This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma (NCT02289898), a randomized phase 2 study. The primary outcome is Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02289898 |
| Phase | Phase 2 |
| Condition | Pancreatic Cancer |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 207 |
| Arms in the primary outcome | n/a |
| Lead sponsor | OncoMed Pharmaceuticals, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
Participants with first-line metastatic pancreatic ductal adenocarcinoma. The primary endpoint population is described as the intention-to-treat population in the placebo/placebo arm and pooled demcizumab arms.
Intervention
Gemcitabine and Abraxane® with demcizumab, given in either a truncated course or two truncated courses. The registry describes distinct schedules for these regimens.
Comparator
Gemcitabine and Abraxane® with placebo. The primary endpoint description compares the placebo/placebo arm with the pooled demcizumab arms.
Primary question
How did investigator-assessed progression-free survival compare between the placebo/placebo arm and the pooled demcizumab arms during the study? Numerical estimates for this comparison are not reported in the registry record.
The trial was designed to examine efficacy and safety when demcizumab was added to gemcitabine and Abraxane®. The registry describes a randomized, double-blind, three-arm study with equal allocation, while its masking field records triple masking. Those descriptions are both part of the registry record; further details about who was masked are not reported in the registry record.
The comparison combines the demcizumab regimens for the primary endpoint rather than presenting the primary question as separate comparisons of each regimen with placebo. The registry record does not report numerical progression-free survival estimates, a hazard ratio, a confidence interval, or a significance test. It therefore does not allow a reader to assess the direction or precision of the treatment contrast from the primary endpoint description alone.
3. Trial Design
This was a randomized, parallel-group phase 2 trial with three arms and an intended 1:1:1 allocation. The registry lists enrollment as 207 and the study status as completed. The listed condition is pancreatic cancer; the trial title and summary specify first-line metastatic pancreatic ductal adenocarcinoma. The sponsor was OncoMed Pharmaceuticals, Inc.
All arms included gemcitabine and Abraxane®. The placebo/placebo arm received placebo with the chemotherapy during the initial treatment period, chemotherapy without study drug during the next period, placebo with chemotherapy during a later period, and then chemotherapy until disease progression. One demcizumab arm used demcizumab during the initial period and placebo during the later study-drug period. The other used demcizumab during both of those periods. The descriptions identify these as truncated courses, but further administration details are not reported in the registry record.
The brief summary calls the study double blind, while the masking classification is triple. The registry record does not explain the difference or identify which roles were masked. Allocation concealment procedures, treatment adherence, protocol deviations, and the handling of treatment changes are not reported in the registry record.
The listed start date is 2015-04-20 and primary completion is recorded as 2017-05. The primary endpoint timeframe is investigator-assessed progression-free survival through the duration of the study, stated as 2 years, 23 days. These registry descriptions establish the broad design and follow-up period, but do not supply the detailed protocol or a complete account of study conduct.
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: A total of 207 subjects were randomized and 204 subjects were treated in the study.
Overall Study
| Stage | Placebo/Placebo Arm | Demcizumab/Placebo Arm | Demcizumab/Demcizumab Arm |
|---|---|---|---|
| STARTED | 68 | 71 | 65 |
| COMPLETED | 16 | 18 | 9 |
| NOT COMPLETED | 52 | 53 | 56 |
Reasons for not completing this period:
| Reason | Placebo/Placebo Arm | Demcizumab/Placebo Arm | Demcizumab/Demcizumab Arm |
|---|---|---|---|
| Death | 5 | 4 | 3 |
| Physician Decision | 2 | 5 | 2 |
| Withdrawal by Subject | 0 | 4 | 1 |
| Adverse Event | 3 | 5 | 5 |
| Disease progression | 34 | 28 | 34 |
| Use of another anticancer therapy | 0 | 0 | 1 |
| Other | 8 | 7 | 10 |
Analysis population for the primary outcome, as defined in the registry: Placebo/placebo arm and pooled demcizumab arms (ITT 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 | Placebo/Placebo Arm | Demcizumab/Placebo Arm | Demcizumab/Demcizumab Arm | Total |
|---|---|---|---|---|---|
| Participants analysed | 68 | 71 | 65 | 204 | |
| Age, Categorical: <=18 years | Participants | 0 | 0 | 0 | 0 |
| Age, Categorical: Between 18 and 65 years | Participants | 37 | 34 | 30 | 101 |
| Age, Categorical: >=65 years | Participants | 31 | 37 | 35 | 103 |
| Age, Continuous | years | 62 (41 to 82) | 63 (38 to 85) | 66 (30 to 78) | 63 (30 to 85) |
| Sex: Female, Male: Female | Participants | 27 | 31 | 30 | 88 |
| Sex: Female, Male: Male | Participants | 41 | 40 | 35 | 116 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 | 0 | 1 | 1 |
| Race (NIH/OMB): Asian | Participants | 1 | 0 | 1 | 2 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 | 1 | 0 | 1 |
| Race (NIH/OMB): Black or African American | Participants | 1 | 0 | 0 | 1 |
| Race (NIH/OMB): White | Participants | 60 | 70 | 62 | 192 |
| Race (NIH/OMB): More than one race | Participants | 0 | 0 | 0 | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 6 | 0 | 1 | 7 |
| Region of Enrollment: Canada | Participants | 3 | 5 | 4 | 12 |
| Region of Enrollment: Belgium | Participants | 2 | 2 | 2 | 6 |
| Region of Enrollment: United States | Participants | 17 | 18 | 15 | 50 |
| Region of Enrollment: United Kingdom | Participants | 3 | 2 | 4 | 9 |
| Region of Enrollment: Australia | Participants | 24 | 13 | 19 | 56 |
| Region of Enrollment: Spain | Participants | 19 | 31 | 21 | 71 |
6. Primary Endpoint
The registry lists the primary outcome as Hazard of Progression in the Placebo/Placebo Arm and the Pooled Demcizumab Arms, measured over Investigator-assessed progression-free survival time through duration of the study (2 years, 23 days)..
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary outcome is described as investigator-assessed progression-free survival, with Kaplan-Meier estimates for the placebo/placebo arm and pooled demcizumab arms. Progression-free survival concerns the time until disease progression or death, according to the endpoint definition used in the trial; the exact event and censoring rules are not reported in the registry record. The timeframe is through the study duration, listed as 2 years, 23 days.
In general, a time-to-event endpoint uses both whether an event occurred and how long participants remained under observation before an event or censoring. Kaplan-Meier estimation is a general method for describing the event-free probability over follow-up while accounting for participants whose event time is not observed during the study. A comparison of such estimates can convey more about timing than a simple count of events, provided the event definitions and follow-up rules are clear.
The registry’s outcome title refers to the hazard of progression, but the description specifies Kaplan-Meier estimates of progression-free survival. It also classifies the outcome as a participant count. This mix of time-to-event language and count metadata makes the endpoint presentation less clear. The numerical estimates, hazard ratio, uncertainty interval, and test result are not reported in the registry record, so the magnitude and precision of the comparison cannot be assessed from the endpoint description.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies a primary comparison of investigator-assessed progression-free survival between the placebo/placebo arm and the pooled demcizumab arms. It does not give the numerical Kaplan-Meier estimates or a numerical treatment contrast. Consequently, the direction of the observed comparison, its magnitude, and its precision are not reported in the registry record. No conclusion about the comparative efficacy of the regimens can be drawn from the endpoint description alone.
In general, a point estimate describes the observed contrast, while a confidence interval indicates the range of values compatible with the data under the analysis assumptions. A significance test addresses compatibility with a specified null hypothesis; it does not, by itself, establish clinical importance. None of the primary endpoint’s point estimate, confidence interval, or test result is reported in the registry record. The evidence therefore cannot be evaluated for either statistical precision or the size of a plausible effect.
The primary comparison pools the two demcizumab arms. That is the contrast specified in the endpoint description, not a reported result for either demcizumab schedule individually. The registry record does not provide the separate arm-level progression-free survival estimates needed to judge whether the schedules had similar or different observed outcomes. It also does not report how the pooled comparison was calculated beyond identifying the pooled groups and the intention-to-treat population.
The enrollment is recorded as 207, and the trial is described as randomized with equal intended allocation. Those design features do not substitute for outcome estimates. Group counts in the safety record refer to participants at risk for the listed safety summaries and should not be treated as outcome denominators for the primary endpoint. The actual analysis population size and the number of progression or death events are not reported in the registry record.
In general, time-to-event results depend on follow-up, event ascertainment, and censoring. Investigator assessment identifies who assessed progression, but the registry record does not describe assessment schedules, review procedures, censoring rules, or missing assessment handling. These omissions limit evaluation of how the endpoint was measured and analyzed. They do not establish that the trial lacked such procedures; those details are simply not reported in the registry record.
Any sample-size figures presented as planning illustrations should be interpreted as hypothetical design calculations based on stated assumptions, not as evidence that the trial had a particular probability of detecting an effect. They are not observed power. The registry record does not provide a sample-size justification or establish that the trial was designed around those illustrations. Overall, the record defines the broad comparison but lacks the numerical primary results and analytical detail required for a statistical assessment of that comparison.
9. Statistical Methods Explained
What does a randomized comparison contribute?
Random allocation is intended to make treatment groups comparable, on average, with respect to characteristics that could influence outcomes. In general, this supports interpretation of between-group differences as associated with assigned treatment, subject to the trial’s conduct, outcome measurement, and analysis. Randomization does not guarantee that groups are identical, and it does not remove uncertainty from a finite study. The registry describes randomization and equal intended allocation, but the sequence-generation and allocation-concealment methods are not reported in the registry record.
Why use a time-to-event endpoint?
In general, time-to-event methods retain information about when an event occurs and can use follow-up from participants who have not experienced the event by the end of observation. Kaplan-Meier estimates describe event-free experience over time. Participants whose event status is not observed for the full period may be censored, meaning their observed follow-up contributes up to a point without being treated as an event at that point. Valid interpretation depends on the censoring rules and assumptions. The registry names Kaplan-Meier estimates, but its censoring approach and related assumptions are not reported in the registry record.
The endpoint description uses progression-free survival, investigator assessment, and a hazard-of-progression title. In general, a hazard describes the instantaneous event rate among participants who remain event-free at a given time, whereas a Kaplan-Meier curve describes the estimated probability of remaining event-free over time. These are related but not identical summaries. The registry does not report a hazard ratio or explain how the hazard wording relates to the stated Kaplan-Meier estimates. It also does not define whether progression and death were both counted as events or give the assessment and adjudication rules.
What does pooling the demcizumab arms mean?
The primary endpoint description compares the placebo/placebo arm with pooled demcizumab arms. In general, pooling combines information from the intervention groups for a specified comparison, but it can obscure differences between regimens. Here, the two demcizumab schedules differ in whether demcizumab is used during the later study-drug period. The registry does not report separate primary endpoint estimates for the individual schedules or explain further how the pooled analysis was constructed. The pooled contrast should therefore not be read as a direct estimate for either schedule on its own.
How should uncertainty be assessed?
In general, a confidence interval communicates uncertainty around an estimated effect, including whether the data are compatible with effects in more than one direction or of different magnitudes. A p-value summarizes how unusual the data would be under a stated null model and analysis assumptions; it is not a measure of the probability that a treatment works. For a time-to-event comparison, interpretation is strongest when the estimate is presented with an uncertainty interval, event counts, follow-up information, and the analysis method. The registry record does not report the primary endpoint estimate, confidence interval, p-value, or event count.
The registry classifies the primary outcome as binary and describes its unit as participants, while also identifying progression-free survival and Kaplan-Meier estimates. In general, a participant count and a time-to-event estimate answer different statistical questions: a count records how many participants meet an event definition, while a time-to-event analysis incorporates timing and censoring. The metadata do not clarify the relationship between these representations. The record’s single listed outcome and analysis do not supply numerical results or enough methodological detail to resolve that ambiguity.
Why do analysis populations matter?
The endpoint population is identified as the intention-to-treat population. In general, an intention-to-treat analysis evaluates participants according to their randomized group, regardless of later treatment changes, when the analysis follows that principle. This preserves the randomized comparison, but the exact population rules, exclusions, and handling of missing outcome data still need to be specified. Those details are not reported in the registry record. The record does not state the analyzed participant counts or whether any participants were excluded from the primary analysis.
Planning calculations are also distinct from trial results. In general, a sample-size illustration applies assumptions about an effect, allocation, significance level, and statistical approximation to estimate a design requirement. It does not show that an effect was observed, nor does it establish observed power. Any planning figures associated with this trial should be read as illustrations, not as evidence about the primary endpoint. A trial-specific sample-size justification is not reported in the registry record.
10. Multiplicity, Missing Data and Analysis Populations
The registry identifies a primary endpoint and a comparison of the placebo/placebo arm with pooled demcizumab arms. It does not report a multiplicity strategy, such as how inference would be adjusted for multiple comparisons or outcomes. Although the study has three treatment arms, the primary endpoint description gives a pooled comparison rather than separate primary comparisons for each demcizumab schedule. Whether additional comparisons were planned, and how they would be interpreted, is not reported in the registry record.
The registry lists one outcome measure and one analysis, but those counts do not explain the complete testing strategy or establish that there were no other analyses. The protocol’s analysis plan, any interim analyses, stopping rules, and any prespecified subgroup analyses are not reported in the registry record. They should not be inferred from the trial’s phase or design description.
The endpoint population is named as intention-to-treat. The registry does not report the number analyzed, missing outcome data, loss to follow-up, censoring rules, or sensitivity analyses for missing or incomplete observations. In general, missingness and censoring can affect a time-to-event comparison if observation differs between groups or if assumptions about why follow-up ends are not appropriate. The registry record does not provide the detail needed to evaluate those possibilities.
These omissions are reporting limitations, not evidence that the trial had no prespecified procedures. Without the statistical analysis plan and numerical endpoint results, the handling of multiplicity and missing data cannot be independently assessed from 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 |
|---|---|---|---|
| Placebo/Placebo Arm | 40 | 68 | 58.8% |
| Demcizumab/Placebo Arm | 49 | 71 | 69.0% |
| Demcizumab/Demcizumab Arm | 34 | 65 | 52.3% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Placebo/Placebo Arm | 5 of 68 |
| Demcizumab/Placebo Arm | 12 of 71 |
| Demcizumab/Demcizumab Arm | 3 of 65 |
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 |
|---|---|
| Placebo/Placebo Arm | 68 of 68 |
| Demcizumab/Placebo Arm | 71 of 71 |
| Demcizumab/Demcizumab Arm | 65 of 65 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo/Placebo Arm | Demcizumab/Placebo Arm | Demcizumab/Demcizumab Arm |
|---|---|---|---|---|
| Pyrexia | General disorders | 6 of 68 | 3 of 71 | 6 of 65 |
| Vomiting | Gastrointestinal disorders | 5 of 68 | 4 of 71 | 5 of 65 |
| Sepsis | Infections and infestations | 3 of 68 | 4 of 71 | 4 of 65 |
| Diarrhoea | Gastrointestinal disorders | 1 of 68 | 4 of 71 | 3 of 65 |
| Abdominal pain | Gastrointestinal disorders | 4 of 68 | 0 of 71 | 3 of 65 |
| Nausea | Gastrointestinal disorders | 4 of 68 | 1 of 71 | 2 of 65 |
| Dehydration | Metabolism and nutrition disorders | 2 of 68 | 3 of 71 | 2 of 65 |
| Febrile neutropenia | Blood and lymphatic system disorders | 4 of 68 | 1 of 71 | 0 of 65 |
| Anaemia | Blood and lymphatic system disorders | 3 of 68 | 0 of 71 | 1 of 65 |
| Neutropenia | Blood and lymphatic system disorders | 1 of 68 | 1 of 71 | 2 of 65 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo/Placebo Arm | Demcizumab/Placebo Arm | Demcizumab/Demcizumab Arm |
|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | 42 of 68 | 38 of 71 | 41 of 65 |
| Diarrhoea | Gastrointestinal disorders | 34 of 68 | 41 of 71 | 45 of 65 |
| Anaemia | Blood and lymphatic system disorders | 27 of 68 | 43 of 71 | 35 of 65 |
| Fatigue | General disorders | 34 of 68 | 31 of 71 | 37 of 65 |
| Oedema peripheral | General disorders | 29 of 68 | 39 of 71 | 34 of 65 |
| Alopecia | Skin and subcutaneous tissue disorders | 30 of 68 | 33 of 71 | 28 of 65 |
| Vomiting | Gastrointestinal disorders | 27 of 68 | 32 of 71 | 25 of 65 |
| Pyrexia | General disorders | 24 of 68 | 30 of 71 | 23 of 65 |
| Decreased appetite | Metabolism and nutrition disorders | 19 of 68 | 30 of 71 | 27 of 65 |
| Neutropenia | Blood and lymphatic system disorders | 21 of 68 | 24 of 71 | 25 of 65 |
Serious events with the highest arm-level rate: pyrexia (9.2%), vomiting (7.7%), sepsis (6.2%), febrile neutropenia (5.9%), abdominal pain (5.9%).
The registry reports serious adverse event summaries by treatment group. In the placebo/placebo arm, 68 participants were at risk for the serious-event summary and 40 were recorded as affected. In the demcizumab/placebo arm, the corresponding counts were 71 and 49; in the demcizumab/demcizumab arm, they were 65 and 34. These are reported counts, not calculated percentages. The record also lists deaths as 5, 12, and 3 in those respective arms. The registry does not explain the relationship between these death counts and the serious adverse event summaries.
The listed serious-event terms and percentages are pyrexia, 9.2%; vomiting, 7.7%; sepsis, 6.2%; febrile neutropenia, 5.9%; abdominal pain, 5.9%; and nausea, 5.9%. The registry record does not specify the denominator or treatment-group attribution for these term percentages, so they should not be assigned to a particular arm based on this summary alone.
In general, serious adverse event counts describe safety events recorded under the trial’s definitions; they do not by themselves establish that a treatment caused an event. Interpretation also depends on event definitions, observation time, exposure, and reporting procedures. Those details are not reported in the registry record. The counts should be read as descriptive safety information rather than as a complete comparative safety analysis.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this was a randomized phase 2 study of gemcitabine and Abraxane® with placebo or demcizumab in first-line metastatic pancreatic ductal adenocarcinoma. It identifies investigator-assessed progression-free survival as the primary outcome and describes a comparison between the placebo/placebo arm and pooled demcizumab arms. It also provides selected serious adverse event counts and terms.
The record does not report numerical primary endpoint estimates, a hazard ratio, confidence interval, or significance test. It therefore does not show the size, direction, or precision of the progression-free survival comparison. The endpoint description alone cannot establish whether the observed outcomes differed, and it cannot support a conclusion about the comparative efficacy of the treatment regimens.
Likewise, the safety counts are descriptive. Without full definitions, exposure and follow-up information, and a complete comparative analysis, they do not establish whether an event was caused by a study treatment or whether safety differed between regimens. The listed term percentages lack a stated denominator and group attribution in the registry summary.
Any planning figures associated with the study are illustrations based on assumptions, not observed treatment effects or observed power. The registry record does not report the study’s sample-size justification. A planning calculation cannot replace the primary results or provide evidence about the actual treatment comparison.
In general, a trial record is most informative when it pairs prespecified methods with numerical estimates and uncertainty. Here, the broad design and endpoint are described, but the numerical primary outcome and key analysis details are not reported in the registry record. The conclusions that can be drawn are therefore limited to what the study set out to compare and the safety counts it records.
13. Why This Trial Matters Statistically
This trial raises a useful statistical distinction between a clinical question and the information available to answer it. The design describes a randomized comparison and names a time-to-event primary endpoint, but the registry record does not include the numerical endpoint results. A clearly stated endpoint is not, on its own, evidence about the direction or size of an outcome difference.
The study also illustrates the interpretive trade-off in pooling treatment groups. Combining the two demcizumab regimens defines the stated primary contrast, but does not show how either schedule performed separately. Readers need to keep the pooled question distinct from questions about each regimen. Separate estimates and uncertainty intervals would be needed to assess those arm-level comparisons.
There is also a reporting distinction between a time-to-event analysis and participant counts. The endpoint is described through Kaplan-Meier estimates of progression-free survival, while the metadata classify it as a participant-count outcome. In general, these summaries represent different ways of describing outcomes. Clear definitions and analysis reporting help readers understand exactly what was measured and how the comparison was made.
Finally, the record shows why statistical interpretation depends on more than whether a trial was randomized or completed. Event definitions, censoring, missing-data handling, analysis populations, and multiplicity procedures all affect how a result should be read. Several of these details are not reported in the registry record. Recognizing those gaps prevents design descriptions and safety counts from being mistaken for a complete account of the primary evidence.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The main limitation for interpreting this trial from the registry record is that numerical results for the primary progression-free survival comparison are not reported. The record gives neither the Kaplan-Meier estimates nor a treatment-effect estimate with an uncertainty interval or test result. The observed event count and analyzed population for this endpoint are also not reported. As a result, the primary comparison’s direction, magnitude, and precision cannot be assessed.
The endpoint description has a metadata ambiguity: it refers to hazard of progression and investigator-assessed Kaplan-Meier estimates of progression-free survival, while the outcome is classified as a participant count. The registry does not clarify how these descriptions fit together. It also does not provide the event definition, progression assessment procedures, censoring rules, or missing-data methods.
The primary comparison pools the demcizumab arms, and separate primary endpoint results for the individual schedules are not reported. The registry does not report the multiplicity strategy, a complete statistical analysis plan, or whether interim analyses or sensitivity analyses were used. These details should not be inferred from the design information.
The serious adverse event summary gives group counts and a list of terms with percentages, but does not state the denominator or arm attribution for those term percentages. The record also does not provide the full safety definitions, exposure-adjusted summaries, or enough follow-up information for a detailed comparative safety interpretation. These limits apply to what is reported in the registry record and do not establish what information may exist elsewhere.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Gemcitabine, Abraxane® Plus Placebo Versus Gemcitabine, Abraxane® Plus 1 or 2 Truncated Courses of Demcizumab in Subjects With 1st-Line Metastatic Pancreatic Ductal Adenocarcinoma — NCT02289898.
- Registry record last updated 2020-09-28; status last verified 2020-09.
- Results first posted 2018-08-08.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
The registry describes NCT02289898 as a completed, randomized, parallel-group phase 2 study sponsored by OncoMed Pharmaceuticals, Inc. It enrolled 207 participants and compared gemcitabine and Abraxane® plus placebo with two regimens adding demcizumab. The trial concerned first-line metastatic pancreatic ductal adenocarcinoma.
The primary outcome is described as investigator-assessed progression-free survival, with Kaplan-Meier estimates comparing the placebo/placebo arm with pooled demcizumab arms in the intention-to-treat population. The timeframe is stated as 2 years, 23 days. Numerical primary endpoint results and key analysis details are not reported in the registry record.
The registry also records serious adverse event counts by group, deaths, and selected serious-event terms. These summaries are descriptive and do not provide a complete comparative safety analysis. The registry’s broad design and endpoint descriptions define the intended question, but the missing numerical results prevent assessment of the primary treatment contrast.