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 Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease (NCT00619489), a non-randomized phase 2 study. The primary outcome is Number of Participants With Adverse Events (AEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00619489 |
| Phase | Phase 2 |
| Condition | Ulcerative Colitis, Crohn's Disease |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 72 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Millennium Pharmaceuticals, Inc. |
| Results posted | Yes |
2. Clinical Question
Population
The study included people with ulcerative colitis or Crohn's disease. It offered continued treatment to participants with ulcerative colitis who had completed Study C13002, as well as treatment-naïve participants with either disease. The safety analysis set was defined as enrolled participants who received at least one dose of study drug.
Intervention
Participants received intravenous vedolizumab in a 2 mg/kg or 6 mg/kg dose group. Treatment began with doses on Days 1, 15 and 43, followed by dosing every 8 weeks for up to 78 weeks.
Comparator
The record describes non-randomized dose groups and no like-for-like control comparison. The groups should not be read as randomized treatment arms, and the registry record does not report a separate untreated or placebo comparator.
Primary question
The primary endpoint was the number of participants with adverse events from Day 1 to Day 637. The study aimed to describe long-term safety during vedolizumab treatment. Its open-label, non-randomized structure supports a descriptive reading of recorded events, not a causal comparison of doses.
The safety question is about whether adverse events occurred during the recorded treatment period and how they were characterized. The registry defines an adverse event as an untoward medical occurrence after administration of a pharmaceutical product; the event need not have been caused by the treatment. Investigators collected information on outcome, severity, relationship to study drug and whether the event met the criteria for a serious adverse event.
The registry also describes participants with ulcerative colitis and Crohn's disease in the same study. It does not provide a disease-specific primary safety estimate in the registry record reported for this record. Consequently, the overall endpoint should not be taken to answer whether event patterns differ by diagnosis, prior treatment experience or dose. Those subgroup comparisons are not reported in the registry record.
3. Trial Design
This was a phase 2, multiple-dose, open-label, non-randomized, parallel study of vedolizumab. The registry lists an enrollment of 72 and a completed status. The study began in 2007-12, and primary completion was recorded in 2010-03. The sponsor was Millennium Pharmaceuticals, Inc.
The stated purpose was to offer vedolizumab treatment to participants with ulcerative colitis who had completed Study C13002, and to treatment-naïve participants with ulcerative colitis or Crohn's disease, while determining long-term safety. The two dose groups were vedolizumab 2 mg/kg and vedolizumab 6 mg/kg. In both, treatment was intravenous on Days 1, 15 and 43, then once every 8 weeks for up to 78 weeks.
Open-label means that treatment assignment was not masked. Non-randomized allocation means participants were not assigned to the dose groups by random allocation, according to the registry. The record does not report the process used to place participants in each group. These design features matter because differences between groups could reflect characteristics of the participants, their prior treatment or other factors, as well as dose. The groups are therefore not a like-for-like control comparison.
The safety analysis set included enrolled participants who received at least one dose of study drug. The record says the analysis was based on the lowest dose received rather than dose at randomization. That wording should be retained when interpreting which group participants contribute to; details of how this rule was applied are not reported in the registry record. The posted information describes seven outcome measures, including measures of serum vedolizumab concentration and receptor saturation. A detailed statistical analysis plan is 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: Treatment-naïve ulcerative colitis (UC) or Crohn's Disease (CD) participants were assigned to receive 6.0 mg/kg vedolizumab. Participants who rolled over from Study C13002 (NCT01177228) were assigned to receive 2.0 mg/kg vedolizumab.
Overall Study
| Stage | Vedolizumab 2 mg/kg | Vedolizumab 6 mg/kg |
|---|---|---|
| STARTED | 37 | 35 |
| COMPLETED | 14 | 1 |
| NOT COMPLETED | 23 | 34 |
Reasons for not completing this period:
| Reason | Vedolizumab 2 mg/kg | Vedolizumab 6 mg/kg |
|---|---|---|
| Adverse Event | 0 | 7 |
| Withdrawal by Subject | 1 | 1 |
| Lack of Efficacy | 0 | 11 |
| Rolled over to Study C13008 (NCT00790933 | 22 | 15 |
Analysis population for the primary outcome, as defined in the registry: Safety analysis set, defined as all enrolled participants who received at least 1 dose of study drug. Analysis was based on the lowest dose received, rather than dose at randomization.
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.
Population: The Safety Analysis Set defined as all enrolled participants who received at least 1 dose of study drug. Patients were analyzed based on the lowest dose they received. Baseline is the time closest to, but before, the start of study drug administration; for participants who rolled over from Study C13002 Baseline data are from the C13002 dataset.
| Characteristic | Unit | Vedolizumab 2 mg/kg | Vedolizumab 6 mg/kg | Total |
|---|---|---|---|---|
| Participants analysed | 37 | 35 | 72 | |
| Age, Continuous | years | 42.0 (SD 11.06) | 42.1 (SD 15.79) | 42.1 (SD 13.47) |
| Sex: Female, Male: Female | Participants | 21 | 22 | 43 |
| Sex: Female, Male: Male | Participants | 16 | 13 | 29 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 | 0 | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 37 | 34 | 71 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 1 | 1 |
| Race/Ethnicity, Customized: White | participants | 37 | 34 | 71 |
| Race/Ethnicity, Customized: American Indian or Alaskan Native | participants | 0 | 1 | 1 |
| Height | cm | 168.9 (SD 8.83) | 168.4 (SD 11.49) | 168.7 (SD 10.14) |
| Weight | kg | 77.03 (SD 17.620) | 70.81 (SD 17.820) | 74.01 (SD 17.868) |
| Body Mass Index (BMI) | kg/m^2 | 27.04 (SD 6.045) | 24.86 (SD 5.286) | 25.98 (SD 5.754) |
| Body Surface Area (BSA) | m^2 | 1.89 (SD 0.233) | 1.81 (SD 0.270) | 1.85 (SD 0.253) |
| Inflammatory Bowel Disease Type: Crohn's Disease | participants | 0 | 19 | 19 |
| Inflammatory Bowel Disease Type: Ulcerative Colitis | participants | 37 | 16 | 53 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events (AEs), measured over From Day 1 to Day 637.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with adverse events from Day 1 to Day 637. It is a count of participants meeting the event definition during the stated period, rather than a measure of event severity alone, event duration or the rate of events per unit of treatment exposure. The registry identifies the analysis population as the safety analysis set: enrolled participants who received at least one dose.
An adverse event is defined broadly as an untoward medical occurrence in a person administered a pharmaceutical product, whether or not it is causally related to treatment. Investigators collected information intended to characterize the event's outcome and severity, its assessed relationship to the drug, and whether it met serious adverse event criteria. A serious adverse event was defined by outcomes or risks including death, inpatient hospitalization or prolongation of hospitalization, and congenital, persistent or significant disability or incapacity.
Severity and seriousness are distinct concepts in the record. Intensity was categorized as mild, moderate or severe using descriptions based on awareness and tolerability, interference with daily activities, or inability to perform normal daily activities. Seriousness instead depends on specified outcomes or risks. An event can therefore be discussed by its intensity and by whether it meets the serious-event definition; those labels are not interchangeable.
Counting participants with events is useful for describing how many people in the safety population experienced an event during follow-up. It does not, by itself, show how many events each person had, how long participants were exposed, or whether the drug caused the events. An overall primary endpoint estimate is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a safety study rather than a randomized efficacy comparison. Its primary endpoint concerns participants with adverse events during treatment, and the posted safety information includes serious and other adverse-event counts by dose group. For serious adverse events, the record lists 3 affected participants among 37 at risk in the 2 mg/kg group and 7 among 35 at risk in the 6 mg/kg group. For other adverse events, it lists 12 among 37 at risk and 27 among 35 at risk, respectively. These are descriptive counts within the recorded groups.
The groups cannot be treated as interchangeable populations. Allocation was non-randomized, and the registry does not report how participants entered each dose group. Differences in their observed counts could be associated with factors other than dose, including differences in participant characteristics or treatment history. The study also included participants with two diseases and both previously treated and treatment-naïve participants. The record does not report enough information to separate those influences in the displayed summaries.
The seriousness counts should be read using the registry's definition of a serious adverse event, which includes specified outcomes or risks. They are not counts of all adverse events, and they do not indicate that an event was judged to be caused by vedolizumab. The endpoint definition explicitly says an adverse event need not have a causal relationship with the treatment. The other-event counts should likewise be interpreted according to the categories recorded, rather than as proof of a treatment effect.
The registry lists six serious-event terms at 2.9% each: abdominal abscess, Salmonella sepsis, viral infection, small intestinal obstruction, Crohn's disease and vision blurred. The denominator and the event-term counting method for these percentages are not reported in the registry record. The listed terms therefore provide a description of reported serious events, not a basis for estimating comparative risk or establishing causality.
No confidence intervals, hypothesis tests, adjusted comparisons or model-based estimates are reported in the registry record. Without such estimates, the precision of differences between groups cannot be assessed from the posted information. Even when a confidence interval is available, it describes statistical uncertainty under its assumptions; it does not resolve bias from non-random allocation or establish that an event was caused by treatment.
The registry includes planning illustrations based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. Such figures are planning illustrations, not observed power and not evidence that the study was designed to detect a particular safety difference. The record's own sample-size justification is not reported in the registry record. No numerical planning result should be mistaken for a trial outcome.
Overall, the posted data describe events recorded in the safety analysis set. They do not establish that the dose groups had comparable baseline risk, that a difference in their counts was caused by dose, or that the absence of a reported estimate means an event did not occur. Interpretation is limited to descriptive safety information and the definitions and populations stated in the record.
9. Statistical Methods Explained
Safety outcomes are often summarized as counts of participants who experienced an event. This is a participant-level summary: a participant who experiences an event contributes to the count, while the summary does not convey how many separate episodes that participant had. Such a measure can be easy to interpret, but its meaning depends on the event definition, follow-up period, analysis population and completeness of reporting.
What does a participant count tell the reader?
A count paired with the number at risk describes observed event experience within the recorded group. It does not automatically estimate a causal treatment effect. In a randomized study, random assignment can support comparisons by balancing characteristics on average, subject to chance and study conduct. This study was non-randomized, so the recorded groups may differ in ways that matter to event risk. A direct contrast of their counts cannot separate dose-related effects from those other differences without suitable design and analysis information.
A participant count also does not account for differences in time exposed. The study allowed treatment for up to 78 weeks, and the primary endpoint timeframe runs from Day 1 to Day 637. The registry does not report participant-level follow-up duration, exposure-adjusted event rates or how missing follow-up was handled. If time under observation varies, a simple count may not describe event frequency over exposure in the same way that a rate would.
How are adverse events classified?
The registry's adverse-event definition does not require a causal relationship to study drug. This is important in safety reporting: events occurring after treatment are recorded for assessment, but chronology alone does not show that treatment caused them. Investigators collected information about outcome, severity, drug relationship and seriousness. The record distinguishes intensity descriptions from serious-event criteria. Seriousness refers to specified consequences or risks, while intensity refers to how the event affected the participant.
Classification can affect what a count means. A count of participants with any adverse event is broader than a count of participants with serious adverse events. Terms listed as serious events are event descriptions; they do not themselves establish causality, severity beyond the stated classification, or comparative risk. The registry record does not report the denominator or counting conventions for the listed serious-event percentages, so those percentages should be taken as reported rather than reverse-engineered.
What is the role of a confidence interval?
In general, a confidence interval expresses the statistical uncertainty around an estimate under a specified method and its assumptions. A narrow interval indicates greater statistical precision than a wide interval, but precision is not the same as freedom from bias. A confidence interval around a comparison between non-randomized groups would not, by itself, correct for differences in participant characteristics or treatment history. The registry record does not report confidence intervals for the primary endpoint or the adverse-event summaries.
Likewise, a significance test addresses compatibility of data with a statistical null hypothesis under a model. It does not measure clinical importance, prove causation, or confirm that groups are comparable. No primary endpoint test or adjusted comparison is reported in the registry record. It is therefore not appropriate to infer statistical significance from the raw counts alone.
Why do allocation and analysis population matter?
The safety set consists of enrolled participants who received at least one dose. This is a treatment-exposed population, not necessarily the same as all enrolled participants. The registry says that analysis was based on the lowest dose received rather than dose at randomization, even though allocation is described as non-randomized. The record does not explain the practical application of that rule. This detail matters because group membership determines which denominator and event count are interpreted together.
In general, an analysis population should be stated clearly because excluding people or assigning them to groups in different ways can change a safety summary. For an exposure-based safety analysis, including people who received treatment may be appropriate for describing events after exposure, but it does not answer the same question as an analysis of everyone enrolled. The registry does not report a separate analysis population or sensitivity analysis for the primary endpoint.
What do the planning assumptions mean?
The registry's sample-size assumptions describe planning illustrations using a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a fraction of the observed effect. These are generic design inputs, not observed trial outcomes. An illustration based on an observed effect can show how a hypothetical future study might be planned under stated assumptions, but it is not the study's observed power and does not establish that the original study had adequate power.
Normal approximations can be convenient, but their suitability depends on the outcome and data structure. For sparse binary outcomes, approximations may not represent uncertainty well. Planning calculations also depend on the assumed effect, allocation, significance threshold and other design choices. The registry record does not report a protocol-based sample-size justification, a detailed statistical plan or interim-analysis procedures. Those items should not be inferred from the planning assumptions alone.
Multiplicity is a concern when many outcomes or comparisons are examined, because repeated testing can increase the chance of a misleading positive finding. The registry lists seven outcome measures, including secondary measures of serum concentration and receptor saturation, but no analysis results or multiplicity procedure are reported. A reader should not assume that all outcomes were tested, that testing was adjusted, or that a particular outcome hierarchy was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists seven outcome measures, including the primary count of participants with adverse events and secondary measures concerning serum vedolizumab concentration and receptor saturation. It does not report a multiplicity adjustment, a prespecified hierarchy for testing outcomes, or a complete statistical analysis plan. Where several outcomes or comparisons are considered, multiplicity can make isolated findings harder to interpret; without the analysis plan, the intended handling of that issue is not reported in the registry record.
Missing-data methods are also not reported in the registry record. The record defines the safety analysis set as enrolled participants who received at least one dose, but does not explain how incomplete follow-up, missing event assessments, withdrawals or differing exposure durations were handled. A participant who leaves observation may have less opportunity for an event to be recorded, so the handling of incomplete data is relevant to interpreting counts over the stated timeframe.
The analysis population is described as based on the lowest dose received rather than dose at randomization. Because allocation is non-randomized, the phrase about randomization does not explain how the group assignment rule operated in practice. Further details are not reported in the registry record. The record also does not report a separate intention-to-treat analysis, sensitivity analyses, adjusted estimates or interim analyses. These omissions do not prove that such procedures were absent from study conduct; they mean that their use cannot be established 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 |
|---|---|---|---|
| Vedolizumab 2 mg/kg | 3 | 37 | 8.1% |
| Vedolizumab 6 mg/kg | 7 | 35 | 20.0% |
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 |
|---|---|
| Vedolizumab 2 mg/kg | 12 of 37 |
| Vedolizumab 6 mg/kg | 27 of 35 |
Most frequent serious adverse event terms
| Event term | Organ system | Vedolizumab 2 mg/kg | Vedolizumab 6 mg/kg |
|---|---|---|---|
| Abdominal abscess | Infections and infestations | 0 of 37 | 1 of 35 |
| Salmonella sepsis | Infections and infestations | 0 of 37 | 1 of 35 |
| Furuncle | Infections and infestations | 1 of 37 | 0 of 35 |
| Viral infection | Infections and infestations | 0 of 37 | 1 of 35 |
| Colitis ulcerative | Gastrointestinal disorders | 1 of 37 | 0 of 35 |
| Small intestinal obstruction | Gastrointestinal disorders | 0 of 37 | 1 of 35 |
| Crohn's disease | Gastrointestinal disorders | 0 of 37 | 1 of 35 |
| Vision blurred | Eye disorders | 0 of 37 | 1 of 35 |
| Infusion-related reaction | General disorders | 0 of 37 | 1 of 35 |
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | 0 of 37 | 1 of 35 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Vedolizumab 2 mg/kg | Vedolizumab 6 mg/kg |
|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 5 of 37 | 7 of 35 |
| Headache | Nervous system disorders | 2 of 37 | 7 of 35 |
| Cough | Respiratory, thoracic and mediastinal disorders | 1 of 37 | 5 of 35 |
| Influenza | Infections and infestations | 1 of 37 | 3 of 35 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 1 of 37 | 3 of 35 |
| Upper respiratory tract infection | Infections and infestations | 1 of 37 | 2 of 35 |
| Crohn's disease | Gastrointestinal disorders | 0 of 37 | 3 of 35 |
| Nausea | Gastrointestinal disorders | 0 of 37 | 3 of 35 |
| Vomiting | Gastrointestinal disorders | 0 of 37 | 3 of 35 |
| Respiratory tract infection viral | Infections and infestations | 2 of 37 | 0 of 35 |
Serious events with the highest arm-level rate: abdominal abscess (2.9%), salmonella sepsis (2.9%), viral infection (2.9%), small intestinal obstruction (2.9%), crohn's disease (2.9%).
The serious adverse-event counts are 3 of 37 participants at risk in the vedolizumab 2 mg/kg group and 7 of 35 in the vedolizumab 6 mg/kg group. The other adverse-event counts are 12 of 37 and 27 of 35, respectively. These are descriptive summaries for the listed groups and should not be read as a randomized comparison: allocation was non-randomized, and the record does not report the process used to determine group membership.
Seriousness follows the registry's criteria, including events resulting in or posing risk for death, inpatient hospitalization or prolonged hospitalization, or specified disability outcomes. Seriousness is not the same as intensity. The record also states that adverse events do not necessarily have a causal relationship with treatment. Thus, a recorded serious event is not automatically a treatment-caused event.
The listed serious-event terms are reported at 2.9% each. Their denominator and counting method are not reported in the registry record. They should be treated as reported event descriptions, not as comparative estimates or causal findings. The counts also do not describe event rates adjusted for treatment exposure or account for unreported follow-up.
12. What the Result Does, and Does Not, Mean
The registry record documents a phase 2, open-label study designed to provide vedolizumab treatment and assess long-term safety in participants with ulcerative colitis or Crohn's disease. The posted safety summaries show recorded adverse events in the two non-randomized dose groups, including the stated counts of participants with serious and other adverse events. These observations can describe what was recorded in the safety population under the study's definitions.
They do not establish that vedolizumab caused the recorded events. The registry defines adverse events without requiring a causal link to treatment, and provides no basis in the posted information for separating background illness and other causes from treatment-associated events. Nor do the group counts establish that one dose caused more or fewer events than the other. Non-random allocation permits differences between groups that could affect observed event counts.
The summaries also do not establish how event risk would compare with no treatment or another treatment. No like-for-like control group is reported. They do not provide a complete account of each participant's exposure or follow-up, and the registry record does not report missing-data methods, confidence intervals or adjusted analyses. Those limits restrict conclusions about the precision and generalizability of the counts.
Absence of a reported endpoint estimate or statistical test should not be interpreted as evidence that an event did not occur, or that groups were equivalent. Conversely, a difference between raw group counts should not be treated as proof of a dose effect. The registry supports a descriptive account of adverse events recorded during treatment, interpreted within the study population, follow-up period and classification rules. Further claims about causal effects, comparative safety or disease-specific patterns are not reported in the registry record.
13. Why This Trial Matters Statistically
This study is statistically useful as an example of how safety endpoints differ from efficacy comparisons. The primary outcome counts participants with adverse events during a defined period. Such a count is clinically interpretable as a description of recorded events, but it is sensitive to the population included, follow-up completeness, exposure duration and event definitions. These considerations are especially important when the groups were not formed through random allocation.
The record illustrates why a larger event count in one group does not, on its own, demonstrate a treatment-related difference. Participants may enter dose groups with different characteristics, and the registry does not describe the group-assignment process. A descriptive safety summary is valuable, but causal interpretation requires more than comparing counts. Design, analysis, follow-up and transparent reporting all contribute to how much can be learned.
The record also makes an important distinction between an adverse event and an event caused by treatment. Broad event collection is part of safety monitoring, while causality is a separate assessment. Seriousness and intensity are also separate classifications. Keeping those concepts distinct prevents a count of serious events from being mistaken for a count of all events, or a reported event from being treated as proof of harm caused by the drug.
Finally, the study highlights the difference between planning illustrations and evidence generated by the trial. Sample-size planning depends on assumptions, whereas observed results describe the data collected. Without the protocol-based justification, analysis plan and uncertainty estimates in the registry record, planning figures cannot substitute for a transparent account of the design or the precision of observed results.
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 interpretation is non-randomized allocation. The dose groups are not a like-for-like control comparison, and the registry record does not report how participants were assigned to a dose. Differences in observed adverse-event counts may reflect group composition or other influences, not necessarily dose. The open-label design also means treatment was not masked; the record does not report procedures to reduce any influence of knowledge of treatment on event assessment.
The study combined participants with ulcerative colitis and Crohn's disease, including people who had completed an earlier study and treatment-naïve participants. Disease-specific and treatment-history-specific endpoint estimates are not reported in the registry record. The safety set includes participants who received at least one dose, but the record does not describe how follow-up differed across participants or how incomplete event data were handled.
The registry does not report a confidence interval, adjusted comparison, hypothesis test or detailed analysis plan for the primary endpoint. It also does not report the denominator or counting method for the listed serious-event percentages. As a result, the precision of the descriptive findings and the interpretation of those percentages are limited. A protocol-based sample-size justification and interim-analysis procedures are not reported in the registry record.
These limits concern what can be concluded from the registry record; they do not establish what procedures may have been used outside the reported information. The counts remain useful as descriptive safety observations, but they cannot alone establish causation, comparative dose effects or results for populations not characterized in the record.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Long Term Safety of Vedolizumab (MLN0002) in Patients With Ulcerative Colitis and Crohn's Disease — NCT00619489.
- Registry record last updated 2014-07-18; status last verified 2014-06.
- Results first posted 2014-07-18.
- 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
Use this trial's endpoint as a starting point for deeper study of effect measures, confidence intervals, and sample-size planning.
18. Record Summary
NCT00619489 is a completed phase 2, multiple-dose, open-label, non-randomized parallel study of vedolizumab in participants with ulcerative colitis or Crohn's disease. The registry lists enrollment of 72, a start in 2007-12 and primary completion in 2010-03. The dose groups received 2 mg/kg or 6 mg/kg intravenously on Days 1, 15 and 43, then every 8 weeks for up to 78 weeks.
The primary outcome was the number of participants with adverse events from Day 1 to Day 637, assessed in a safety population of enrolled participants who received at least one dose. The posted adverse-event data include serious-event counts of 3 among 37 at risk in the 2 mg/kg group and 7 among 35 in the 6 mg/kg group. Because allocation was non-randomized and the record does not report inferential analyses, these figures are descriptive rather than causal comparative estimates. Further details on missing data, multiplicity and the statistical analysis plan are not reported in the registry record.