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 Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer (NCT00192075), a randomized phase 2 study. The primary outcome is Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00192075 |
| Phase | Phase 2 |
| Condition | Colorectal Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 84 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Eli Lilly and Company |
| Results posted | Yes |
2. Clinical Question
Population
Patients with metastatic colorectal cancer. The primary outcome specifies the Intent-to-Treat Population, but the registry record does not report further eligibility criteria or the number included in that population.
Intervention
Avastin plus gemcitabine plus 5-fluorouracil (5FU)/folinic acid, abbreviated A+FFG in the arm description.
Comparator
Avastin plus oxaliplatin plus 5-fluorouracil (5FU)/folinic acid, abbreviated A+FOLFOX 4 in the arm description.
Primary question
How does tumor response, classified using RECIST, appear in the two treatment groups? The registry record does not reduce the primary outcome to one reported comparison or give category-specific response counts.
The study summary says its purpose was to describe tumor response rates for the two regimens and to examine survival, time without disease progression or return, duration of response, and side effects or toxicities. The listed secondary outcomes are Time to Progressive Disease, Progression-Free Survival, Overall Survival, and Duration of Response. No numerical results for those outcomes are reported in the registry record.
The central statistical question is therefore defined by the randomized treatment comparison and the RECIST response categories, rather than by a reported estimate of how much one regimen differed from the other. Without category counts or a specified contrast, the registry record does not establish the direction or size of a response difference. The study description identifies the treatment groups and intended outcomes, but those design details alone do not answer the clinical question.
3. Trial Design
This was a multicenter, randomized phase II trial with a parallel-group design and no masking. The registry record lists an enrollment of 84 and a completed status. Eli Lilly and Company is listed as the sponsor, and the study start is recorded as 2003-06. The registry record does not report a completion date or the number of participating centers.
The two assigned regimens shared Avastin and 5FU/folinic acid, while one included gemcitabine and the other included oxaliplatin. The study title and arm descriptions identify the comparison as A+FFG versus A+FOLFOX 4. The summary describes the oxaliplatin-containing regimen as a current standard of care; this is the wording of the registry summary, not a separate statistical finding.
Randomization is stated, but the registry record does not report the randomization sequence method, allocation concealment, or the ratio used to assign participants. The equal allocation assumption described for sample-size planning is not evidence of the actual allocation procedure. The adverse-event record lists 42 participants at risk in each group, but those safety denominators do not by themselves establish how allocation was conducted or whether all enrolled participants entered each analysis.
The trial was unmasked, so participants and study personnel were not blinded according to the registry record. That feature can matter when outcomes involve clinical assessments or reporting, although the record does not describe how response evaluations were conducted or whether assessors were independent. It also does not report treatment doses, treatment duration, adherence, or reasons for discontinuation. The stated primary population is the Intent-to-Treat Population, but the registry record does not give its size or explain how participants with missing assessments were handled.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | A+FFG | A + FOLFOX 4 |
|---|---|---|
| STARTED | 42 | 42 |
| COMPLETED | 3 | 23 |
| NOT COMPLETED | 39 | 19 |
Reasons for not completing this period:
| Reason | A+FFG | A + FOLFOX 4 |
|---|---|---|
| Disease Progression | 23 | 6 |
| Adverse Event | 1 | 3 |
| Death | 0 | 1 |
| Lack of Efficacy | 0 | 0 |
| Physician Decision | 3 | 0 |
| Withdrawal by Subject | 5 | 5 |
| Patient Non-Compliance | 0 | 1 |
| Unacceptable Toxicity Exhibited by Drug | 2 | 1 |
| Other | 5 | 2 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat Population
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 | A+FFG | A + FOLFOX 4 | Total |
|---|---|---|---|---|
| Participants analysed | 42 | 42 | 84 | |
| Age Continuous | years | 62 (28 to 79) | 64 (32 to 81) | 63 (28 to 81) |
| Sex: Female, Male: Female | Participants | 21 | 22 | 43 |
| Sex: Female, Male: Male | Participants | 21 | 20 | 41 |
| Region of Enrollment: United States | participants | 42 | 42 | 84 |
| Diagnosis to Enrollment: <6 months | participants | 29 | 29 | 58 |
| Diagnosis to Enrollment: >=6 months | participants | 13 | 13 | 26 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 - Fully Active | participants | 23 | 20 | 43 |
| Eastern Cooperative Oncology Group (ECOG) Performance Status: 1 - Ambulatory, Restricted Strenuous Activity | participants | 19 | 22 | 41 |
| Primary Tumor Site: Colon | participants | 25 | 35 | 60 |
| Primary Tumor Site: Rectum | participants | 10 | 4 | 14 |
| Primary Tumor Site: Other | participants | 7 | 3 | 10 |
| Prior Adjuvant Therapy: Yes | participants | 12 | 14 | 26 |
| Prior Adjuvant Therapy: No | participants | 30 | 28 | 58 |
| Race/Ethnicity: Caucasian | participants | 33 | 34 | 67 |
| Race/Ethnicity: African descent | participants | 5 | 6 | 11 |
| Race/Ethnicity: Asian | participants | 0 | 1 | 1 |
| Race/Ethnicity: Hispanic | participants | 4 | 1 | 5 |
| Site of Metastasis: Liver | participants | 28 | 29 | 57 |
| Site of Metastasis: Lung | participants | 13 | 11 | 24 |
| Site of Metastasis: Abdominal | participants | 3 | 3 | 6 |
| Site of Metastasis: Regional lymph nodes | participants | 14 | 14 | 28 |
| Site of Metastasis: Distant lymph nodes | participants | 4 | 3 | 7 |
| Site of Metastasis: Genitourinary | participants | 1 | 0 | 1 |
| Site of Metastasis: Other | participants | 8 | 3 | 11 |
| Tumor Stage: Primary tumor | participants | 37 | 41 | 78 |
| Tumor Stage: Regional lymph nodes | participants | 24 | 29 | 53 |
| Tumor Stage: Distant metastasis | participants | 25 | 20 | 45 |
6. Primary Endpoint
The registry lists the primary outcome as Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST), measured over baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years).
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST). It classifies changes in target lesions over time. The registry record defines Complete Response as disappearance of all target lesions, Partial Response as a 30% decrease in the sum of longest diameter of target lesions, Progressive Disease as a 20% increase in that sum, and Stable Disease as changes that do not meet the stated criteria for the other categories.
Response categories are useful because they translate observed changes in tumor measurements into a structured outcome. As a general statistical point, a categorical endpoint can describe how many participants fall into each response class, whereas a single summary contrast requires a prespecified way to combine or compare categories. The registry record does not report such a single contrast, nor does it provide category-specific counts for the two groups.
The stated assessment timeframe runs from baseline to measured progressive disease, with assessments every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years. This repeated assessment schedule makes the timing and completeness of measurement relevant to interpretation. The registry record does not explain how response categories were handled when an assessment was unavailable, or how the response endpoint was summarized across the scheduled visits.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a randomized comparison of two regimens and specifies RECIST tumor response as the primary outcome. It does not report a single primary comparison, category-specific response counts, an effect estimate, or a confidence interval. Consequently, the posted record does not quantify how response differed between the groups or how precisely any difference was estimated. No conclusion about which regimen had a higher response rate can be drawn from the design description alone.
The primary outcome can take several categories: Complete Response, Partial Response, Progressive Disease, and Stable Disease. The registry record gives definitions for those categories, but does not state a single analysis contrast that combines them or identifies one category as the primary comparison. A count or rate for one category would answer a different question from a summary that combines categories. Without the actual counts and the analytic definition, the response comparison remains unspecified in the registry record.
Time to Progressive Disease, Progression-Free Survival, Overall Survival, and Duration of Response are listed as secondary outcomes. Their presence indicates the range of outcomes the study intended to examine, but the registry record does not report estimates, event counts, confidence intervals, or statistical tests for them. It also does not report an analysis plan or analyses. The record lists 11 outcome measures and 0 analyses; those entries do not provide numerical evidence about treatment differences.
The enrollment is 84, and the safety summaries list 42 participants at risk in each group. These details describe the scale of the trial and the denominators used in the adverse-event record; they are not outcome results. The serious adverse-event counts are 11 in A+FFG and 8 in A + FOLFOX 4. Those counts describe recorded participants with serious adverse events, but they do not establish a difference in the overall safety profile or its precision. The record does not report a statistical comparison of adverse events.
As a general statistical point, estimates from a trial are best interpreted alongside uncertainty intervals and a clearly defined analysis population and endpoint contrast. Those pieces are not reported for the primary response comparison in the registry record. The design can explain what was intended to be compared, but in the absence of the outcome results it cannot show the magnitude, direction, or uncertainty of the observed response difference. The record therefore supports a description of the trial question and design, not a conclusion about comparative efficacy.
9. Statistical Methods Explained
The registry record describes a randomized, parallel-group comparison, but it does not report the statistical analysis methods used for the primary outcome. It lists 0 analyses. No test, model, confidence interval method, handling of repeated assessments, or adjustment strategy is reported. The following statistical concepts explain how such outcomes can generally be analyzed; they should not be read as a description of methods actually used in this trial.
What does a categorical response endpoint represent?
RECIST assigns each assessment to a response class using specified tumor-measurement criteria. In this trial description, the categories are Complete Response, Partial Response, Progressive Disease, and Stable Disease. A simple categorical summary would count participants in each class. A rate would use the number in a class relative to a defined analysis population. General statistical practice requires that the denominator and the rule for handling participants without an evaluable assessment be stated. Those details are not reported in the registry record, and no category counts are available to interpret.
One possible analysis could compare the distribution across all response categories, while another could compare a chosen grouping of categories. These answer different questions. For example, a grouped response rate depends on which categories are included, and a distributional comparison retains information about each category. The registry record does not specify a grouping or report an overall distributional test. It therefore does not support reconstruction of a primary response contrast.
Why does the assessment schedule matter?
The primary endpoint describes assessments from baseline to measured progressive disease. The schedule is every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years. Because measurements are repeated, the observed response classification may depend on the time point selected and the rules for confirmation or progression. General statistical methods for longitudinal or time-to-event outcomes can account for repeated measurements or event timing, but the registry record does not say whether any such methods were used for the primary endpoint.
Time to Progressive Disease and Progression-Free Survival are listed secondary outcomes. In general, time-to-event analyses use information on when an event occurs and on follow-up that ends before an event is observed. A valid interpretation depends on the event definition, censoring rules, follow-up, and model or estimator. Those details and numerical estimates are not reported in the registry record. The same applies to Overall Survival and Duration of Response: their names alone do not specify the analysis method or the result.
How should uncertainty be assessed?
A confidence interval is a general statistical tool for expressing the uncertainty around an estimate under a specified method and assumptions. An interval around a response rate or a between-group contrast would help readers assess the range of values compatible with the observed data. No confidence interval or primary effect estimate is reported in the registry record. A p-value, if available, would address a different question and would not replace an estimate of the size and precision of the difference; no primary p-value is reported either.
For outcomes expressed as participant counts, a general analysis might use a model for binary events or a method for comparing proportions. The appropriate approach depends on the outcome definition, number of categories, denominators, and analysis population. In general, over-dispersion matters when observed variability exceeds what a chosen probability model expects; ignoring it can make uncertainty estimates too narrow. The registry record does not identify a count model or report evidence of over-dispersion, so this is a general consideration, not a trial-specific finding.
What do the planning assumptions mean?
The sample-size planning description states a two-sided significance level of 0.05, equal allocation between groups, and a normal approximation. It says that the effect to detect is a stated fraction of the observed effect. For time-to-event planning, it describes total events using the Schoenfeld approach; other planning quantities are participants per arm. These are planning assumptions, not a report of the trial's own design justification or of observed statistical power. The registry record does not report a protocol-based sample-size justification, the target effect, or a calculation for this trial. No planning value should be interpreted as an observed result.
General planning calculations ask what sample size might be needed under specified assumptions. They do not show whether a trial actually achieved a particular level of power after enrollment, nor do they establish that an observed effect is real. In this record, the planning description refers to fractions of an observed effect, but the response result needed to identify that effect is not reported. The record also does not state whether the planning framework was used prospectively in this trial.
Finally, the registry record's absence of reported analyses prevents assessment of model assumptions, estimation choices, or sensitivity analyses. Randomization supports a treatment-group comparison in principle, but it does not substitute for a reported analysis with defined outcomes, denominators, and uncertainty. The trial's statistical findings cannot be reconstructed from the design and endpoint definitions alone.
10. Multiplicity, Missing Data and Analysis Populations
The record lists a primary tumor-response endpoint and four secondary outcomes: Time to Progressive Disease, Progression-Free Survival, Overall Survival, and Duration of Response. It also lists 11 outcome measures, but 0 analyses. The registry record does not report how many hypotheses were formally tested, whether outcomes were ranked, or whether any multiplicity adjustment was planned or used.
As a general statistical point, testing multiple outcomes or multiple response categories can increase the chance that at least one apparently notable result occurs by chance. A prespecified testing strategy can clarify which comparisons are confirmatory and how uncertainty is interpreted across outcomes. No such strategy is reported in the registry record. The primary response outcome itself has several categories or time points and is not reduced to one comparison in the registry information. That makes the target estimand—the specific contrast intended to answer the primary question—unclear from the record.
The primary population is named as the Intent-to-Treat Population. The registry record does not report the number analyzed in that population, how participants were classified after randomization, or how the primary endpoint handled missing assessments. It does not report the amount or pattern of missing data, reasons for missingness, imputation, or sensitivity analyses. These omissions limit assessment of whether the reported population and outcome measurements represent all randomized participants.
For the secondary time-to-event outcomes, censoring rules and follow-up completeness are not reported. General statistical interpretation of such outcomes depends on those details, as well as on a defined analysis population and event definition. Without these methods and results, the record does not support an assessment of multiplicity, missing-data sensitivity, or the impact of departures from the stated population.
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 |
|---|---|---|---|
| A+FFG | 11 | 42 | 26.2% |
| A + FOLFOX 4 | 8 | 42 | 19.0% |
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 |
|---|---|
| A+FFG | 40 of 42 |
| A + FOLFOX 4 | 41 of 42 |
Most frequent serious adverse event terms
| Event term | Organ system | A+FFG | A + FOLFOX 4 |
|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | 1 of 42 | 2 of 42 |
| Neutropenia | Blood and lymphatic system disorders | 0 of 42 | 2 of 42 |
| Myocardial infarction | Cardiac disorders | 0 of 42 | 2 of 42 |
| Diarrhoea | Gastrointestinal disorders | 1 of 42 | 1 of 42 |
| Perirectal abscess | Gastrointestinal disorders | 1 of 42 | 1 of 42 |
| Urinary tract infection | Infections and infestations | 0 of 42 | 2 of 42 |
| Palpitations | Cardiac disorders | 1 of 42 | 0 of 42 |
| Constipation | Gastrointestinal disorders | 0 of 42 | 1 of 42 |
| Enteritis | Gastrointestinal disorders | 1 of 42 | 0 of 42 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | 0 of 42 | 1 of 42 |
Most frequent non-serious adverse event terms
| Event term | Organ system | A+FFG | A + FOLFOX 4 |
|---|---|---|---|
| Fatigue | General disorders | 22 of 42 | 24 of 42 |
| Nausea | Gastrointestinal disorders | 19 of 42 | 25 of 42 |
| Neutropenia | Blood and lymphatic system disorders | 24 of 42 | 16 of 42 |
| Diarrhoea | Gastrointestinal disorders | 15 of 42 | 17 of 42 |
| Constipation | Gastrointestinal disorders | 15 of 42 | 10 of 42 |
| Vomiting | Gastrointestinal disorders | 8 of 42 | 15 of 42 |
| Thrombocytopenia | Blood and lymphatic system disorders | 14 of 42 | 8 of 42 |
| Anaemia | Blood and lymphatic system disorders | 16 of 42 | 4 of 42 |
| Pyrexia | General disorders | 10 of 42 | 6 of 42 |
| Anorexia | Metabolism and nutrition disorders | 8 of 42 | 8 of 42 |
Serious events with the highest arm-level rate: neutropenia (4.8%), myocardial infarction (4.8%), small intestinal obstruction (4.8%), urinary tract infection (4.8%), palpitations (2.4%).
The adverse-event record lists 42 participants at risk in each group. Serious adverse events are recorded for 11 participants in A+FFG and 8 participants in A + FOLFOX 4. Other adverse events are recorded for 40 participants in A+FFG and 41 participants in A + FOLFOX 4. These are participant counts, not event rates calculated for comparison. The registry record does not report a statistical test or uncertainty interval for the group differences.
The listed serious event terms include Neutropenia, Myocardial infarction, Small intestinal obstruction, and Urinary tract infection, each at 4.8%; Palpitations and Constipation are each listed at 2.4%. The record does not assign these listed percentages to a particular treatment group, so they should not be interpreted as arm-specific comparisons. Death counts are not reported in the registry record.
As a general point, adverse-event counts depend on the definitions, observation period, and completeness of reporting. The registry record does not explain those details or provide event-level information. The counts describe what is posted, but they do not establish comparative safety, causality, or the overall balance of harms.
12. What the Result Does, and Does Not, Mean
The record establishes that a randomized phase II trial was designed to compare two Avastin-containing regimens in metastatic colorectal cancer, with RECIST tumor response as the primary outcome. It also identifies secondary outcomes related to progression, survival, duration of response, and adverse events. These details define the subject of the comparison, but they do not provide the primary outcome results.
No category-specific response counts, effect estimate, confidence interval, or primary statistical test are reported in the registry record. As a result, it is not possible to determine from this record whether response differed between the groups, the direction of any difference, or how precise an estimate might be. This absence is not evidence that the groups were the same; it means that the reported information does not quantify their comparison.
The serious and other adverse-event counts provide limited descriptive safety information. They do not, on their own, show whether one regimen caused more harm, and the listed serious-event percentages are not linked to a particular arm in the record. The listed secondary outcomes also have no results reported in the registry record, so they cannot support conclusions about progression or survival.
As a general statistical distinction, a trial's design and its findings are separate. Randomization describes how treatment groups are intended to be formed; an outcome analysis is needed to estimate differences and their uncertainty. Even a reported estimate would need to be interpreted in light of endpoint definitions, missing data, follow-up, and analysis methods. Those considerations are not resolved by the record's design information.
The record therefore supports a careful account of what was planned and how the primary endpoint was defined, along with the adverse-event counts that are listed. It does not support a claim that either regimen was better or worse on tumor response, progression, survival, or overall safety.
13. Why This Trial Matters Statistically
This trial is statistically notable as a randomized comparison of two multi-drug regimens in metastatic colorectal cancer, with common components and a different additional drug in each arm. That structure makes the intended contrast explicit: the study compares the full regimens, rather than isolating the effect of Avastin, 5FU/folinic acid, gemcitabine, or oxaliplatin individually. Any difference in a trial outcome would therefore be attributable to the assigned regimen contrast as a whole, subject to the study design and analysis.
The primary endpoint uses RECIST categories rather than one continuous tumor measurement. This highlights the importance of defining how categories are summarized and how repeated assessments are treated. The registry record gives category definitions and a detailed assessment schedule, yet does not state a single primary comparison or report the category counts. That gap illustrates why an endpoint label alone is not enough to reproduce or interpret an analysis.
The trial also lists progression and survival outcomes alongside response and safety measures. Those outcomes represent distinct questions: tumor response classification is not interchangeable with time to progression, progression-free survival, overall survival, or duration of response. A statistically careful report would identify each outcome's definition, analysis population, and uncertainty. Those details and results are not reported in the registry record.
Finally, the record shows why enrollment, randomization, and endpoint definitions should not be mistaken for evidence of treatment effect. The trial enrolled 84 participants, but the posted information does not give the primary response comparison. The design can clarify the intended question, while the absence of reported results leaves its statistical answer unresolved.
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.
A major limitation for interpretation is that the registry record does not report a single primary response comparison or category-specific outcome counts. The primary endpoint has multiple response categories and scheduled assessments, but the record does not specify how those were reduced to an analysis or how a response summary was calculated. No effect estimate, confidence interval, or primary test is reported.
The record states that the primary population is the Intent-to-Treat Population, but gives no number analyzed and no account of participants with missing or unevaluable response assessments. It also does not report follow-up completeness, reasons for missing data, or sensitivity analyses. These omissions prevent assessment of the impact of missing information on the endpoint.
Although randomization and no masking are reported, details of sequence generation, allocation concealment, and actual allocation are not reported in the registry record. Nor are treatment doses, adherence, discontinuations, or response-assessment procedures. The registry record does not report the sample-size justification, a prespecified statistical plan, or the method used to analyze the secondary outcomes.
Safety reporting is also limited: adverse-event counts are available, but the observation period and event definitions are not described. The listed serious-event percentages are not linked to a treatment group, and deaths are not reported in the registry record. These limitations mean that the available safety counts should be read descriptively rather than as a complete comparative assessment.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer — NCT00192075.
- Registry record last updated 2011-02-07; status last verified 2009-11.
- Results first posted 2009-12-23.
- 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
The registry record describes a completed, multicenter, randomized phase II parallel-group trial with no masking and enrollment of 84 participants. It compares Avastin plus gemcitabine plus 5FU/folinic acid with Avastin plus oxaliplatin plus 5FU/folinic acid. Eli Lilly and Company is listed as sponsor, and the start is recorded as 2003-06.
The primary endpoint is RECIST tumor response in the Intent-to-Treat Population. The record defines four response categories and an assessment schedule, but does not report one primary comparison or numerical response results. Time to Progressive Disease, Progression-Free Survival, Overall Survival, and Duration of Response are listed as secondary outcomes without reported results.
Adverse-event counts are listed for 42 participants at risk in each group. Serious-event counts are 11 in A+FFG and 8 in A + FOLFOX 4; other-event counts are 40 and 41, respectively. The registry record does not report analyses, effect estimates, or uncertainty for the treatment comparison.