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 A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma (NCT00343564), a non-randomized phase 1, phase 2 study. The primary outcome is Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF..
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00343564 |
| Phase | Phase 1, Phase 2 |
| Condition | Non-Hodgkin's Lymphoma, Hodgkin's Disease |
| Allocation | Non-Randomized |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 68 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Cytokinetics |
| Results posted | Yes |
2. Clinical Question
Population
Patients with non-Hodgkin lymphoma or Hodgkin lymphoma were eligible for the Phase I study. The registry lists enrollment of 68. The primary endpoint population is described as the safety population: patients who received at least one dose of study drug. The record also defines an efficacy-evaluable population as patients who received both cycles of treatment.
Intervention
SB-743921 was administered intravenously. The official title describes dosing on Days 1 and 15 of a 28-day schedule. Phase I tested increasing doses, first without and then with prophylactic G-CSF. The registry describes the planned Phase II dose as fixed, based on Phase I findings.
Comparator
There was no randomized comparator. The study was non-randomized and used a single-group model. Dose cohorts and G-CSF status describe stages of dose escalation, not like-for-like control groups.
Primary question
In Phase I, what was the maximum tolerated dose, determined by testing increasing doses in cohorts with at least 3 patients each? The registry defines this as the highest dose that did not cause dose-limiting toxicity. The MTD result itself is not reported in the registry record.
3. Trial Design
This was a Phase I-II study of SB-743921 in non-Hodgkin lymphoma and Hodgkin lymphoma. The registry lists the trial as completed, with enrollment of 68, a start date of 2006-04, and primary completion in 2010-07. It was non-randomized, unmasked, and described as a single-group study. Those features mean the dose groups should not be treated as randomized treatment arms or as controlled comparisons.
The Phase I portion was a dose-escalation study intended to assess safety and tolerability and identify the maximum tolerated dose. Dose escalation was described as testing increasing doses in cohorts with at least 3 patients each. The arm descriptions distinguish dose levels administered without G-CSF from levels administered with G-CSF. The registry does not report the rules used to decide when to escalate or stop escalation.
The official title describes intravenous administration on Days 1 and 15 of a 28-day dosing schedule. The Phase II portion was intended to assess activity, safety, and tolerability in patients with indolent and aggressive non-Hodgkin lymphomas, with a fixed dose based on Phase I findings and stratification by lymphoma type. The brief summary states that Phase II was not initiated. Therefore, the listed Phase II plan is not evidence that those patients were enrolled or that Phase II outcomes were measured.
The registry lists pharmacokinetic outcomes for Day 1 and Day 15, including Cmax, Tmax, Clast, and AUClast. These are secondary outcomes, distinct from the Phase I primary question about dose-limiting toxicity and MTD.
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.
Only the first 6 of 11 groups are shown.
Overall Study
| Stage | 2 mg/m2 Without GCSF | 3 mg/m2 Without GCSF | 4 mg/m2 Without GCSF | 5 mg/m2 Without GCSF | 6 mg/m2 Without GCSF | 7 mg/m2 Without GCSF |
|---|---|---|---|---|---|---|
| STARTED | 6 | 7 | 3 | 7 | 10 | 9 |
| COMPLETED | 6 | 7 | 3 | 7 | 10 | 9 |
| NOT COMPLETED | 0 | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: Safety population; all patients who received at least 1 dose of study drug were included in the intent-to-treat/safety populations. Efficacy evaluable; any patient who received both cycles of treatment.
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.
Only the first 6 of 12 groups are shown.
| Characteristic | Unit | 2 mg/m2 Without GCSF | 3 mg/m2 Without GCSF | 4 mg/m2 Without GCSF | 5 mg/m2 Without GCSF | 6 mg/m2 Without GCSF | 7 mg/m2 Without GCSF |
|---|---|---|---|---|---|---|---|
| Participants analysed | 6 | 7 | 3 | 7 | 10 | 9 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 | 0 | 1 |
| Age, Categorical: Between 18 and 65 years | Participants | 4 | 7 | 3 | 3 | 8 | 6 |
| Age, Categorical: >=65 years | Participants | 2 | 0 | 0 | 4 | 2 | 2 |
| Age, Continuous | years | 62 (SD 9) | 43 (SD 13) | 33 (SD 9) | 57 (SD 22) | 48 (SD 16) | 42 (SD 24) |
| Sex: Female, Male: Female | Participants | 4 | 6 | 1 | 2 | 4 | 4 |
| Sex: Female, Male: Male | Participants | 2 | 1 | 2 | 5 | 6 | 5 |
| Region of Enrollment: United States | participants | 6 | 4 | 1 | 5 | 7 | 6 |
| Region of Enrollment: Russian Federation | participants | 0 | 3 | 2 | 2 | 3 | 3 |
6. Primary Endpoint
The registry lists the primary outcome as Phase 1: Determination of Maximum Tolerated Dose (MTD) First Without and Then With Administration of Prophylactic G-CSF., measured over 28 days.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | mg/m2 |
| Endpoint classification | not reduced to a single comparison |
The primary endpoint is Phase I determination of the maximum tolerated dose, first without and then with prophylactic G-CSF. It is expressed in mg/m2, and its stated timeframe is 28 days. The registry describes the MTD as the highest dose that did not cause dose-limiting toxicity, after testing increasing doses in cohorts with at least 3 patients each. The specific criteria for classifying a toxicity as dose-limiting are not reported in the registry record.
This endpoint serves a different purpose from an efficacy outcome. In an early-phase dose-escalation study, identifying a tolerable dose range is a way to guide later evaluation of a dose; it does not establish whether treatment improves a clinical outcome. The endpoint also makes the order and context of dosing important: the registry describes escalation without G-CSF followed by escalation with prophylactic G-CSF.
The registry does not report the resulting MTD value, the dose-limiting toxicity findings used to determine it, or a numerical primary endpoint result. Accordingly, the endpoint definition can be described, but a conclusion about the dose selected cannot be drawn from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The record describes a dose-finding study rather than a randomized test of SB-743921 against another treatment. The central Phase I question was the MTD, based on dose-limiting toxicity in successive cohorts. The primary endpoint is defined, but its numerical result is not reported in the registry record. Without that result, the endpoint cannot be interpreted as establishing a selected MTD or a dose-response pattern.
The posted safety figures are organized by dose and G-CSF status. For example, the record lists serious adverse events affecting 2 of 5 patients in the 2 mg/m2 without-GCSF group, and 3 of 10 in the 6 mg/m2 without-GCSF group. These are descriptive counts within individual cohorts. The groups were not randomized, and the dose levels were part of escalation; they are not comparable control groups. Differences between their counts cannot be interpreted as causal dose effects.
The registry also lists other adverse events affecting all patients in several cohorts, with 8 of 9 affected in the 7 mg/m2 without-GCSF group. These counts should be read as cohort-level descriptions, not as evidence that a dose was safer or less safe than another. The record does not provide a randomized comparison, and the adverse-event figures alone do not establish a treatment effect.
The planned Phase II assessment of activity, safety, and tolerability in indolent and aggressive non-Hodgkin lymphoma was not initiated. As a result, the Phase II plan cannot support conclusions about activity in those populations. The registry lists nine outcome measures and zero analyses, but does not provide a numerical result for the primary MTD endpoint. Pharmacokinetic outcomes are listed, but their numerical results are not reported in the registry record.
General statistical interpretation: confidence intervals, when reported, describe the uncertainty around an estimate under the assumptions of the analysis. No confidence interval or inferential comparison is reported for the primary endpoint in this record. The dose-cohort safety counts are therefore best read descriptively, with attention to the small cohort sizes and the absence of a like-for-like comparator.
9. Statistical Methods Explained
The registry describes a non-randomized, unmasked, single-group Phase I-II study. These design labels shape what the results can address. Without random allocation to comparable groups, variation between dose cohorts may reflect differences in who entered each cohort, the sequence of dose escalation, or the use of G-CSF, as well as dose itself. The record does not support treating the cohorts as a randomized comparison.
What does dose escalation mean?
In general, dose escalation tests progressively higher doses in cohorts while monitoring tolerability. The trial description says that increasing doses were tested in cohorts with at least 3 patients each. The objective was to identify the MTD, defined in the record as the highest dose that did not cause dose-limiting toxicity. The specific escalation decision rules and the criteria for dose-limiting toxicity are not reported in the registry record, so the process cannot be reconstructed from the endpoint definition alone.
The Phase I arm descriptions distinguish dosing without G-CSF and dosing with G-CSF support. The primary endpoint title says that MTD was determined first without and then with prophylactic G-CSF. Because G-CSF status and dose level change across the escalation sequence, comparisons across those groups do not isolate the effect of either factor. The registry does not report a statistical model adjusting for these differences.
How should a cohort count be read?
General explanation: a count of patients with an event describes how many people in a defined group were recorded as affected. Its interpretation depends on the group denominator, the event definition, the observation period, and how missing observations were handled. In this record, adverse-event counts are given by dose cohort, with at-risk and affected counts. They are descriptive safety summaries, not estimates from a randomized treatment contrast.
For serious adverse events, the record gives counts by cohort, such as 0 of 6 in the 3 mg/m2 without-GCSF group and 3 of 7 in the 10 mg/m2 with-GCSF group. A count of zero in a small cohort does not establish that the event risk is absent; it means no affected patients were recorded in that cohort in the posted figures. The record does not report confidence intervals for these counts. The serious-event term percentages are also listed, but the denominators underlying those percentages are not reported in the registry record.
What does the MTD endpoint not establish?
General explanation: an MTD is a dose-finding measure based on a specified toxicity rule, not a measure of efficacy. Even when an MTD is identified, it does not by itself establish a benefit in patients or determine how a treatment compares with another option. In this record, the MTD value and the dose-limiting toxicity results are not reported, so even the dose-finding result cannot be assessed.
The registry lists pharmacokinetic outcomes for Cmax, Tmax, Clast, and AUClast on Day 1 and Day 15. In general, pharmacokinetic measures describe aspects of drug concentration over time or drug exposure. Their numerical estimates and analysis details are not reported in the registry record, so no conclusion about the observed pharmacokinetic profile can be drawn from the outcome labels alone.
What statistical analysis is available?
The registry record lists nine outcome measures and zero analyses. It does not report a statistical model, hypothesis test, adjustment method, uncertainty interval, or analysis plan for the MTD endpoint. The stated cohort design and endpoint definition should not be mistaken for a complete statistical analysis plan. General explanation: when estimates and uncertainty measures are absent, descriptive counts can still characterize what was recorded, but they do not quantify the precision of a treatment comparison.
The record lists enrollment of 68, but does not say how many patients received at least one dose, completed both cycles, or contributed to each specific endpoint. The population definitions identify who was intended for safety and efficacy-evaluable analyses; they do not give the number analyzed. No sample-size justification is reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists a Phase I primary endpoint and secondary pharmacokinetic outcomes for Day 1 and Day 15. It does not report how multiple outcomes or repeated pharmacokinetic measures were handled statistically. Any multiplicity adjustment, hierarchy of testing, or distinction between confirmatory and exploratory analyses is not reported in the registry record. The presence of several listed outcomes does not by itself show that formal hypothesis tests were conducted.
The record lists nine outcome measures and zero analyses. It does not provide endpoint estimates, confidence intervals, p-values, or a statistical analysis plan for the primary endpoint. Interim analyses and stopping rules beyond the general dose-escalation purpose are not reported in the registry record.
The primary endpoint population is described as the safety population: patients who received at least one dose of study drug were included in the intent-to-treat/safety populations. The efficacy-evaluable population is described as any patient who received both cycles of treatment. The registry does not state how missing measurements, incomplete treatment, or patients excluded from an analysis were handled. It also does not report the number of patients in either population.
General explanation: missing outcome data can affect interpretation when the chance of a missing value is related to a patient's health, treatment exposure, or outcome. Without information about the amount and handling of missing data, the direction or size of any resulting bias cannot be assessed. No assumptions about missingness or imputation should be attributed to this study based on the registry record.
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 |
|---|---|---|---|
| 2 mg/m2 Without GCSF | 2 | 5 | 40.0% |
| 3 mg/m2 Without GCSF | 0 | 6 | 0.0% |
| 4 mg/m2 Without GCSF | 0 | 3 | 0.0% |
| 5 mg/m2 Without GCSF | 0 | 6 | 0.0% |
| 6 mg/m2 Without GCSF | 3 | 10 | 30.0% |
| 7 mg/m2 Without GCSF | 1 | 9 | 11.1% |
| 6 mg/m2 With GCSF | 1 | 4 | 25.0% |
| 7 mg/m2 With GCSF | 1 | 3 | 33.3% |
| 8 mg/m2 With GCSF | 0 | 3 | 0.0% |
| 9 mg/m2 With GCSF | 1 | 7 | 14.3% |
| 10 mg/m2 With GCSF | 3 | 7 | 42.9% |
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 |
|---|---|
| 2 mg/m2 Without GCSF | 5 of 5 |
| 3 mg/m2 Without GCSF | 6 of 6 |
| 4 mg/m2 Without GCSF | 3 of 3 |
| 5 mg/m2 Without GCSF | 6 of 6 |
| 6 mg/m2 Without GCSF | 10 of 10 |
| 7 mg/m2 Without GCSF | 8 of 9 |
Most frequent serious adverse event terms
| Event term | Organ system | 2 mg/m2 Without GCSF | 3 mg/m2 Without GCSF | 4 mg/m2 Without GCSF | 5 mg/m2 Without GCSF | 6 mg/m2 Without GCSF | 7 mg/m2 Without GCSF |
|---|---|---|---|---|---|---|---|
| Sepsis | Infections and infestations | 0 of 5 | 0 of 6 | 0 of 3 | 0 of 6 | 1 of 10 | 0 of 9 |
| Clostridium infection | Infections and infestations | 0 of 5 | 0 of 6 | 0 of 3 | 0 of 6 | 1 of 10 | 0 of 9 |
| Pneumonia | Infections and infestations | 0 of 5 | 0 of 6 | 0 of 3 | 0 of 6 | 1 of 10 | 0 of 9 |
| Neutropenia | Blood and lymphatic system disorders | 0 of 5 | 0 of 6 | 0 of 3 | 0 of 6 | 1 of 10 | 0 of 9 |
| Anaemia | Blood and lymphatic system disorders | 0 of 5 | 0 of 6 | 0 of 3 | 0 of 6 | 0 of 10 | 1 of 9 |
| Haemolytic anaemia | Blood and lymphatic system disorders | 1 of 5 | 0 of 6 | 0 of 3 | 0 of 6 | 0 of 10 | 0 of 9 |
| Heparin-induced thrombocytopenia | General disorders | 0 of 5 | 0 of 6 | 0 of 3 | 0 of 6 | 1 of 10 | 0 of 9 |
| Dehydration | Metabolism and nutrition disorders | 0 of 5 | 0 of 6 | 0 of 3 | 0 of 6 | 1 of 10 | 0 of 9 |
| Hyperbilirubinaemia | Hepatobiliary disorders | 0 of 5 | 0 of 6 | 0 of 3 | 0 of 6 | 0 of 10 | 1 of 9 |
| Procedural hypotension | Injury, poisoning and procedural complications | 1 of 5 | 0 of 6 | 0 of 3 | 0 of 6 | 0 of 10 | 0 of 9 |
Most frequent non-serious adverse event terms
| Event term | Organ system | 2 mg/m2 Without GCSF | 3 mg/m2 Without GCSF | 4 mg/m2 Without GCSF | 5 mg/m2 Without GCSF | 6 mg/m2 Without GCSF | 7 mg/m2 Without GCSF |
|---|---|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders | 0 of 5 | 1 of 6 | 1 of 3 | 5 of 6 | 5 of 10 | 7 of 9 |
| Fatigue | General disorders | 3 of 5 | 2 of 6 | 2 of 3 | 1 of 6 | 1 of 10 | 4 of 9 |
| Anaemia | Blood and lymphatic system disorders | 1 of 5 | 1 of 6 | 0 of 3 | 1 of 6 | 4 of 10 | 2 of 9 |
| Pyrexia | General disorders | 1 of 5 | 2 of 6 | 1 of 3 | 0 of 6 | 2 of 10 | 3 of 9 |
| Hyperglycaemia | Metabolism and nutrition disorders | 1 of 5 | 1 of 6 | 0 of 3 | 1 of 6 | 4 of 10 | 1 of 9 |
| Nausea | Gastrointestinal disorders | 1 of 5 | 2 of 6 | 0 of 3 | 0 of 6 | 3 of 10 | 1 of 9 |
| Thrombocytopenia | Blood and lymphatic system disorders | 1 of 5 | 0 of 6 | 0 of 3 | 2 of 6 | 1 of 10 | 2 of 9 |
| Diarrhoea | Gastrointestinal disorders | 2 of 5 | 2 of 6 | 0 of 3 | 1 of 6 | 0 of 10 | 1 of 9 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 5 | 2 of 6 | 0 of 3 | 0 of 6 | 2 of 10 | 1 of 9 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 1 of 5 | 1 of 6 | 0 of 3 | 1 of 6 | 1 of 10 | 2 of 9 |
Serious events with the highest arm-level rate: pneumococcal bacteraemia (33.3%), renal failure acute (25.0%), haemolytic anaemia (20.0%), procedural hypotension (20.0%), malignant plural effusion (20.0%).
The safety figures report serious adverse events by dose cohort, with the number at risk and the number affected. For example, the registry lists 1 of 4 affected in the 6 mg/m2 with-GCSF group and 0 of 3 in the 8 mg/m2 with-GCSF group. These are cohort-specific descriptive counts. The small groups and non-randomized dose-escalation design mean they should not be read as a controlled comparison of doses or G-CSF status.
The record lists serious adverse event terms with percentages, including pneumococcal bacteraemia at 33.3%, renal failure acute at 25.0%, and haemolytic anaemia at 20.0%. The denominators and calculation details for those term percentages are not reported in the registry record, so the percentages should not be combined or used to infer a participant-level risk across the study.
Other adverse events affected all patients in several dose cohorts, according to the posted counts. The death values are null in the record; death counts are therefore not reported in the registry record. These summaries describe recorded events and do not establish that SB-743921 caused them or that their frequency differs from another treatment.
12. What the Result Does, and Does Not, Mean
The registry record documents a completed early-phase trial with a Phase I dose-escalation component and a planned Phase II component. The Phase I primary question was how to determine the MTD of SB-743921, first without and then with prophylactic G-CSF. The endpoint definition and cohort-level safety figures provide context for that question, but the numerical MTD result is not reported in the registry record.
The brief summary states that Phase II was not initiated. Therefore, the planned Phase II assessment of activity, safety, and tolerability in indolent and aggressive non-Hodgkin lymphoma did not yield a result in this trial record. The fact that efficacy was part of the Phase II plan is not evidence of efficacy findings.
The adverse-event counts give descriptive information for the listed cohorts. Because the study was not randomized and had no like-for-like control group, these data do not establish comparative risks or effects attributable to dose or G-CSF. The term percentages also lack reported denominators in the registry record, limiting their interpretation.
General explanation: a trial's design and outcome data determine the claims its results can support. A dose-escalation study can address tolerability and dose selection when its decision rules and results are reported; it is not, by itself, a controlled estimate of treatment benefit. Here, the registry describes the intended dose-finding approach but does not report the primary numerical result, statistical uncertainty, or Phase II findings. Conclusions should therefore remain limited to the study's recorded design and descriptive safety information.
13. Why This Trial Matters Statistically
This study illustrates a basic distinction in clinical research: identifying a dose and evaluating clinical activity are different questions. The Phase I endpoint concerned the maximum tolerated dose, defined through dose-limiting toxicity. The planned Phase II portion would have assessed activity, safety, and tolerability in indolent and aggressive non-Hodgkin lymphoma, but it was not initiated. Treating the planned Phase II aims as observed outcomes would confuse protocol intent with results.
The design also shows why dose cohorts should not be interpreted like randomized arms. Dose levels were used in an escalation sequence, and the record separately describes cohorts with and without G-CSF. Without randomization or a control group, the cohort counts cannot isolate the effect of dose, G-CSF, or treatment relative to another option.
The record lists a primary endpoint definition and adverse-event summaries, but no numerical MTD result or analyses. This gap matters statistically: a clearly described endpoint does not tell readers what was observed, while descriptive counts without uncertainty estimates do not quantify precision. The distinction between a registry's intended outcomes and its posted results is essential when assessing what a trial can establish.
General explanation: careful interpretation depends on matching a claim to the design and the reported analysis. Here, the most defensible statistical reading is about the structure of the dose-escalation study and the limits of its recorded summaries, not about comparative efficacy.
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 does not report the numerical MTD result, dose-limiting toxicity counts, or criteria used to classify a toxicity as dose-limiting. This prevents readers from evaluating the primary dose-finding result or reconstructing the escalation decisions.
The trial was non-randomized, unmasked, and described as a single-group study. The dose cohorts are not like-for-like control groups, and no comparator treatment is listed. Cohort-level adverse-event counts therefore cannot establish comparative safety or attribute differences to dose or G-CSF.
The planned Phase II portion was not initiated, so the trial record does not provide the intended Phase II assessment in indolent and aggressive non-Hodgkin lymphoma. Numerical results for the listed pharmacokinetic outcomes are not reported in the registry record. The record also does not report inferential analyses, uncertainty intervals, missing-data handling, multiplicity procedures, or a sample-size justification.
Although enrollment is listed as 68, the numbers contributing to the safety population, efficacy-evaluable population, and individual outcomes are not reported in the registry record. The underlying denominators for the serious adverse event term percentages are also not reported. These omissions limit evaluation of precision and completeness. The record does not provide enough information to infer unreported results or explain why Phase II was not initiated.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Study of SB-743921 in Non-Hodgkin Lymphoma and Hodgkin Lymphoma — NCT00343564.
- Registry record last updated 2020-01-13; status last verified 2020-01.
- Results first posted 2016-10-04.
- 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.
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18. Record Summary
NCT00343564 is a completed, non-randomized, unmasked Phase I-II study of SB-743921 in patients with non-Hodgkin lymphoma and Hodgkin lymphoma. The registry lists enrollment of 68. The Phase I portion tested increasing doses, first without and then with prophylactic G-CSF, to determine the maximum tolerated dose. The primary endpoint is defined as the highest dose that did not cause dose-limiting toxicity, with a 28-day timeframe.
The registry lists serious and other adverse-event counts by dose cohort, along with secondary pharmacokinetic outcomes for Day 1 and Day 15. The numerical MTD result and pharmacokinetic results are not reported in the registry record. The planned Phase II portion was not initiated. The available figures are descriptive and do not form a randomized comparison or establish treatment efficacy.