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 Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2) (NCT00723827), a registered phase not stated study. The primary outcome is Number of Participants Experiencing Adverse Events (AEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT00723827 |
| Phase | Phase not stated |
| Condition | Glioblastoma, Glioma, Astrocytoma |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 682 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Merck Sharp & Dohme LLC |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes participants with newly diagnosed glioblastoma multiforme, as well as participants with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, whose disease had recurred or progressed after standard therapy. The reported enrollment was 682 participants. Further eligibility criteria and participant characteristics are not reported in the registry record.
Intervention
The intervention was temozolomide, named in the record as Temodal. For participants with newly diagnosed glioblastoma multiforme, the arm description says treatment was temozolomide with radiotherapy. For participants with recurrent or progressive malignant glioma after standard therapy, it describes temozolomide treatment. Dosing and treatment schedules are not reported in the registry record.
Comparator
The registry describes one group, called All Participants, and does not report a separate control group. It characterizes the study as not being a randomized comparison; allocation is not stated. Consequently, the record does not set out a like-for-like comparison of temozolomide against another treatment or against no treatment.
Primary question
The primary outcome counts participants experiencing adverse events during the complete study duration and for 30 days after completion, up to approximately 7.5 months. The surveillance purpose was to assess postmarketing safety and efficacy under actual conditions of use, including serious and nonserious adverse events, unexpected adverse drug reactions, events associated with misuse, abuse, or interactions, and other safety or efficacy information. The posted primary result is a count of participants with adverse events, not a comparative estimate of treatment effect.
3. Trial Design
NCT00723827 is titled a Temodal (temozolomide) postmarketing surveillance protocol. The record lists Merck Sharp & Dohme LLC as sponsor, a start date of 2008-03, primary completion in 2011-09, and a completed status. Enrollment was 682. These details place the study in a postmarketing surveillance context, but the registry record does not provide a fuller design classification or a detailed protocol description.
The arm description groups all participants together while distinguishing treatment circumstances: newly diagnosed glioblastoma multiforme was treated with temozolomide and radiotherapy, while recurrent or progressive malignant glioma after standard therapy was treated with temozolomide. The intervention list names both temozolomide and radiotherapy. These descriptions do not establish a randomized allocation or a controlled comparison. The record explicitly indicates that this is not a randomized comparison and that allocation is not stated.
The surveillance was intended to examine safety and efficacy under actual conditions of use. The posted primary outcome is the number of participants experiencing adverse events during the complete study duration and for 30 days after completion, up to approximately 7.5 months. The registry lists five outcome measures, but the record does not report the detailed results for the other measures in the registry record for this account. It lists no statistical analyses.
The available design information therefore supports a descriptive reading of the adverse-event counts in the enrolled group. It does not support a causal comparison between treatment strategies. Details such as dosing, follow-up procedures, eligibility rules beyond the arm description, and methods for collecting or adjudicating events are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Overall Study
| Stage | All Participants |
|---|---|
| STARTED | 682 |
| COMPLETED | 682 |
| NOT COMPLETED | 0 |
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 | All Participants |
|---|---|---|
| Participants analysed | 682 | |
| Age, Continuous | years | 53.57 (SD 13.86) |
| Sex: Female, Male: Female | Participants | 297 |
| Sex: Female, Male: Male | Participants | 385 |
| Region of Enrollment: Korea, Republic Of | participants | 682 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants Experiencing Adverse Events (AEs), measured over Complete study duration & 30 days after completion (up to approximately 7.5 months).
| 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 experiencing adverse events. It is a participant-level count: the reported figures indicate how many people had an event, rather than how many separate event episodes occurred. The registry defines an adverse event as an unfavorable and unintended sign, symptom, or disease temporally associated with use, whether or not considered related to the medicinal product. The wording in that definition refers to use of a vaccine, even though the study concerns temozolomide; the registry record does not explain this wording.
The observation window is the complete study duration and 30 days after completion, up to approximately 7.5 months. This endpoint is relevant to a postmarketing safety surveillance objective because it captures events observed during use under actual conditions, including events not necessarily judged related to the product. The record also describes an interest in unexpected reactions, misuse, abuse, drug interactions, and other safety information.
A participant count is descriptive. On its own, it does not show how often events occurred per unit of treatment exposure, establish that treatment caused an event, or compare risk with an alternative. The registry record does not provide the event-level detail or analysis needed to answer those separate questions.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted primary result reports 103 participants with serious adverse events among 682 at risk and 132 participants with other adverse events among 682 at risk. These are counts of participants, not counts of all event episodes. The registry also lists serious-event terms and percentages: disease progression, 2.5%; pneumonia, 1.6%; convulsion, 1.3%; pyrexia, 1.0%; neoplasm recurrence, 0.7%; and headache, 0.7%. The record does not give further details about how these term-specific percentages were derived.
These results describe events recorded in the surveillance group over the stated follow-up window. They do not indicate, by themselves, whether an event was caused by temozolomide or radiotherapy. The registry’s adverse-event definition includes events whether or not they were considered related to the medicinal product. The posted figures also do not provide a comparison with an untreated group or another treatment group. As the record states that the study is not a randomized comparison and reports no separate comparator, treatment effects cannot be inferred from these counts.
The event counts should not be read as a complete account of clinical benefit and harm. The surveillance purpose mentions safety and efficacy, but the posted primary outcome is an adverse-event count, and no efficacy result is included in the available record details. The registry lists five outcome measures, while no statistical analyses are listed. No confidence intervals, hypothesis tests, adjusted estimates, or subgroup results are reported in the registry record.
Precision is therefore limited to the descriptive information posted: the number of participants at risk, the number reported with serious and other adverse events, and the listed serious-event terms with their percentages. Without interval estimates or event-level data, the uncertainty around these results cannot be assessed from the record. The counts also do not indicate how many events each participant experienced or whether serious and other event groups overlap.
Overall, the results characterize reported adverse events among participants in this postmarketing surveillance study. They are not a randomized estimate of comparative safety and do not establish causation. The record’s stated aim of examining actual-use safety and efficacy should be distinguished from the narrower scope of the posted primary result: a count of participants experiencing adverse events.
9. Statistical Methods Explained
The posted primary measure is a binary participant-level outcome: each participant either experienced an adverse event during the defined period or did not. The reported result is a count of participants with events. This is different from counting every event episode, because one participant could experience more than one event while still contributing only once to a participant-level count. The registry does not report episode counts or explain how repeated events were handled in the posted summaries.
What does a participant count describe?
A count describes the number of people recorded with an outcome in the group being followed. It is useful for communicating the observed burden in that group, especially when the number at risk is also reported. In this study, the adverse-event results include 682 participants at risk for each reported category. The counts do not, on their own, describe the timing of events, the number of episodes, or differences between treatment strategies.
General statistical context: a proportion can express a participant count relative to the number at risk, while a rate can account for exposure time. The posted information does not provide a rate analysis or participant-level exposure time. No new proportion or rate is calculated. The primary endpoint is not a time-to-event measure, and no time-to-event analysis is reported in the registry record.
What can an uncertainty interval tell a reader?
General statistical context: a confidence interval gives a range of values compatible with the data and a specified statistical procedure. It can show how precisely an estimate has been measured; it does not remove design limitations or establish causation. No confidence interval for the adverse-event counts is reported in the registry record. Consequently, the precision of an estimated event frequency cannot be assessed using an interval from the posted results.
The record lists no statistical analyses. It therefore does not report a model, an adjustment strategy, a hypothesis test, or a method for estimating uncertainty. The sample-size assumptions described for planning illustrations use a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation, with the effect to detect defined as a fraction of the observed effect. These are planning assumptions, not evidence that the study used that design or analysis. The record does not report the numerical outputs of those illustrations in the registry record, and such illustrations are not observed power.
Why does the comparison structure matter?
General statistical context: a randomized comparison can help balance measured and unmeasured factors between groups, while a nonrandomized single-group description cannot isolate the effect of treatment from other influences. This registry record describes one group of all participants and says the study is not a randomized comparison; allocation is not stated. It does not report a like-for-like control group. Differences in participant condition and treatment circumstances are described within the group, but no comparative analysis is posted. The results should therefore be read descriptively rather than as a treatment-effect estimate.
How should serious-event terms be read?
The registry lists six serious-event terms with percentages, alongside the count of participants with serious adverse events. Those term-specific values identify events as classified in the record; they do not explain the denominator, whether terms can occur in the same participant, or whether the event was considered treatment-related. The record also does not provide a detailed coding dictionary or adjudication method. General statistical context: event categories can overlap, and a person may have multiple clinical events, so term counts or percentages should not automatically be added or treated as mutually exclusive categories.
Over-dispersion is relevant in some count models when variation in event counts exceeds what a basic count distribution assumes. General statistical context: it matters when analyzing numbers of events, since an unsuitable variance model can make uncertainty estimates misleading. The posted primary result is a participant count rather than a modeled series of event episodes, and the registry reports no count model or over-dispersion assessment. It would not be appropriate to infer that such a method was used.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists five outcome measures and no statistical analyses. It does not report which outcomes, if any, were treated as confirmatory, how multiple outcomes were handled, or whether any adjustment for multiple testing was planned. When several outcomes are tested, general statistical context is that the chance of at least one false-positive finding can increase if each is assessed separately without an appropriate plan. That concern cannot be quantified for this study from the posted record.
Missing-data methods are not reported in the registry record. The available adverse-event results state that 682 participants were at risk in each category, but the record does not describe completeness of follow-up, withdrawals, missing outcome information, or any imputation approach. It is therefore not possible to determine how incomplete observations were handled or whether participants with incomplete follow-up were included in a particular analysis population.
The record does not define analysis populations beyond the group called All Participants. It does not state whether the primary outcome was analyzed in all enrolled participants, in participants with available follow-up, or according to another rule. Details about exclusions, protocol deviations, or subgroup analysis populations are also not reported in the registry record. These omissions limit assessment of how representative the posted counts are of all enrolled participants and how the other listed outcomes were analyzed.
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 |
|---|---|---|---|
| All Participants | 103 | 682 | 15.1% |
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 |
|---|---|
| All Participants | 132 of 682 |
Most frequent serious adverse event terms
| Event term | Organ system | All Participants |
|---|---|---|
| DISEASE PROGRESSION | General disorders | 17 of 682 |
| PNEUMONIA | Respiratory, thoracic and mediastinal disorders | 11 of 682 |
| CONVULSION | Nervous system disorders | 9 of 682 |
| PYREXIA | General disorders | 7 of 682 |
| NEOPLASM RECURRENCE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 5 of 682 |
| HEADACHE | Nervous system disorders | 5 of 682 |
| HYDROCEPHALUS | Nervous system disorders | 5 of 682 |
| NEUTROPENIA | Blood and lymphatic system disorders | 4 of 682 |
| ALANINE AMINOTRANSFERASE INCREASED | Investigations | 4 of 682 |
| ASPARTATE AMINOTRANSFERASE INCREASED | Investigations | 4 of 682 |
Most frequent non-serious adverse event terms
| Event term | Organ system | All Participants |
|---|---|---|
| NAUSEA | Gastrointestinal disorders | 82 of 682 |
| VOMITING | Gastrointestinal disorders | 54 of 682 |
| DECREASED APPETITE | Metabolism and nutrition disorders | 46 of 682 |
Serious events with the highest arm-level rate: disease progression (2.5%), pneumonia (1.6%), convulsion (1.3%), pyrexia (1.0%), neoplasm recurrence (0.7%).
The registry reports serious adverse events for 103 of the 682 participants at risk, and other adverse events for 132 of the 682 participants at risk. These figures are participant counts. They should not be interpreted as counts of every event episode, and the record does not state whether a participant could appear in both categories. It also does not report event-level detail that would clarify recurrence or timing.
The listed serious-event terms are disease progression at 2.5%, pneumonia at 1.6%, convulsion at 1.3%, pyrexia at 1.0%, neoplasm recurrence at 0.7%, and headache at 0.7%. The registry record does not specify the denominator or method used for these term-specific percentages. The terms should be understood as reported classifications, not as proof that treatment caused those events. The record’s adverse-event definition includes events whether or not considered related to the medicinal product.
No deaths are reported in the available result details. The registry record does not provide a death count in the posted fields. Nor does it report a comparator group that would allow these safety counts to be interpreted relative to another treatment. The figures describe reported safety outcomes in this surveillance group over the stated observation window, up to approximately 7.5 months.
12. What the Result Does, and Does Not, Mean
The results provide a descriptive account of adverse events recorded among 682 participants in a postmarketing surveillance study. The registry reports counts for participants with serious and other adverse events, and percentages for several serious-event terms. These observations address a safety-surveillance objective under actual conditions of use, but they do not establish that treatment caused any particular event.
The study record describes different clinical circumstances and treatment combinations within the All Participants group. Newly diagnosed glioblastoma multiforme participants were described as receiving temozolomide with radiotherapy, while participants with recurrent or progressive malignant glioma after standard therapy were described as receiving temozolomide. Because the record does not report a randomized comparator or a like-for-like control group, the observed counts cannot be used to estimate how event frequency would differ under another treatment or no treatment.
The record’s broader purpose includes assessing efficacy, but the primary result is an adverse-event count. No efficacy findings are reported in the available record details. The safety counts also do not establish a complete benefit-harm profile: event severity, timing, relationship to treatment, and exposure duration by participant are not fully described.
These data therefore support a limited conclusion about what the registry recorded in this group during the stated follow-up period. They do not show comparative treatment effectiveness, identify causal effects, or quantify uncertainty with confidence intervals or other inferential results. The distinction between surveillance description and controlled treatment comparison is central to interpreting what the study can establish.
13. Why This Trial Matters Statistically
Postmarketing surveillance addresses questions that arise when a product is used in clinical practice, including events that may not be fully characterized in earlier studies. This record states that its purpose was to examine safety and efficacy under actual conditions of use and to assess serious and nonserious adverse events, unexpected reactions, events associated with misuse, abuse, or interactions, and other safety or efficacy information. That objective is distinct from testing a treatment effect in a randomized comparison.
Statistically, the record illustrates why the design and the outcome must be considered together. A participant-level adverse-event count can describe the number of people recorded with events, but it cannot by itself separate treatment effects from underlying disease, treatment combinations, or other influences. The group includes participants with different disease circumstances, and radiotherapy is described for some participants. No comparator group or randomized allocation is reported.
The record also illustrates the importance of transparent analysis reporting. Although five outcome measures are listed, no statistical analyses are listed. The registry does not report uncertainty intervals, missing-data methods, analysis populations, or an approach to multiplicity. Without those details, readers can describe the posted counts but cannot assess inferential precision or the handling of other outcomes.
The study is therefore statistically informative as a record of surveillance reporting and its limits. Its counts can be read as observations in the enrolled group, while causal, comparative, and efficacy questions remain unanswered by the posted 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 registry record provides limited information about the study procedures and the participants. Beyond the disease descriptions in the arm, additional eligibility criteria and baseline characteristics are not reported. Dosing, treatment schedules, adherence, duration of exposure, and the details of follow-up are also not reported. These omissions make it difficult to assess how the enrolled group and its exposure experience relate to the observed event counts.
The adverse-event definition includes events whether or not considered related to the medicinal product, but the record does not provide event-level causality assessments, timing, duration, severity breakdowns, or methods for adjudication. The definition refers to use of a vaccine, and the record does not explain that wording in the context of this temozolomide study. The denominator and calculation method for the listed serious-event term percentages are not reported in the registry record.
The results describe one group and do not include a randomized control comparison. No statistical analyses are listed, and the record does not report confidence intervals, hypothesis tests, missing-data handling, analysis populations, or multiplicity procedures. No efficacy result is included in the available details despite the broader surveillance purpose mentioning efficacy. The record also does not provide further results for the other listed outcome measures in the registry record for this account. Together, these limitations restrict interpretation to a descriptive account of the posted adverse-event findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Temodal (Temozolomide) Post Marketing Surveillance Protocol (Study P05557AM2) — NCT00723827.
- Registry record last updated 2015-01-30; status last verified 2015-01.
- Results first posted 2013-01-08.
- 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.
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18. Record Summary
NCT00723827, titled Temodal (Temozolomide) Post Marketing Surveillance Protocol, is listed as completed and sponsored by Merck Sharp & Dohme LLC. The record gives a start date of 2008-03, primary completion in 2011-09, and enrollment of 682 participants. It describes surveillance of temozolomide under actual conditions of use, with radiotherapy included in the treatment description for participants with newly diagnosed glioblastoma multiforme.
The primary outcome counts participants experiencing adverse events during the complete study duration and for 30 days after completion, up to approximately 7.5 months. The posted results report 103 participants with serious adverse events and 132 with other adverse events among 682 at risk in each category. The registry describes the study as not a randomized comparison, reports no separate control group, and lists no statistical analyses. The findings are descriptive and do not establish comparative or causal treatment effects.