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 Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab (NCT00916617), a non-randomized phase 2 study. The primary outcome is Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00916617 |
| Phase | Phase 2 |
| Condition | Alzheimer Disease |
| Allocation | Non-Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 62 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Pfizer |
| Results posted | Yes |
2. Clinical Question
Population
Participants with mild to moderate Alzheimer’s disease who had taken part in the preceding double-blind study, identified in the record as 3133L1-2203 US. The safety population is defined as all participants who received at least one dose in NCT00916617. The record’s MRI endpoint description also refers to a screening brain MRI consistent with Alzheimer’s disease and a probable Alzheimer’s disease diagnosis according to NINCDS/ADRDA criteria.
Intervention
Subcutaneous bapineuzumab. The study description specifies weekly injections at 5 mg/week, with a planned course of 3 years (156 doses). All participants in the study description were to receive active treatment.
Comparator
No placebo or untreated comparison group is described for this study. Allocation was non-randomized, and the record cautions that the arms are not a like-for-like control comparison. The adverse-event group labels include regimens that are not reconciled with the study description.
Primary question
How many participants had investigator-identified clinically significant MRI findings at scheduled visits or at any visit? The registry record names this as the primary outcome, but does not report the outcome counts. It therefore does not permit an estimate of how often such findings occurred in the study population.
The question is primarily about safety monitoring, not a comparative test of efficacy. Although the study title uses the words safety and efficacy, the listed primary outcome is a count of participants with clinically significant MRI findings. The record also lists pharmacokinetic parameters as a secondary outcome, but no outcome results or analyses are reported for them.
3. Trial Design
NCT00916617 is listed as a Phase 2, parallel-group study sponsored by Pfizer. The registry record gives a planned enrollment of 62 and describes the study as open label, with no masking and non-randomized allocation. These features matter for interpretation: participants and study personnel were not masked to treatment, and assignment was not random. The registry explicitly cautions that the arms should not be treated as a like-for-like control comparison.
The study description says that enrollment was limited to participants in the preceding double-blind study, 3133L1-2203 US. It describes weekly subcutaneous bapineuzumab at 5 mg/week for 3 years (156 doses), with active treatment for all participants and no placebo in this study. The record gives a start date of 2009-06 and a primary completion date of 2012-09, and lists the study status as terminated. These dates do not establish how long each participant received treatment or completed follow-up.
The primary outcome is the number of participants reporting clinically significant MRI findings. Brain MRI was obtained at Week 13 and quarterly thereafter, according to the endpoint description. The outcome was tabulated by visit and treatment group, including an “Any visit” time point. The safety population consists of participants who received at least one dose in this study.
There is an unresolved difference between the study description and the adverse-event group labels. The description specifies a single 5 mg/week active-treatment level and no placebo, while the adverse-event listing names four groups, including placebo-plus-bapineuzumab regimens and other bapineuzumab doses. The record does not explain how those groups relate to the described study treatment. Consequently, their labels should be reported as recorded, not interpreted as proof of randomized treatment arms or a controlled comparison.
The record lists two outcome measures and zero analyses. It does not report a statistical analysis plan, the reasons for termination, or the amount of treatment or follow-up actually completed by participants.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg |
|---|---|---|---|---|
| STARTED | 24 | 21 | 10 | 7 |
| COMPLETED | 1 | 0 | 0 | 0 |
| NOT COMPLETED | 23 | 21 | 10 | 7 |
Reasons for not completing this period:
| Reason | Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg |
|---|---|---|---|---|
| Adverse Event | 3 | 2 | 6 | 3 |
| Withdrawal by Subject | 3 | 2 | 0 | 1 |
| Caregiver Request | 3 | 2 | 1 | 0 |
| Physician Decision | 1 | 1 | 0 | 0 |
| Discontinuation of Study by Sponsor | 8 | 13 | 3 | 1 |
| Lost to Follow-up | 2 | 1 | 0 | 0 |
| Lack of Efficacy | 1 | 0 | 0 | 0 |
| Other | 2 | 0 | 0 | 2 |
Analysis population for the primary outcome, as defined in the registry: The safety population included all participants who received at least 1 dose of study medication in Study NCT00916617.
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: All participants who received at least 1 dose of study medication in study NCT00916617 were included in the safety population.
| Characteristic | Unit | Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg | Total |
|---|---|---|---|---|---|---|
| Participants analysed | 23 | 21 | 10 | 7 | 61 | |
| Age, Continuous | Years | 72.2 (SD 8.92) | 74.0 (SD 9.34) | 80.4 (SD 5.54) | 70.3 (SD 10.13) | 73.9 (SD 9.10) |
| Age, Customized: Less than (<) 65 years | Participants | 4 | 3 | 0 | 2 | 9 |
| Age, Customized: Greater than or equal to (>=) 65 years | Participants | 19 | 18 | 10 | 5 | 52 |
| Sex: Female, Male: Female | Participants | 14 | 8 | 6 | 2 | 30 |
| Sex: Female, Male: Male | Participants | 9 | 13 | 4 | 5 | 31 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Reporting Clinically Significant Magnetic Resonance Imaging (MRI) Findings, measured over Week 13, 26, 39, 52, 65, 78, 91, 104, 117, 130, 143, 156, Any visit.
| 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 reporting clinically significant MRI findings. It is a count of people, rather than a measurement of the number or severity of individual MRI findings. The record says that investigators identified findings as clinically significant and that counts were tabulated by visit and treatment group. Scheduled assessments began at Week 13 and continued quarterly thereafter; an “Any visit” summary was also specified.
In general, repeated MRI monitoring can be used to observe imaging findings over the course of a study, while a participant count expresses how many people met the specified event definition. That count can be useful for describing safety observations, but it does not by itself show when a finding began, whether it persisted, or how severe it was. Those details are not reported in the registry record.
The endpoint description includes screening MRI and diagnostic criteria for Alzheimer’s disease. These are presented as criteria participants were to meet; the registry record does not provide participant-level screening information. It also does not provide the primary endpoint counts at any visit, an estimate across visits, or uncertainty intervals. The named outcome therefore identifies what the study intended to monitor, but the posted record does not establish how many participants experienced the outcome.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry identifies clinically significant MRI findings as the primary outcome, but does not post the corresponding counts. There are no reported estimates by visit or treatment group, and no overall result for “Any visit.” Without those counts, the frequency of the primary outcome cannot be described from this record. No confidence interval, hypothesis test, or other estimate of statistical uncertainty is reported either.
This absence of results should be distinguished from a result showing no MRI findings. The record does not say that there were none; it does not report the outcome values. The registry lists zero analyses, and does not provide an analysis of the primary endpoint. The listed secondary pharmacokinetic outcome likewise has no reported values or analyses.
Study design also limits what can be inferred. Treatment allocation was non-randomized and the study was open label. The registry itself cautions that the arms are not a like-for-like control comparison. Thus, even if group-specific counts were available, the listed design would not support treating a difference between groups as a randomized treatment effect. Participant characteristics, prior study participation, and other factors could differ across groups; the record does not report adjustment methods that could address such differences.
The adverse-event figures are available for four differently labelled groups, but those labels do not match the brief description of a single 5 mg/week active-treatment level with no placebo. The record does not clarify the relationship between those groups and the study described as NCT00916617. The figures can be presented as registry listings, but they should not be combined into a treatment comparison or interpreted as evidence of a dose response.
The status is listed as terminated. That status alone does not explain why the study ended, how much follow-up was completed, or whether termination affected the availability of results. The registry record does not report a reason for termination. It also does not report the planned or actual analysis population for the primary outcome beyond defining the safety population as participants who received at least one dose.
Any sample-size figures associated with planning illustrations should be understood as hypothetical planning calculations, not as observed study results or evidence of achieved power. The stated illustration assumptions use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the target effect expressed as a fraction of the observed effect. The record does not give a trial-specific sample-size justification, and the non-randomized design cautions against reading such illustrations as a validated comparison plan.
9. Statistical Methods Explained
What does a participant count convey?
The primary endpoint is a count of participants with an event: in this case, an investigator-identified clinically significant MRI finding. A count is a direct description of how many people met the recorded definition. It is not the same as a rate over time, a measure of severity, or an estimate of treatment effect. To interpret a count as a proportion, the relevant denominator and the outcome count must both be available for the same population and time point. The registry record names the safety population and scheduled MRI assessments, but does not report the primary outcome counts.
The endpoint includes assessments at multiple visits and an “Any visit” summary. In general, repeated assessments can describe when events are detected during follow-up, while an any-visit count can describe whether a participant was recorded with an event at least once. These summaries answer different questions and should not be substituted for one another. The posted record does not provide values with which to examine either pattern.
What does uncertainty mean?
In general, a confidence interval describes the statistical uncertainty around an estimate under a specified analysis. It helps distinguish a relatively precise estimate from one that remains compatible with a broad range of values. A confidence interval is not a guarantee that the true value lies within its limits, and it does not correct for bias in study design or measurement. No confidence intervals for the primary endpoint are reported in the registry record.
A hypothesis test and its p-value address a different question: how compatible the observed data are with a specified null hypothesis under the assumptions of the test. A p-value is not the probability that a treatment works, and it does not measure the size or practical importance of an effect. The record reports no primary endpoint test or p-value. Because there is no posted primary outcome estimate, there is no basis in this record for discussing statistical significance of that outcome.
Why does allocation matter?
In general, random allocation can help balance measured and unmeasured participant characteristics between treatment groups, on average. Non-randomized allocation does not provide that protection. Group differences can reflect who entered each group, how groups were formed, or other factors, as well as treatment exposure. The record specifies non-randomized allocation and explicitly cautions against treating the arms as a like-for-like control comparison.
Open-label treatment means that masking was absent. In general, knowledge of treatment can affect participant reporting, investigator assessments, additional testing, or event classification. The primary endpoint includes findings identified as clinically significant by the investigator, so the open-label design is relevant to interpretation. This does not establish that any assessment was biased; it identifies a potential source of measurement influence. The registry record does not report an independent blinded review process.
What do the planning assumptions mean?
General sample-size planning estimates the amount of information that might be needed to detect a specified effect under stated assumptions. The registry’s planning illustration is described as being based on an observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The target effect is described as a stated fraction of the observed effect. These are planning assumptions, not a record of the study’s original design justification or a statement of the trial’s observed power.
Planning estimates are sensitive to the assumed effect size and analysis model. If the effect used for planning is uncertain, a resulting sample-size illustration is uncertain too. The record does not give the trial’s own sample-size justification or establish that the study was designed around the primary MRI endpoint. Any planning illustration should therefore be kept separate from the absent primary outcome results.
Why is the record insufficient for an adjusted analysis?
An adjusted analysis uses participant or study characteristics to account for differences relevant to the outcome. In general, adjustment can address measured differences when the model and available data are appropriate, but it cannot automatically remove bias from unmeasured factors. The registry record reports no analyses and does not describe covariates, model specifications, or adjusted estimates. It is not possible to infer that any adjustment was performed.
The record also does not describe how repeated observations, missing MRI assessments, or participants with different amounts of follow-up were handled. These choices can affect estimates from longitudinal safety monitoring. Without outcome counts and analysis details, no statistical method can be reconstructed from the registry entry. The appropriate reading is descriptive: the registry specifies what was intended to be counted, but it does not post the primary results or the analysis needed to quantify them.
10. Multiplicity, Missing Data and Analysis Populations
The endpoint description specifies MRI assessments at multiple visits and an “Any visit” summary. Looking at several visits creates multiple opportunities to describe or test outcomes. In general, when multiple statistical tests are conducted, the chance of at least one apparently notable result can increase unless the analysis plan addresses multiplicity. The registry record does not report a multiplicity strategy, a hierarchy of outcomes, or a plan identifying which visit-specific result would be primary for testing. Since it reports zero analyses and no endpoint results, the effect of any multiplicity approach cannot be assessed.
The record defines the safety population as all participants who received at least one dose of study medication. It does not report how many participants were included in a primary endpoint analysis, whether every participant had MRI data at each scheduled assessment, or how participants with incomplete follow-up were handled. Missing-data methods, reasons for missing assessments, and sensitivity analyses are not reported in the registry record. Consequently, the degree to which the posted outcome—if available—would represent all enrolled participants could not be evaluated from this entry.
The record also does not describe an intention-to-treat population or any alternative efficacy analysis population. It does not state how participants who stopped treatment, withdrew, or missed visits would contribute to the MRI summaries. These omissions do not establish that the study failed to use such methods; they mean that the registry record does not report them. The primary outcome results and analysis population are not reported, so no claim about completeness or robustness of the endpoint analysis is supported.
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 |
|---|---|---|---|
| Bapineuzumab (5 mg + 5 mg) | 4 | 23 | 17.4% |
| Bapineuzumab (10 mg + 10 mg) | 5 | 21 | 23.8% |
| Placebo + Bapineuzumab 5mg | 7 | 10 | 70.0% |
| Placebo + Bapineuzumab 10 mg | 2 | 7 | 28.6% |
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 |
|---|---|
| Bapineuzumab (5 mg + 5 mg) | 19 of 23 |
| Bapineuzumab (10 mg + 10 mg) | 16 of 21 |
| Placebo + Bapineuzumab 5mg | 10 of 10 |
| Placebo + Bapineuzumab 10 mg | 6 of 7 |
Most frequent serious adverse event terms
| Event term | Organ system | Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg |
|---|---|---|---|---|---|
| Gastroenteritis | Infections and infestations | 0 of 23 | 0 of 21 | 1 of 10 | 1 of 7 |
| Dehydration | Metabolism and nutrition disorders | 0 of 23 | 0 of 21 | 2 of 10 | 0 of 7 |
| Angina pectoris | Cardiac disorders | 0 of 23 | 0 of 21 | 1 of 10 | 0 of 7 |
| Atrial flutter | Cardiac disorders | 0 of 23 | 0 of 21 | 1 of 10 | 0 of 7 |
| Myocardial infarction | Cardiac disorders | 1 of 23 | 0 of 21 | 0 of 10 | 0 of 7 |
| Abdominal pain | Gastrointestinal disorders | 1 of 23 | 0 of 21 | 0 of 10 | 0 of 7 |
| Diarrhoea | Gastrointestinal disorders | 0 of 23 | 0 of 21 | 1 of 10 | 0 of 7 |
| Intestinal obstruction | Gastrointestinal disorders | 0 of 23 | 1 of 21 | 0 of 10 | 0 of 7 |
| Melaena | Gastrointestinal disorders | 1 of 23 | 0 of 21 | 0 of 10 | 0 of 7 |
| Asthenia | General disorders | 1 of 23 | 0 of 21 | 0 of 10 | 0 of 7 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Bapineuzumab (5 mg + 5 mg) | Bapineuzumab (10 mg + 10 mg) | Placebo + Bapineuzumab 5mg | Placebo + Bapineuzumab 10 mg |
|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 6 of 23 | 4 of 21 | 1 of 10 | 0 of 7 |
| Back pain | Musculoskeletal and connective tissue disorders | 2 of 23 | 4 of 21 | 2 of 10 | 2 of 7 |
| Fall | Injury, poisoning and procedural complications | 1 of 23 | 4 of 21 | 2 of 10 | 2 of 7 |
| Gait disturbance | General disorders | 2 of 23 | 3 of 21 | 1 of 10 | 0 of 7 |
| Urinary tract infection | Infections and infestations | 2 of 23 | 1 of 21 | 2 of 10 | 1 of 7 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 4 of 23 | 0 of 21 | 1 of 10 | 1 of 7 |
| Vasogenic cerebral oedema | Nervous system disorders | 3 of 23 | 0 of 21 | 2 of 10 | 1 of 7 |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | 2 of 23 | 0 of 21 | 3 of 10 | 0 of 7 |
| Hiatus hernia | Gastrointestinal disorders | 2 of 23 | 0 of 21 | 3 of 10 | 0 of 7 |
| Vomiting | Gastrointestinal disorders | 0 of 23 | 2 of 21 | 2 of 10 | 1 of 7 |
Serious events with the highest arm-level rate: dehydration (20.0%), gastroenteritis (14.3%), prostate cancer (14.3%), angina pectoris (10.0%), atrial flutter (10.0%).
The adverse-event listing gives four named groups, with participants at risk and participants affected for serious events and for other events. For “Bapineuzumab (5 mg + 5 mg),” the listing reports 23 at risk and 4 with a serious event, and 23 at risk and 19 with another event. For “Bapineuzumab (10 mg + 10 mg),” it reports 21 at risk and 5 with a serious event, and 21 at risk and 16 with another event.
For “Placebo + Bapineuzumab 5mg,” the listing reports 10 at risk and 7 with a serious event, and 10 at risk and 10 with another event. For “Placebo + Bapineuzumab 10 mg,” it reports 7 at risk and 2 with a serious event, and 7 at risk and 6 with another event. Death counts are not reported in the registry record.
The most frequently listed serious-event terms and percentages are Dehydration, 20.0%; Gastroenteritis, 14.3%; Prostate cancer, 14.3%; Angina pectoris, 10.0%; Atrial flutter, 10.0%; and Diarrhoea, 10.0%. The record does not provide further context for interpreting these percentages. An event recorded during a study is not, on its own, proof that treatment caused it. The group labels also differ from the study description, which specifies one active dose and no placebo, and the relationship is not explained. These counts should therefore be read as registry-reported safety listings, not as a controlled comparison.
12. What the Result Does, and Does Not, Mean
The registry record establishes that this Phase 2 study was designed to monitor long-term safety and tolerability of subcutaneous bapineuzumab, with clinically significant MRI findings named as the primary outcome. It describes an open-label, non-randomized, parallel-group study and specifies that participants were to receive active treatment. It also provides a definition of the safety population and a schedule for MRI assessments.
However, the record does not report the primary MRI outcome counts, any estimates of uncertainty, or analyses of the primary endpoint. It therefore cannot establish from the posted results how many participants had clinically significant MRI findings. The missing result must not be interpreted as zero events, as evidence of safety, or as evidence of harm. Likewise, the record’s title does not substitute for reported efficacy results, and no efficacy conclusion can be drawn from the information posted.
The adverse-event counts provide descriptive information under four group labels. They do not resolve the mismatch between those labels and the study description, and the non-randomized design does not support treating the groups as comparable controls. The counts alone also do not establish that an event was caused by bapineuzumab. The death values are not reported in the registry record.
The study is listed as terminated, but the record does not state why it was terminated or what effect termination had on treatment exposure, follow-up, or analysis. The planned course of 3 years (156 doses) should not be read as the duration actually completed by every participant. In sum, the registry describes the intended monitoring and offers some adverse-event listings, but does not post the primary outcome results needed to quantify the central MRI safety question.
13. Why This Trial Matters Statistically
This study illustrates a common distinction in clinical-trial interpretation: a registry can describe a carefully specified outcome without reporting the observations needed to answer it. Here, the primary measure is identifiable, the assessment schedule is described, and the safety population is defined. Yet the endpoint counts and analyses are absent. Statistical interpretation must begin by checking whether the result itself is available, before considering comparisons, uncertainty, or clinical meaning.
The design details also show why the label “parallel group” is not enough to establish a valid treatment comparison. Allocation was non-randomized, masking was absent, and the registry cautions that arms are not like-for-like controls. Those details affect the kinds of conclusions that could be drawn even if group-specific results were posted. A difference between groups could not automatically be attributed to treatment.
The inconsistent treatment descriptions are another practical issue. The study summary describes one weekly dose and no placebo, while the adverse-event listing names multiple regimens, including placebo combinations. Recognizing and preserving that discrepancy is more reliable than silently treating the adverse-event groups as the study’s randomized arms.
Finally, this record highlights the need to separate planned treatment from completed treatment, and planning illustrations from observed trial performance. A planned course does not establish actual exposure, and a sample-size illustration is not observed power. These distinctions help prevent the registry’s design language and safety counts from being made to answer questions that the posted results do not resolve.
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 most important limitation for interpreting this specific registry entry is that it does not report the primary outcome counts or analyses. The intended MRI monitoring schedule is described, but the frequency of clinically significant findings cannot be determined. The record also does not give confidence intervals, statistical tests, or estimates for the listed secondary pharmacokinetic outcome.
The study was non-randomized and open label. The registry warns that the arms are not a like-for-like control comparison. The primary endpoint depends on investigator identification of clinically significant MRI findings, and the record does not describe blinded or independent review. These design features constrain causal interpretation, although the record does not establish that an assessment was biased.
The intervention descriptions are inconsistent across the study summary and adverse-event group labels. The record does not explain how the four adverse-event groups relate to the described 5 mg/week study with no placebo. This prevents a clear mapping of those safety listings to the stated study regimen. The denominators and event counts should not be used to infer comparative treatment effects.
The status is terminated, but the reason is not reported. Actual treatment duration, completeness of follow-up, and handling of missing MRI visits are also not reported. Although the safety population is defined as participants receiving at least one dose, the record does not state the analysis population used for the primary endpoint. These limitations leave important questions about outcome availability and follow-up unresolved.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study Evaluating The Long-Term Safety And Efficacy Of Subcutaneous Bapineuzumab — NCT00916617.
- Registry record last updated 2017-06-01; status last verified 2017-04.
- Results first posted 2017-06-01.
- 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
NCT00916617 is a Phase 2, open-label, non-randomized, parallel-group study of subcutaneous bapineuzumab in participants with mild to moderate Alzheimer’s disease. The study description specifies weekly 5 mg/week treatment for a planned 3 years (156 doses), and says that all participants were to receive active treatment. The registry lists enrollment of 62, a start date of 2009-06, a primary completion date of 2012-09, and terminated status.
The primary outcome is the number of participants reporting clinically significant MRI findings, assessed at Week 13 and quarterly thereafter, with an “Any visit” summary. The registry record does not report the primary outcome counts or analyses. Adverse-event listings are reported for four groups, but their relationship to the study description is not explained. The record does not report the reason for termination, methods for missing data, or a trial-specific sample-size justification.