A calculation based on an observed effect is especially a retrospective planning illustration: the observed effect is not itself a guarantee of replication. The registry does not report the specific protocol rationale or calculation used to enroll participants.
Why does over-dispersion matter?
In general, over-dispersion occurs when observed variation is greater than a statistical model assumes. If a model ignores this extra variation, its uncertainty estimates can be too small and its tests can be too optimistic. This concept is relevant to outcomes such as counts when the chosen count model assumes less variability than the data have. The registry record does not report a count model or an over-dispersion assessment for this trial, so no conclusion about its presence or handling can be made.
More broadly, the registry does not report the statistical methods used to analyze the primary outcome, any model specification, or any adjustment strategy. The listed endpoint definitions and the reported design alone do not reveal those methods. Any interpretation should therefore distinguish the documented study structure and counts from analyses that are not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists one outcome measure and no analyses. It does not report a multiplicity plan, a hierarchy of endpoints, or adjustments for testing multiple outcomes or subgroups. Multiplicity arises in general when several hypotheses are tested; repeated testing can increase the chance of finding a nominally unusual result by chance. Whether that issue applied to the study's analyses cannot be determined because the analysis plan is not reported in the registry record.
The primary response is described using several outcome categories, but the registry does not report the count in each category or how the categories were summarized for analysis. It also does not report whether any additional response, immune-response, or toxicity analyses were conducted. The study aims mention immune response and toxicity, while the listed primary measure is participants' response. The record does not explain any endpoint hierarchy or how these aims were handled statistically.
For missing data and analysis populations, the record states that two patients did not complete therapy and were included in the intent-to-treat analysis. It also states that one patient was censored at the last follow-up date because no events had occurred. These statements do not provide a full accounting of missing primary-outcome observations, the response classification for participants who did not complete therapy, or the method used to address missing measurements. Further details are not reported in the registry record.
In general, intent-to-treat analysis refers to analyzing participants according to their assigned group, but this study is recorded as single group and the registry does not describe the exact analysis rules. Censoring is generally used when an event time is not observed during follow-up; how it affects an estimate depends on the endpoint and method. The registry's note about one censored patient does not identify an event-time analysis or provide its results. The record does not report sensitivity analyses for missing data or a detailed analysis-population definition.
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 |
|---|---|---|---|
| Interferon-2A + Chemotherapy | 3 | 30 | 10.0% |
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 |
|---|---|
| Interferon-2A + Chemotherapy | 30 of 30 |
Most frequent serious adverse event terms
| Event term | Organ system | Interferon-2A + Chemotherapy |
|---|---|---|
| Cytopenia | Blood and lymphatic system disorders | 1 of 30 |
| Hepatotoxicity | Hepatobiliary disorders | 1 of 30 |
| Pulmonary Toxicity | Respiratory, thoracic and mediastinal disorders | 1 of 30 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Interferon-2A + Chemotherapy |
|---|---|---|
| Nausea | Gastrointestinal disorders | 20 of 30 |
| Fever | Investigations | 10 of 30 |
| Asthenia | General disorders | 2 of 30 |
| Psychiatric Disorders | Psychiatric disorders | 2 of 30 |
Serious events with the highest arm-level rate: cytopenia (3.3%), hepatotoxicity (3.3%), pulmonary toxicity (3.3%).
The registry reports safety information for the Interferon-2A + Chemotherapy group. For serious adverse events, 30 participants are listed as at risk and 3 as affected. For other adverse events, 30 are listed as at risk and 30 as affected. The registry lists Cytopenia, Hepatotoxicity, and Pulmonary Toxicity among the top serious terms, each at 3.3%. These counts and percentages are descriptions of what the registry reports, not a comparison with another treatment group.
In general, an adverse event is an event observed during a study; its appearance in a safety record does not by itself establish that the intervention caused it. A causal assessment would require information beyond a count, including context and a comparison strategy. No separate control group is recorded, and the registry does not report an attribution analysis. The listed serious terms also do not provide full detail about severity, timing, duration, or whether the same participant had more than one term.
The deaths field is not reported in the registry record. The record does not give further definitions or analysis details for the other-adverse-event count. The figures should therefore be read as reported safety counts with limited context, rather than as a complete account of risk or as evidence for a treatment comparison.
12. What the Result Does, and Does Not, Mean
The registry supports a limited description of the trial: it was a completed phase II, single-group study of interferon-2A with ABVD, with 35 participants enrolled. Its primary outcome was participants' response after 6 courses (3 months), defined by categories of tumor change and persistence. The registry also records safety counts for the intervention group. These registry entries identify what the study set out to examine and what aspects of the results are present in the record.
The record does not report the primary response counts, a response estimate, uncertainty interval, or statistical test. It therefore does not show how many participants met each response category or how precisely a group response rate could be estimated. Although the study description refers to immune response, the listed primary endpoint is tumor response, and the registry does not report a measured immune-response result.
The single-group design also limits causal interpretation. Without a concurrent comparison group, outcomes among participants receiving interferon with ABVD cannot establish the difference relative to ABVD alone. The registry does not report a comparative effect estimate. The safety counts can describe events recorded in the treated group, but cannot by themselves determine whether the regimen caused them or how its safety compares with another regimen.
In general, statistical precision and causal strength are different issues. A precise estimate may still be subject to design limitations, while a design with a comparator may still yield imprecise results. In this record, the absence of posted primary-outcome analysis prevents assessment of precision, and the single-group design prevents a direct treatment contrast. No conclusion about treatment benefit or lack of benefit follows from the available registry information alone.
13. Why This Trial Matters Statistically
This study illustrates why the design and the reported analysis need to be considered together. The registry states a question about adding interferon to ABVD, but records the study as single group with allocation listed as NA. That design can describe the experience of participants receiving the regimen, but does not provide a like-for-like control comparison. The distinction is essential when a research question is phrased comparatively.
It also illustrates the difference between a stated aim and the endpoint actually listed. The brief summary refers to immune response and toxicity; the primary outcome is participants' response after 6 courses (3 months), classified by changes in tumor measurements. A reader needs to know whether the endpoint directly measures the target of the research question. The registry does not explain the relationship between these measures or report an immune-response analysis.
Finally, the record shows why outcome definitions alone are not enough to interpret results. Detailed definitions make clear what complete response, partial response, no change, and progressive disease mean operationally. But without reported category counts, an effect estimate, or uncertainty, the definitions cannot convey the observed outcome or its precision. The reported adverse-event counts likewise need context about attribution, timing, and comparison.
These distinctions are useful across clinical research: design determines the comparisons available, endpoint choice determines what is measured, and reporting determines what can be evaluated. Here, the registry documents important design and endpoint details, while leaving the primary outcome analysis and several methods questions unreported.
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 main trial-specific limitation for interpretation is the single-group design. The registry does not describe a control arm, randomization, or a direct comparison with ABVD alone. As a result, the study record cannot provide a randomized estimate of the added effect of interferon. Its listed design supports description of the intervention group, not a like-for-like treatment contrast.
The primary endpoint is described, but its results are not reported in the registry record. The number of participants in each response category, the analysis denominator, and any estimate or uncertainty interval are not available in the posted outcome information. The registry lists no analyses, so the method used to summarize the response outcome cannot be assessed.
The registry notes that two patients did not complete therapy but were included in the intent-to-treat analysis, and that one patient was censored at the last follow-up date because no events had occurred. It does not provide enough detail to determine how those observations were handled in the primary response analysis or whether other outcome data were missing. A full missing-data strategy is not reported in the registry record.
The study's stated aims include immune response and toxicity, but the listed primary outcome is tumor response. The registry does not report an immune-response result or explain the connection between the aim and endpoint. Safety information is also limited: event counts and selected serious terms are listed, but deaths are not reported in the registry record, and attribution, timing, and severity details are not given. The registry does not report a sample-size justification or detailed statistical plan.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of a-Interferon With Adriamycin, Bleomycin, Velban, and Dacarbazine (ABVD) With Hodgkin's Disease — NCT01404936.
- Registry record last updated 2013-02-01; status last verified 2013-01.
- Results first posted 2013-02-01.
- 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.
Continue through the Clinical Biostats statistical pathway
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
The registry describes a completed phase II, single-group study of interferon-2A with ABVD for patients with Hodgkin's disease. It lists 35 participants enrolled, a study start of 1996-07, and primary completion in 2011-12. The primary outcome is participants' response after 6 courses (3 months), classified by tumor-response criteria.
The record states that two patients did not complete therapy but were included in the intent-to-treat analysis, and that one patient was censored at the last follow-up date because no events had occurred. It reports serious adverse events in 3 of 30 participants at risk and other adverse events in 30 of 30 at risk; three serious terms are each listed at 3.3%.
Primary response results, analyses, and a comparative estimate are not reported in the registry record. The single-group design does not provide a like-for-like control comparison.