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 Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma (NCT01780662), a na phase 1, phase 2 study. The primary outcome is Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01780662 |
| Phase | Phase 1, Phase 2 |
| Condition | Recurrent Adult Hodgkin Lymphoma, Recurrent Childhood Hodgkin Lymphoma, Refractory Childhood Hodgkin Lymphoma |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 46 |
| Arms in the primary outcome | n/a |
| Lead sponsor | National Cancer Institute (NCI) |
| Results posted | Yes |
2. Clinical Question
Population
The study concerned pediatric and young adult patients with Hodgkin lymphoma that had returned or was refractory to treatment. The registry condition list also includes recurrent adult Hodgkin lymphoma. The primary endpoint description specifies eligible patients; it identifies the primary endpoint population as N=45 and notes that one patient was ineligible because the interval between disease evaluation and study entry exceeded the prescribed interval.
Intervention
Patients received brentuximab vedotin together with gemcitabine hydrochloride. The registry describes brentuximab vedotin as an intravenous infusion on day 1 and gemcitabine hydrochloride as an intravenous infusion on days 1 and 8, with treatment repeating every 21 days. The planned treatment description allows up to 15 more courses, subject to disease progression or unacceptable toxicity.
Comparator
There was no randomized control group. The registry identifies the design as single group, with allocation listed as not applicable and no masking. The reported dose groups should not be read as randomized treatment and control arms or as a like-for-like comparison.
Primary question
The primary endpoint was the number of eligible patients who experienced a grade 3 or higher adverse event, graded using NCI CTCAE Version 4.0, during Phase 1 and Phase 2. Its timeframe was 13 months from first dose. The registry record does not report the primary endpoint result, so the event count for this endpoint cannot be described from the available record.
3. Trial Design
NCT01780662 is a completed phase 1/2 study sponsored by the National Cancer Institute. Its stated purpose was to study side effects and dose, as well as assess the combination of brentuximab vedotin and gemcitabine hydrochloride in younger patients with relapsed or refractory Hodgkin lymphoma. The registry reports enrollment of 46. The primary endpoint description identifies 45 eligible patients and explains that one patient was ineligible because the interval between disease evaluation and study entry exceeded the prescribed interval.
The design is listed as single group, with allocation not applicable and masking none. The record includes two dose groups, labeled Dose1.4mg/kg and Dose 1.8mg/kg. These are not randomized comparison arms: the registry does not describe random assignment, and its own design fields identify a single-group study. Differences between the dose-group counts therefore cannot be interpreted as randomized treatment effects. The record does not report the process used to assign patients to dose groups.
The regimen description specifies brentuximab vedotin intravenously over 30 minutes on day 1 and gemcitabine hydrochloride intravenously over 100 minutes on days 1 and 8. Courses repeat every 21 days, for up to 15 more courses, unless disease progression or unacceptable toxicity occurs. The treatment description also begins to describe a possible stopping condition after complete response, but the registry entry is truncated at that point; the full condition is not reported in the registry record.
The registry lists nine outcome measures and no statistical analysis records. It describes secondary measures that include disease response, successful peripheral blood stem cell collection, plasma TARC, a relationship between miRNA and response, and an FcyRIIIa-158 polymorphism. The registry record does not provide results for those measures in the registry record. Trial start and primary completion dates are recorded as 2013-01-31 and 2017-09-30, and the study status is completed.
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 Phase I /II study. Phase I determined the Maximum Tolerated Dose (MTD) between the first 2 treatment arms; 16 patients enrolled and 9 patients completed therapy. The study was closed and reopened to accrual for Phase II which enrolled an additional 30 patients. Overall, 46 patients were enrolled but only 29 patients completed therapy.
Overall Study
| Stage | Phase I, 1.4mg/kg | Phase I, 1.8mg/kg | Phase II, 1.8mg/kg |
|---|---|---|---|
| STARTED | 3 | 13 | 30 |
| COMPLETED | 2 | 7 | 20 |
| NOT COMPLETED | 1 | 6 | 10 |
Reasons for not completing this period:
| Reason | Phase I, 1.4mg/kg | Phase I, 1.8mg/kg | Phase II, 1.8mg/kg |
|---|---|---|---|
| Adverse Event | 1 | 0 | 2 |
| Physician Decision | 0 | 5 | 7 |
| Protocol Violation | 0 | 1 | 0 |
| Ineligible | 0 | 0 | 1 |
Analysis population for the primary outcome, as defined in the registry: The first 9 out of 16 patients enrolled with relapsed/refractory HL in a phase 1 dose finding study of brentuximab vedotin in combination with gemcitabine, were used in determining MTD
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 | Phase I Dose 1.4 mg/kg | Phase I Dose 1.8 mg/kg | Phase 2 Dose 1.8 mg/kg | Total |
|---|---|---|---|---|---|
| Participants analysed | 3 | 13 | 30 | 46 | |
| Age, Categorical: <=18 years | Participants | 3 | 10 | 24 | 37 |
| Age, Categorical: Between 18 and 65 years | Participants | 0 | 3 | 6 | 9 |
| Age, Categorical: >=65 years | Participants | 0 | 0 | 0 | 0 |
| Sex: Female, Male: Female | Participants | 1 | 8 | 16 | 25 |
| Sex: Female, Male: Male | Participants | 2 | 5 | 14 | 21 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 2 | 9 | 11 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 3 | 11 | 20 | 34 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 1 | 1 |
| 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 | 0 | 2 | 6 | 8 |
| Race (NIH/OMB): White | Participants | 3 | 10 | 19 | 32 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 5 | 6 |
| Region of Enrollment: United States | Participants | 3 | 13 | 28 | 44 |
| Region of Enrollment: Canada | Participants | 0 | 0 | 2 | 2 |
6. Primary Endpoint
The registry lists the primary outcome as Adverse Events Graded According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0, measured over 13 months from first dose.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint counts eligible patients who experienced one or more grade 3 or higher adverse events, graded according to NCI CTCAE Version 4.0. The stated observation window is 13 months from first dose, and the endpoint description covers Phase 1 and Phase 2. This is a participant count, not an event count: the stated measure concerns how many patients had qualifying adverse events, rather than how many separate episodes occurred.
Adverse-event grading gives a structured way to classify the severity of events. In general, a higher grade denotes greater severity under the grading system; the endpoint uses the threshold of grade 3 or higher. Such a safety measure is relevant in a phase 1/2 study that is concerned with dose and side effects, because it describes the number of eligible participants who met a defined severity threshold during the stated follow-up window. It does not, on its own, explain the cause of an event or establish whether the study treatment caused it.
The registry record identifies the primary population as N=45 and notes that one patient was ineligible. It does not report the observed count for this primary endpoint. The serious and other adverse-event counts listed by dose group are separate registry safety figures; they cannot substitute for the grade 3 or higher primary endpoint result because the record does not state that those measures use the same event definition, severity threshold, or observation window.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The design and outcome information support a descriptive reading, not a comparative treatment-effect conclusion. The study is listed as single group, with allocation not applicable and no masking. Although the registry reports dose-group safety counts, it explicitly cautions that the groups are not a like-for-like control comparison. There is no randomized comparator in the record, so differences between the groups cannot be attributed to dose or treatment without additional design and analysis information.
The registry lists 3 participants at risk in the Dose1.4mg/kg group and 42 at risk in the Dose 1.8mg/kg group for serious adverse events. It reports 3 participants affected in the former group and 37 in the latter. For other adverse events, the registry reports 3 affected among 3 at risk in the Dose1.4mg/kg group and 28 affected among 42 at risk in the Dose 1.8mg/kg group. These are descriptive counts. They do not establish whether events were caused by treatment, and the record does not give enough information to interpret them as a formal comparison between dose levels.
The death counts are 2 in each dose group. The registry entries do not give cause of death, timing, relationship to treatment, or a definition linking these counts to the primary endpoint. These figures should therefore be read only as reported counts, not as evidence about cause or comparative risk.
The primary endpoint is defined as the number of eligible patients with grade 3 or higher adverse events during 13 months from first dose. Its observed count is not reported in the registry record. Serious adverse-event counts are not interchangeable with that endpoint: seriousness and severity grading are distinct concepts, and the registry does not establish that the adverse-event summaries correspond to the endpoint's definition or timeframe.
The record lists response-related secondary outcomes but does not provide their results in the registry record. Consequently, no response rate, treatment effect, or precision estimate for response can be described. The study purpose includes assessing how well the combination works, but a stated aim is not itself an outcome result. Statistical interpretation should remain limited to the study design, endpoint definition, and safety counts actually recorded.
There are no statistical analysis records listed. The registry therefore does not report inferential tests, confidence intervals, adjustment for covariates, or a formal analysis comparing the dose groups. In general, a confidence interval describes uncertainty around an estimate; without a reported estimate and interval for an outcome, precision cannot be evaluated from the registry record. The posted counts remain useful as descriptive information, but they do not resolve the missing primary endpoint result or establish causal effects.
9. Statistical Methods Explained
Reading this study statistically begins with its design. The registry identifies a phase 1/2, single-group study, with allocation listed as not applicable and masking listed as none. In general, random allocation helps make treatment groups comparable on average, including on factors that are not measured. That feature is not described for this study. The registry’s two dose-group labels therefore do not create randomized control arms. Any difference in reported counts across those groups could reflect differences in who entered each group, follow-up, or other factors, and the record does not report methods for separating those possibilities.
What does the primary endpoint count?
The endpoint is a participant-level count: eligible patients who experienced grade 3 or higher adverse events under NCI CTCAE Version 4.0 during Phase 1 and Phase 2. The endpoint timeframe is 13 months from first dose. In general, a participant-level outcome records whether each person met a defined condition, rather than counting every occurrence of that condition. That distinction matters because one participant may have more than one event, but a participant count does not become an event count merely because multiple events occurred.
The primary population description names N=45 eligible patients and says one patient was ineligible because the interval between disease evaluation and entry exceeded the prescribed interval. The registry reports total enrollment of 46. Those figures describe different populations in the record and should not be conflated. The primary endpoint’s actual event count is not reported in the registry record, so neither the number meeting the endpoint nor its uncertainty can be assessed.
How should the dose groups be read?
The registry gives safety counts for Dose1.4mg/kg and Dose 1.8mg/kg. For each, it lists the number at risk and the number affected for serious and other adverse events. These counts permit a descriptive account of what the registry records in each group. They do not, without randomization or a reported adjustment strategy, support a causal comparison. The record does not report how dose assignment occurred, whether group membership was based on phase or another factor, or whether the groups had comparable follow-up.
In general, comparisons of raw counts can be misleading when groups differ in size or exposure time. A rate may account for a denominator or time at risk, but a valid rate requires a clearly defined population, follow-up, and event ascertainment. The registry entries list participants at risk and affected, but do not report person-time or a formal rate analysis. No new rate or contrast should be inferred from these records.
What do the analysis fields establish?
The record lists no statistical analysis records. This means that no inferential analysis is described in the information available: a test, confidence interval, adjusted model, or prespecified contrast is not reported. In general, a confidence interval communicates the uncertainty associated with an estimate under a particular analysis. A p-value, when reported, summarizes how compatible data are with a specified null model under its assumptions. Neither can be reconstructed reliably without the relevant outcome data and analysis specification.
The registry includes a planning illustration assumption: two-sided significance level 0.05, equal allocation between two arms, and a normal approximation, with the detectable effect set as a stated fraction of the observed effect. The description says that time-to-event illustrations use a total event count, while other illustrations use participants per arm. These are planning assumptions, not evidence that the trial was designed or analyzed that way. In particular, the equal-allocation, two-arm illustration is not the reported single-group trial design. Sample-size illustrations are planning scenarios, not observed power, and no illustrated sample-size result is reported in the registry record.
Why can over-dispersion matter?
In general, over-dispersion occurs when observed variability exceeds what a statistical model assumes. It can make uncertainty estimates too small if the model does not account for the extra variation. This concept is relevant to count outcomes in some settings, but the registry record does not report an over-dispersion assessment or a model for these adverse-event counts. No particular modeling approach should be attributed to the study.
More broadly, outcome definitions and follow-up windows must align before estimates can be compared. The primary endpoint uses a specified severity threshold and 13-month timeframe. The safety counts also distinguish serious adverse events from other adverse events, but the record does not state that their definitions or observation periods match the primary endpoint. The reported list of serious-event terms gives percentages, but the population or denominator behind those percentages is not reported in the registry record. These limits prevent a fuller reanalysis or comparison from the recorded details alone.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists nine outcome measures and no statistical analysis records. It does not report which outcome was tested first, whether a hierarchy of outcomes was prespecified, or whether any multiplicity adjustment was planned. In general, examining multiple outcomes can increase the chance of at least one apparently notable finding when each is tested separately. Adjustment or a prespecified testing strategy can address that concern, but neither is reported in the registry record. No claims about statistical significance across outcomes can therefore be made from the available information.
Missing-data procedures are not reported in the registry record. It does not state how incomplete adverse-event follow-up, withdrawals, unavailable assessments, or missing response data were handled. The primary endpoint population description specifies eligible patients and explains the ineligibility of one patient, but it does not describe a broader analysis-population rule or the handling of missing endpoint status. The registry record also does not provide the observed primary endpoint count.
Analysis populations are consequently only partly described. The primary outcome definition refers to eligible patients, while safety counts are presented separately by dose group with participants at risk and affected. The record does not explain how those safety populations were defined or whether every eligible patient was included in each outcome summary. Nor does it report analysis exclusions, imputation, censoring rules, or sensitivity analyses. These omissions matter because the interpretation of a count depends on who was assessed and how missing observations were treated. Without those details, the registry supports descriptive reading of the listed counts but not a reconstruction of the intended analysis.
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 |
|---|---|---|---|
| Dose1.4mg/kg | 3 | 3 | 100.0% |
| Dose 1.8mg/kg | 37 | 42 | 88.1% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dose1.4mg/kg | 2 of 3 |
| Dose 1.8mg/kg | 2 of 42 |
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 |
|---|---|
| Dose1.4mg/kg | 3 of 3 |
| Dose 1.8mg/kg | 28 of 42 |
Most frequent serious adverse event terms
| Event term | Organ system | Dose1.4mg/kg | Dose 1.8mg/kg |
|---|---|---|---|
| Neutrophil count decreased | Investigations | 3 of 3 | 28 of 42 |
| White blood cell decreased | Investigations | 3 of 3 | 15 of 42 |
| Alanine aminotransferase increased | Investigations | 1 of 3 | 13 of 42 |
| Platelet count decreased | Investigations | 0 of 3 | 13 of 42 |
| Aspartate aminotransferase increased | Investigations | 1 of 3 | 10 of 42 |
| Lymphocyte count decreased | Investigations | 3 of 3 | 8 of 42 |
| Anemia | Blood and lymphatic system disorders | 1 of 3 | 4 of 42 |
| Hypotension | Vascular disorders | 0 of 3 | 4 of 42 |
| Diarrhea | Gastrointestinal disorders | 0 of 3 | 3 of 42 |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 0 of 3 | 3 of 42 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dose1.4mg/kg | Dose 1.8mg/kg |
|---|---|---|---|
| Rash maculo-papular | Skin and subcutaneous tissue disorders | 1 of 3 | 12 of 42 |
| Nausea | Gastrointestinal disorders | 3 of 3 | 9 of 42 |
| Aspartate aminotransferase increased | Investigations | 2 of 3 | 10 of 42 |
| Alanine aminotransferase increased | Investigations | 2 of 3 | 9 of 42 |
| Vomiting | Gastrointestinal disorders | 2 of 3 | 8 of 42 |
| Fatigue | General disorders | 2 of 3 | 8 of 42 |
| Fever | General disorders | 1 of 3 | 8 of 42 |
| Headache | Nervous system disorders | 2 of 3 | 7 of 42 |
| Platelet count decreased | Investigations | 3 of 3 | 5 of 42 |
| Anemia | Blood and lymphatic system disorders | 1 of 3 | 6 of 42 |
Serious events with the highest arm-level rate: lymphocyte count decreased (100.0%), neutrophil count decreased (100.0%), white blood cell decreased (100.0%), anemia (33.3%), alanine aminotransferase increased (33.3%).
The safety record gives serious adverse-event counts by dose group. In Dose1.4mg/kg, 3 participants were at risk and 3 were affected. In Dose 1.8mg/kg, 42 were at risk and 37 were affected. For other adverse events, 3 were affected among 3 at risk in Dose1.4mg/kg, and 28 were affected among 42 at risk in Dose 1.8mg/kg. These are participant counts, not counts of every event episode.
The registry also lists deaths as 2 for each group. It does not report causes, timing, treatment relationship, or whether these deaths are included in any other safety category. They should not be interpreted as treatment-related deaths from the counts alone.
Serious adverse events and grade 3 or higher adverse events are not interchangeable categories. The primary endpoint uses a severity threshold, while the safety listing distinguishes serious events from other events. The registry does not report whether the serious-event summaries use the primary endpoint’s timeframe. It lists serious-event terms including lymphocyte count decreased, neutrophil count decreased, white blood cell decreased, anemia, alanine aminotransferase increased, and aspartate aminotransferase increased. The accompanying percentages are reported as 100.0% and 33.3%, but their denominator and grouping are not reported in the registry record. The counts are descriptive and are not a randomized comparison.
12. What the Result Does, and Does Not, Mean
The registry record documents a phase 1/2 study of brentuximab vedotin combined with gemcitabine hydrochloride in younger patients with relapsed or refractory Hodgkin lymphoma. It describes the treatment schedule, identifies the primary safety endpoint, and reports adverse-event counts for two dose groups. Those details can help readers understand what was studied and what types of safety information the registry records.
The record does not report the observed result for the primary endpoint: the number of eligible patients with grade 3 or higher adverse events during 13 months from first dose. It also does not report results for the listed response-related secondary outcomes in the registry record. Therefore, the record does not establish a response estimate or the precision of any efficacy estimate. The study’s stated purpose of assessing how well the combination works should not be mistaken for a reported efficacy result.
The dose-group safety counts are not evidence from a randomized dose comparison. The registry identifies a single-group design, and no random allocation is reported. The two groups may not be comparable in ways that matter to outcomes, and the registry does not provide an adjustment analysis. The counts also do not establish that the treatment caused any event or death. Such conclusions require more information about event definitions, timing, attribution, follow-up, and the analysis population.
In general, a registry entry is a record of study design and posted outcomes, not a substitute for a fully reported analysis. Interpretation depends on complete outcome counts, definitions, handling of missing observations, and statistical methods. The registry record does not report several of these details. Its figures should be read as descriptive registry information rather than as proof of benefit, lack of benefit, or comparative safety.
13. Why This Trial Matters Statistically
This study illustrates why design labels matter when reading clinical results. The registry records dose groups, but identifies the study as single group, with allocation not applicable. A reader might otherwise mistake the two dose labels for treatment and control arms. Recognizing that they are not a like-for-like randomized comparison prevents descriptive differences from being read as causal effects.
It also demonstrates why an endpoint’s definition must be kept distinct from related safety summaries. The primary endpoint counts eligible participants with grade 3 or higher adverse events under a specified grading system and timeframe. The registry separately lists serious and other adverse-event counts. Seriousness and severity are different ways of classifying events, so one cannot be substituted for the other without evidence that the definitions align. The primary endpoint result itself is not reported in the registry record.
The entry also makes the limits of registry-level interpretation visible. The record provides enrollment, eligibility information, treatment schedules, and descriptive safety counts, but no statistical analysis records. It does not report missing-data methods, formal group comparisons, or the observed response results listed among secondary outcomes. The planning assumptions use a two-arm illustration, while the design is recorded as single group; that distinction is important because planning scenarios should not be confused with the study’s actual design or with observed power.
For biostatisticians and clinical researchers, these features underscore the value of clear population definitions, prespecified analysis plans, transparent reporting of outcome denominators, and explicit treatment of missing data. Without those elements, even exact counts may answer only a limited descriptive question. The record supports careful description of what it reports while leaving important questions about primary outcome results and comparative inference unanswered.
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 registry record provides limited information for assessing the study’s primary endpoint. It defines the endpoint and timeframe, and identifies the eligible population as N=45, but does not report the number of patients who met the endpoint. The serious adverse-event counts cannot fill that gap because the record does not establish that they use the same grade threshold, population, or timeframe.
The design is single group and not randomized. Although safety counts are divided between Dose1.4mg/kg and Dose 1.8mg/kg, the process for assigning patients to those groups is not reported. The record does not provide a formal comparison, adjustment for baseline differences, or information on comparable follow-up. As a result, the groups should not be treated as control arms for causal inference.
Details needed to interpret the safety summaries are also absent. The record does not specify causes or treatment relationships for the death counts, and the denominator and group attribution of the listed serious-event percentages are not reported. It does not describe whether the adverse-event counts cover the same period as the primary endpoint, or give a full account of outcome ascertainment.
The registry lists secondary outcomes but no results for them in the registry record. It also lists no statistical analysis records, and does not report multiplicity procedures, missing-data handling, analysis-population rules beyond the primary endpoint’s eligible population, or sensitivity analyses. The regimen description is truncated after beginning a condition for patients with complete response, so the full treatment-stopping description is unavailable in the registry record. These limitations constrain both reproducibility and interpretation.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Brentuximab Vedotin and Gemcitabine Hydrochloride in Treating Younger Patients With Relapsed or Refractory Hodgkin Lymphoma — NCT01780662.
- Registry record last updated 2021-10-28; status last verified 2021-10.
- Results first posted 2019-10-01.
- 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.
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18. Record Summary
NCT01780662 is a completed phase 1/2, single-group study sponsored by the National Cancer Institute. It evaluated brentuximab vedotin with gemcitabine hydrochloride in younger patients with relapsed or refractory Hodgkin lymphoma. The registry reports enrollment of 46 and identifies 45 eligible patients for the primary endpoint description, noting that one patient was ineligible.
The primary endpoint counted eligible participants with grade 3 or higher adverse events under NCI CTCAE Version 4.0 during 13 months from first dose. Its observed result is not reported in the registry record. Safety counts are listed for Dose1.4mg/kg and Dose 1.8mg/kg, but the groups are not randomized comparison arms. The record lists nine outcome measures and no statistical analysis records. It does not report results for the response-related secondary outcomes or describe missing-data and multiplicity methods. Interpretation is therefore limited to the design, endpoint definition, and descriptive safety figures recorded.