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 Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer (NCT00399035), a randomized phase 3 study. The primary outcome is Progression-free Survival.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00399035 |
| Phase | Phase 3 |
| Condition | Metastatic Colorectal Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Quadruple |
| Enrollment | 1254 |
| Arms in the primary outcome | 2 |
| Lead sponsor | AstraZeneca |
| Results posted | Yes |
2. Clinical Question
Population
People with previously untreated metastatic colorectal cancer. The registry describes the condition as metastatic colorectal cancer and records an enrollment of 1254. Efficacy results for the selected cediranib dose compare participants in the cediranib 20 mg and placebo groups.
Intervention
Cediranib, with the 20 mg dose selected to continue, added to chemotherapy. The chemotherapy was either FOLFOX (5-fluorouracil, leucovorin and oxaliplatin) or XELOX (capecitabine and oxaliplatin). The study initially included cediranib 20 mg and 30 mg doses.
Comparator
Placebo added to FOLFOX or XELOX. The registry lists separate chemotherapy combinations in both cediranib and placebo arms, so the comparison concerns adding cediranib rather than comparing the chemotherapy regimens with one another.
Primary question
The primary endpoint was progression-free survival, measured in months. The study asked whether adding cediranib to chemotherapy was associated with a different time to disease progression under RECIST assessment. The registry also lists overall response rate, change in tumour size, resection of liver metastases, and other secondary outcomes.
The registry describes this as a randomized, double-blind, phase III study with a parallel design and quadruple masking. The stated purpose was to determine whether cediranib added to chemotherapy was more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression. The posted primary endpoint is progression-free survival, while the posted efficacy analyses compare the selected 20 mg dose with placebo. The record does not give a sponsor-reported hazard ratio or other inferential comparison for that primary endpoint, so the posted median values should be read as descriptive results rather than a complete estimate of the treatment contrast.
3. Trial Design
This was a randomized, double-blind, phase III, parallel-group study with quadruple masking. The registry lists an enrollment of 1254 and identifies AstraZeneca as the sponsor. The study status is completed. The record lists a start of 2006-11 and primary completion of 2010-03.
The study compared cediranib added to chemotherapy with placebo added to chemotherapy in people with previously untreated metastatic colorectal cancer. The chemotherapy options were FOLFOX, consisting of 5-fluorouracil, leucovorin and oxaliplatin, or XELOX, consisting of capecitabine and oxaliplatin. The four listed arms combine each chemotherapy option with either cediranib or placebo. The registry says that cediranib 20 mg and 30 mg were initially included, with the intention that one dose would be selected for continuation. The decision was to continue with 20 mg, and all efficacy analyses compared cediranib 20 mg with placebo.
The primary endpoint was median progression-free survival in months. The efficacy results list 502 participants in the cediranib 20 mg group and 358 in the placebo group for this endpoint. The safety record separately includes a cediranib 30mg group, as well as cediranib 20mg and placebo groups. These figures should not be treated as interchangeable: the primary efficacy comparison is specified as 20 mg versus placebo, while the safety listing includes the initially studied higher dose.
The registry does not report the randomization method, allocation concealment procedures, the allocation ratio, or the planned sample-size justification. It also does not report how participants were assigned between FOLFOX and XELOX or whether analyses were stratified by chemotherapy regimen. Those design details are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Cediranib 30 mg discontinued following Phase II, Cediranib 20 mg chosen dose for comparing with Placebo. 1254 patients enrolled to the study, 1076 recieved study treatment; 2 patients lost for Cediranib 20 mg/day, and 2 patients lost for Cediranib 30 mg/day.The 4 patients that didn't receive drug are intentionally included.
Overall Study
| Stage | Cediranib 20 mg/Day | Cediranib 30 mg/Day | Placebo |
|---|---|---|---|
| STARTED | 502 | 216 | 358 |
| COMPLETED | 189 | 58 | 106 |
| NOT COMPLETED | 313 | 158 | 252 |
Reasons for not completing this period:
| Reason | Cediranib 20 mg/Day | Cediranib 30 mg/Day | Placebo |
|---|---|---|---|
| Death | 289 | 141 | 234 |
| Lost to Follow-up | 2 | 1 | 5 |
| Withdrawal by Subject | 19 | 15 | 12 |
| Incorrect enrolment/eligib not fulfilled | 1 | 0 | 1 |
| Severe non-compliance with protocol | 2 | 1 | 0 |
Analysis population for the primary outcome, as defined in the registry: Two cediranib doses (20 mg and 30 mg) were initially included in this study; however, it was intended that one dose would be selected for continuation.The decision was taken to continue with cediranib 20 mg. All efficacy analyses compared cediranib 20mg to placebo. No statistical analyses were performed on the 30mg group.
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 | Cediranib 20 mg | Placebo | Cediranib 30 mg | Total |
|---|---|---|---|---|---|
| Participants analysed | 502 | 358 | 216 | 1076 | |
| Age, Continuous | years | 57.8 (SD 11.14) | 57.2 (SD 11.63) | 59.4 (SD 10.69) | 57.6 (SD 11.34) |
| Gender: Female | Participants | 203 | 146 | 93 | 442 |
| Gender: Male | Participants | 299 | 212 | 123 | 634 |
6. Primary Endpoint
The registry lists the primary outcome as Progression-free Survival, measured over RECIST assessed at baseline every 6 weeks through to week 24 and 12 week thereafter through to progression or data cut off date of 21/03/10 whichever was earliest..
| Element | Registry entry |
|---|---|
| Result type | Median |
| Measure of spread | Inter-Quartile Range |
| Unit | Months |
| Endpoint classification | Time-to-Event Analysis |
Progression-free survival measures the time until disease progression or another event defined by the study endpoint. The registry reports the endpoint as a median time in months and describes tumour assessment using RECIST criteria. Under those criteria, target lesions can be classified as complete response, partial response, progressive disease or stable disease according to changes in lesion measurements. The description also includes categories for non-target lesions.
The registry states that assessments were made at baseline, every 6 weeks through week 24, and every 12 weeks thereafter through progression or the data cut-off date of 21/03/10, whichever was earliest. This assessment schedule is relevant because progression-free survival depends on when progression is detected, not only on when biological change begins. The interval between assessments can therefore affect the observed timing of an event.
A median gives the time by which half of the observed group has experienced the event, under the endpoint's analysis definition. It is not an average, and it does not describe every participant's course. An interquartile range conveys the spread of the middle portion of the observed times. These summaries describe each group, but they do not by themselves quantify the uncertainty in the difference between groups or account for the time-to-event comparison that would ordinarily use censoring information.
Progression-free survival is used to summarize how long participants remain alive without documented progression. The registry does not report an endpoint-specific hazard ratio, confidence interval for a between-group effect, or inferential test for this primary outcome. The available medians and interquartile limits therefore do not establish the magnitude or precision of a treatment contrast.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary endpoint results are median progression-free survival of 8.6 months for cediranib 20 mg and 8.2 months for placebo. The corresponding reported interquartile limits are 5.5 to 12.1 months and 4.1 to 11.1 months. These are descriptive summaries for the two groups. The ranges of observed times overlap, but overlapping interquartile limits are not a formal test and cannot establish whether a between-group effect is compatible with chance or how precisely it is estimated.
The record does not provide a sponsor-reported hazard ratio, confidence interval, or p-value for progression-free survival. It also records no analyses in its analysis listing and indicates that values are missing or not estimable for a two-arm comparison of the median time endpoint. As a result, the median summaries do not supply the information needed to make an inferential claim about the primary comparison. The registry record does not report the analysis population or the handling of censoring and missing endpoint assessments.
The secondary outcomes include binary measures and a continuous measure. Their posted comparisons are unadjusted calculations rather than sponsor-reported analyses; the registry lists no reported analyses for these outcomes. For overall response rate, the risk difference is 0.009, with a 95% confidence interval from -0.059 to 0.077 and an unadjusted p-value of 0.8. For best percentage change in tumour size, the mean difference is -1.88, with a 95% confidence interval from -6.124 to 2.364 and an unadjusted p-value of 0.385. For resection of liver metastases, the risk difference is -0.009, with a 95% confidence interval from -0.045 to 0.028 and an unadjusted p-value of 0.647. Each interval includes the value of no difference for its stated measure. These recalculations are simple unadjusted comparisons from the posted summaries and are not a substitute for an analysis specified and reported by the sponsor.
Confidence intervals describe a range of effect estimates compatible with the data under the calculation's assumptions; they do not guarantee that the true effect lies within the interval. The binary-outcome intervals span effects in both directions. The mean-change interval likewise includes values on either side of no difference. The results therefore do not establish a clear direction or precise size of effect for these secondary comparisons. Because multiple outcomes are listed and no adjustment for multiplicity is reported, isolated unadjusted p-values should not be treated as definitive evidence.
The record's primary and secondary results are not a complete account of the trial's statistical evidence. In particular, the central time-to-event outcome lacks the sponsor's effect estimate and uncertainty interval in the registry. The conclusions that can be drawn from the posted values are correspondingly limited to describing the group summaries and the unadjusted secondary comparisons.
9. Statistical Methods Explained
The primary endpoint is a time-to-event outcome. For this type of outcome, participants can have different lengths of follow-up, and some may not have a recorded progression by the last observation available. A standard analysis accounts for those incomplete event times through censoring rather than treating each participant's follow-up as if it were complete. The registry gives the assessment schedule and a data cut-off date, but does not report the censoring rules, the analysis population, or a sponsor-reported time-to-event model. A hazard ratio and its confidence interval are not reported in the registry record.
What a median can and cannot tell us
The median progression-free survival is a point on the time scale: it marks the estimated time by which half of the group has experienced the endpoint. It is useful as a group summary, but it does not represent the full shape of the time-to-event experience. Two groups can have similar medians yet differ in other parts of their event-time distributions, or have different medians while uncertainty around the estimates remains substantial. An interquartile range describes the central spread of observed or estimated times, but it is not a confidence interval for the median and is not an interval for the treatment effect.
Here, the registry reports medians and interquartile limits for cediranib 20 mg and placebo, but does not report the inferential comparison for the primary outcome. A comparison of the two medians alone would leave out the event-time information and censoring that a time-to-event analysis uses. No new treatment-effect estimate should be reconstructed from those group summaries.
How to read the secondary comparisons
The registry's secondary comparisons use different effect measures for different outcome types. A risk difference expresses the contrast in event proportions between groups on an absolute scale. A mean difference expresses the contrast between group averages for a continuous outcome. These measures answer different questions and their numerical magnitudes should not be compared directly across outcomes.
The confidence intervals around these estimates communicate uncertainty. A wider interval indicates less precision than a narrower interval, though the interpretation also depends on the outcome scale and the study question. An interval that includes no difference is compatible with a range of estimates that includes no contrast under the stated calculation. It does not prove equality, and it does not rule out all potentially relevant effects. The intervals and p-values listed for the secondary outcomes are unadjusted recalculations from posted summary statistics. They are not reported sponsor analyses.
The unadjusted p-value measures how unusual results at least as inconsistent with a no-difference model would be under that model and the calculation's assumptions. It does not measure the probability that the no-difference model is true, nor does it describe the size or importance of an effect. The registry does not report a prespecified analysis plan for these outcomes, so the role of these recalculated tests in the trial's original inferential plan is not established.
Why multiplicity matters
Testing several outcomes creates multiple opportunities for an apparently notable result to arise by chance. A multiplicity procedure can account for that issue, for example by controlling the overall error rate across a defined family of tests. The record lists multiple secondary outcomes but does not report whether they were organized into a testing hierarchy or whether any adjustment was planned or used. Therefore, the posted unadjusted p-values should be interpreted cautiously and should not be treated as if they account for all outcome testing.
Planning illustrations are not observed power
The planning illustrations are based on the observed effects and assume a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. They show hypothetical participant requirements for detecting stated fractions of the observed effect under those assumptions. They are not the trial's original sample-size calculation, and they do not describe the trial's observed power. Sample-size planning based on an observed effect can be especially unstable when that effect is imprecisely estimated. The registry does not report the study's own sample-size justification or assumptions.
For time-to-event outcomes, planning can depend on the number of events rather than only the number of participants. The registry's general planning note distinguishes total events for time-to-event illustrations from participants per arm for other illustrations. However, the primary endpoint's registry analysis does not include the sponsor's effect estimate needed to interpret a treatment-effect calculation, and no primary planning illustration is reported in the posted results.
Analysis populations and missingness
Randomization helps define a comparison, but interpretation also depends on which participants are included in each analysis and how missing measurements are handled. Common analysis populations can include all randomized participants or subsets defined by treatment received, protocol adherence, or availability of outcome measurements. Those choices can affect what question an estimate answers. The registry does not report the population used for the primary analysis, whether all randomized participants were analyzed in their assigned group, or how missing outcome data were addressed. The registry also does not report sensitivity analyses for missingness or censoring. These omissions limit assessment of the robustness of the posted summaries.
10. Multiplicity, Missing Data and Analysis Populations
The record lists multiple secondary outcomes, including overall response rate, best percentage change in tumour size, duration of response, rate of resection of liver metastases, and time to wound healing complications. It does not report how many hypotheses were planned, whether outcomes were grouped into families, whether a hierarchical testing strategy was used, or whether p-values were adjusted for multiple comparisons. A multiplicity adjustment is not reported in the registry record.
This matters because the interpretation of an individual unadjusted p-value changes when several outcomes are examined. Without knowing the planned analysis family and testing procedure, it is not possible to determine whether any nominal result was intended to be confirmatory. The posted unadjusted comparisons should therefore be viewed as limited evidence rather than as a controlled set of confirmatory tests.
The registry does not report the primary analysis population, the secondary analysis populations, or whether participants were analyzed according to randomized assignment. The record also does not describe how missing measurements were handled, how participants without a recorded event were censored, or whether sensitivity analyses assessed alternative assumptions. These details are important for judging whether the results could be affected by incomplete follow-up or outcome availability.
The primary endpoint is described as assessed at scheduled intervals, but the record does not state how assessments outside the schedule were handled or how the endpoint date was determined when progression occurred between assessments. It also does not provide a detailed statistical analysis plan or sponsor-reported inferential analysis for the primary endpoint. These items are not reported in the registry record, so the posted group summaries cannot be independently placed in the context of a complete prespecified 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 |
|---|---|---|---|
| Cediranib 30mg | 94 | 214 | 43.9% |
| Cediranib 20mg | 204 | 500 | 40.8% |
| Placebo | 105 | 358 | 29.3% |
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 |
|---|---|
| Cediranib 30mg | 209 of 214 |
| Cediranib 20mg | 485 of 500 |
| Placebo | 341 of 358 |
Most frequent serious adverse event terms
| Event term | Organ system | Cediranib 30mg | Cediranib 20mg | Placebo |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 14 of 214 | 34 of 500 | 11 of 358 |
| Dehydration | Metabolism and nutrition disorders | 8 of 214 | 14 of 500 | 7 of 358 |
| Vomiting | Gastrointestinal disorders | 5 of 214 | 7 of 500 | 8 of 358 |
| Thrombocytopenia | Blood and lymphatic system disorders | 0 of 214 | 11 of 500 | 7 of 358 |
| Pneumonia | Infections and infestations | 3 of 214 | 7 of 500 | 8 of 358 |
| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | 4 of 214 | 10 of 500 | 4 of 358 |
| Hypertension | Vascular disorders | 8 of 214 | 6 of 500 | 2 of 358 |
| Intestinal Obstruction | Gastrointestinal disorders | 3 of 214 | 8 of 500 | 4 of 358 |
| Febrile Neutropenia | Blood and lymphatic system disorders | 4 of 214 | 4 of 500 | 3 of 358 |
| Pyrexia | General disorders | 2 of 214 | 5 of 500 | 4 of 358 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Cediranib 30mg | Cediranib 20mg | Placebo |
|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 147 of 214 | 346 of 500 | 165 of 358 |
| Nausea | Gastrointestinal disorders | 92 of 214 | 256 of 500 | 169 of 358 |
| Decreased Appetite | Metabolism and nutrition disorders | 92 of 214 | 229 of 500 | 125 of 358 |
| Vomiting | Gastrointestinal disorders | 83 of 214 | 230 of 500 | 126 of 358 |
| Fatigue | General disorders | 80 of 214 | 200 of 500 | 104 of 358 |
| Hypertension | Vascular disorders | 96 of 214 | 226 of 500 | 41 of 358 |
| Thrombocytopenia | Blood and lymphatic system disorders | 56 of 214 | 139 of 500 | 84 of 358 |
| Peripheral Sensory Neuropathy | Nervous system disorders | 45 of 214 | 141 of 500 | 89 of 358 |
| Neutropenia | Blood and lymphatic system disorders | 49 of 214 | 138 of 500 | 75 of 358 |
| Abdominal Pain | Gastrointestinal disorders | 32 of 214 | 134 of 500 | 78 of 358 |
Serious events with the highest arm-level rate: diarrhoea (6.8%), dehydration (3.7%), hypertension (3.7%), vomiting (2.3%), renal failure (2.3%).
The registry reports serious adverse event counts for three groups: cediranib 30mg, cediranib 20mg and placebo. The corresponding numbers at risk are 214, 500 and 358, and the numbers with a serious adverse event are 94, 204 and 105. It also reports other adverse event counts, but these are a separate category from serious adverse events. The listing does not provide death counts.
The most frequently listed serious adverse event terms are Diarrhoea at 6.8%, Dehydration at 3.7%, Hypertension at 3.7%, Vomiting at 2.3%, Renal Failure at 2.3%, and Pneumonia at 2.2%. These percentages describe the registry's listed terms; they should not be interpreted as a complete account of all possible adverse events or as a comparison adjusted for exposure or other factors.
Comparisons across safety groups require caution. The cediranib 30mg group was part of the initially included dose groups, while the stated efficacy analyses compared cediranib 20 mg with placebo. The registry does not report the safety analysis methods, exposure duration, event-level definitions beyond the listed categories, or a statistical comparison of adverse event rates. The counts describe what is posted, but do not alone establish a causal difference between groups.
12. What the Result Does, and Does Not, Mean
The registry shows group-level summaries for progression-free survival and several secondary outcomes in a randomized trial of cediranib added to FOLFOX or XELOX versus placebo added to those chemotherapy options. The primary endpoint medians are available for the selected cediranib 20 mg dose and placebo. However, the registry does not report a sponsor-reported hazard ratio, confidence interval, or p-value for the primary comparison. The medians therefore provide a descriptive account, not a complete estimate of the comparative treatment effect.
The secondary comparisons add information about response, tumour-size change and resection of liver metastases. Their confidence intervals and unadjusted p-values are recalculated from posted summary statistics, rather than reported sponsor analyses. They are not adjusted for multiple testing, and the registry does not report a multiplicity plan. The results should not be used to make a definitive claim about benefit, lack of benefit, or equivalence.
Nor do the posted summaries establish why any observed differences arose. The record does not report enough detail about analysis populations, missing data, censoring, stratification, or the statistical analysis plan to evaluate those issues. The safety figures describe adverse events in the listed groups but do not provide a controlled causal comparison or complete exposure context.
In general, a confidence interval communicates uncertainty around an estimate, and a point estimate without an interval can give an incomplete impression of precision. Here, the missing primary effect estimate is particularly important because the primary question concerns time to progression. The reported endpoint summaries can be described, but the registry information does not support a definitive inference about the magnitude or precision of the primary between-group effect.
13. Why This Trial Matters Statistically
This trial is statistically notable because the registry distinguishes a descriptive primary endpoint summary from a complete inferential comparison. Median progression-free survival is posted for cediranib 20 mg and placebo, but no sponsor-reported hazard ratio, confidence interval or p-value accompanies those medians. For a time-to-event question, the median alone does not capture the full event-time pattern or the effect of censoring. Readers should not treat a pair of group medians as if they were a formal treatment-effect estimate.
The record also illustrates why outcome-specific denominators and analysis populations matter. Different secondary outcomes have different numbers of participants with results, and the analysis population is not reported. Without a clear account of who was included and how missing measurements were addressed, it is difficult to assess how representative each posted summary is of the randomized groups.
Another important statistical issue is multiplicity. Several secondary outcomes are listed, while the posted tests are unadjusted recalculations and no testing hierarchy is reported. A nominal result among multiple comparisons has a different evidential status from a prespecified primary analysis. The secondary results can provide context, but they do not repair the missing primary inferential result.
Finally, planning illustrations based on observed effects should not be mistaken for evidence that the trial was adequately or inadequately powered. They are hypothetical planning calculations under stated assumptions, not observed power and not the registry's original design justification. The record does not report the original sample-size assumptions. These distinctions help keep descriptive estimates, inferential evidence and planning exercises separate.
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 has several trial-specific reporting limitations. The primary outcome is summarized by group medians and interquartile limits, but the sponsor-reported hazard ratio and its confidence interval are not reported. The record also does not provide an inferential test for the primary comparison. This prevents a direct assessment of the estimated relative effect and its precision from the registry results.
The primary endpoint description gives an assessment schedule and RECIST criteria, but important operational details are absent. The record does not report the censoring rules, how progression dates were assigned between scheduled assessments, or how deaths and other events were incorporated into the endpoint definition. It does not provide the primary analysis population or missing-data procedures.
The study included two cediranib doses initially, but efficacy analyses were restricted to the selected 20 mg dose versus placebo. The registry does not report further details about the decision process or whether it was made before outcome data were examined. No assumptions should be made about that process from the brief description alone. The record also does not state how FOLFOX and XELOX use was distributed or whether the efficacy comparison accounted for chemotherapy regimen.
For secondary outcomes, numerical comparisons are available for some listed measures but not all. The registry lists no sponsor-reported analyses for these outcomes, and it does not report an adjustment for multiple testing. Analysis denominators differ across outcomes, while the analysis populations and missing-data handling are not specified. These factors limit comparability and make the secondary results less conclusive.
Safety reporting includes adverse-event counts and selected serious event terms, but the registry does not give exposure-adjusted rates, detailed follow-up duration by group, or statistical comparisons. Death counts are not posted. These omissions constrain interpretation of the safety summaries and do not allow a complete benefit-risk assessment from this record alone.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer — NCT00399035.
- Registry record last updated 2016-12-28; status last verified 2016-10.
- Results first posted 2012-10-30.
- 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 describes a completed, randomized, double-blind, phase III, parallel study with quadruple masking in previously untreated metastatic colorectal cancer. It lists an enrollment of 1254 and compares cediranib added to FOLFOX or XELOX with placebo added to those chemotherapy regimens. Cediranib 20 mg was selected for continued efficacy analyses after the study initially included 20 mg and 30 mg doses.
The primary endpoint was median progression-free survival assessed using RECIST. The record posts group medians and interquartile limits for cediranib 20 mg and placebo but does not report the primary treatment-effect estimate or its inferential uncertainty. Several secondary outcome summaries are posted, with unadjusted recalculations for selected comparisons. The record does not report a multiplicity plan, analysis populations, or missing-data procedures.
Serious adverse event counts are listed for the cediranib 30mg, cediranib 20mg and placebo groups, along with selected event terms. The record supports descriptive reading of these posted values, but important details needed for a full statistical interpretation are not reported in the registry record.