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 Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE) (NCT02316613), a registered phase not stated study. The primary outcome is Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02316613 |
| Phase | Phase not stated |
| Condition | Follicular Lymphoma |
| Allocation | Not Stated |
| Design model | Not Stated |
| Masking | Not Stated |
| Enrollment | 260 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Hoffmann-La Roche |
| Results posted | Yes |
2. Clinical Question
Population
The registry describes patients with histologically confirmed, CD20-positive follicular non-Hodgkin lymphoma that was relapsed or refractory. The primary analysis population is narrower: participants with at least one disease progression over the study period, excluding duplicate cases and participants without available data, who met the inclusion and exclusion criteria.
Intervention
This was not a trial assigning a treatment. The study observed real-life therapeutic management, including whether participants received rituximab maintenance. Rituximab is listed as a drug intervention in the registry, but treatment was not allocated by the study.
Comparator
There is no randomized comparator. The study planned to describe the cohort overall and according to the presence or absence of MabThera (rituximab) maintenance therapy. These groups should not be treated as equivalent comparison arms because treatment selection was observational.
Primary question
Among participants with a disease progression, what percentage had each recorded modality of therapeutic decision at the first study progression? The listed modalities are a multidisciplinary consultation meeting, the physician in charge alone, discussion between physicians, or a punctual consultation with an external physician.
The central question is descriptive: how decisions were made in clinical practice after progression, rather than whether one assigned treatment caused better outcomes than another. The registry also lists outcomes concerning treatment response, subsequent progressions, progression-free survival, time to next treatment, overall survival, and MabThera use and regimen. These outcomes can add context about the cohort and its management, but the record does not report numerical results for them in the registry entries.
3. Trial Design
OLYMPE is identified as a prospective, longitudinal, observational cohort study concerning the management of relapsed or refractory follicular lymphoma. It is described as French and multicenter, with actively participating physicians enrolling patients and collecting therapeutic-management information in a real-life setting. The registry lists Hoffmann-La Roche as the sponsor, an enrollment of 260, a start date of 2007-02, primary completion in 2013-04, and a completed status.
Because the study is observational, clinicians—not a study allocation process—determined care. The registry describes evaluation of the cohort overall and according to the presence or absence of MabThera (rituximab) maintenance therapy. This creates groups defined by observed care, not randomized treatment arms. Differences between such groups could reflect patient characteristics, disease history, physician decisions, or other factors as well as treatment. The registry record does not report a randomized allocation process or a like-for-like control comparison.
The primary outcome concerns the modality of the therapeutic decision at the first study disease progression. Its analysis population is described as participants with at least one progression over the study period who met the eligibility criteria, with duplicate cases and participants without available data excluded. The primary outcome timeframe is listed as up to 6 years. Separately, the brief summary describes data collection up to 5 years. The registry record does not explain the difference between those stated timeframes.
The listed participant description includes histologically confirmed, CD20-positive relapsed or refractory follicular non-Hodgkin lymphoma and states that first-line treatment could vary. The eligibility wording in the arm description ends with “and eligible”; the full criteria are not reported in the registry record. The record also lists rituximab as a drug intervention, while the study’s overall purpose is to describe treatment modalities rather than test a prescribed regimen.
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: Of 260 participants, 5 were excluded as no data available and duplicate cases (N=255; safety population) and 14 were excluded as other selection criteria not met (N=241; overall population).
Overall Study
| Stage | All Participants |
|---|---|
| STARTED | 260 |
| Safety Population | 255 |
| Overall Population | 241 |
| COMPLETED | 156 |
| NOT COMPLETED | 104 |
Reasons for not completing this period:
| Reason | All Participants |
|---|---|
| Death | 63 |
| Lost to Follow-up | 9 |
| Lymphoma transformation | 2 |
| Participant moved/changed medical team | 11 |
| No data and duplicate cases | 5 |
| Did not met selection criteria | 14 |
Analysis population for the primary outcome, as defined in the registry: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included. Number of participants analyzed = participants who were evaluable for this outcome measure.
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: Overall population: All the participants (except duplicate cases and participants without data available) meeting all the inclusion/exclusion criteria were included.
| Characteristic | Unit | All Participants |
|---|---|---|
| Participants analysed | 241 | |
| Age, Continuous | years | 61.6 (SD 11.2) |
| Sex: Female, Male: Female | Participants | 110 |
| Sex: Female, Male: Male | Participants | 131 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Modalities of the Therapeutic Decision at First Study Disease Progression, measured over Up to 6 years.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | percentage of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants in each recorded category of therapeutic decision at the first study disease progression. The categories distinguish a decision made through a multidisciplinary consultation meeting, by the physician in charge alone, through discussion between physicians, or after a punctual consultation with an external physician. The endpoint therefore describes the process by which management decisions were reached, not the clinical effectiveness of any particular treatment.
The stated analysis population consists of eligible participants who experienced at least one disease progression during the study period. Duplicate cases and participants without data available are excluded. The registry defines the reported quantity as a percentage of participants, but the actual category percentages and their denominators are not reported in the registry record. The timeframe is listed as up to 6 years.
A descriptive endpoint of this kind is useful for characterizing care in routine practice. It can show how decision-making was organized among the observed participants and provide context for the treatment patterns recorded in the cohort. It does not, by itself, establish that one decision-making modality leads to better outcomes. Participants were not randomized to a decision process, and the registry record does not report an adjusted comparison or a causal analysis linking decision modality to subsequent health outcomes.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record identifies the primary outcome and its intended analysis population, but numerical results for that outcome are not reported in the registry record. Consequently, it is not possible to describe which decision modality was most common, how the categories differed, or how precisely any percentage was estimated. No confidence intervals or p-values for the primary outcome are reported in the registry record. The record lists 0 analyses, so there is no sponsor analysis result to interpret from the stated details.
The outcome is a description of decision-making practice among eligible participants who had at least one progression. It is not a treatment effect. A higher percentage in a decision category, if reported, would indicate that the category was recorded more often in the analyzed cohort; it would not establish that the approach improved disease control, survival, or quality of care. The observational design also means any comparison by maintenance treatment would be vulnerable to differences in who received that treatment and why.
The registry lists several additional outcomes, including last induction treatment response, number of disease progressions, disease characteristics at first progression, progression-free survival, time to next treatment, overall survival, and MabThera use and dose. Their inclusion indicates the range of topics the study intended to describe. Numerical results for these outcomes are not reported in the registry record in the registry record for interpretation, so no event rates, time-to-event estimates, treatment patterns, or associations can be stated.
Safety information is listed for an “All Participants” group. The serious-event figures state 243 at risk and 94 affected; the other adverse-event figures state 243 at risk and 134 affected. The record also lists serious-event terms with percentages, including lung infection at 6.2% and pyrexia at 2.9%. These figures describe recorded events in the cohort; they do not establish that a particular treatment caused them. The registry record does not report the definitions, follow-up completeness, or denominators underlying the listed term percentages in the registry record.
The completed status and enrollment of 260 describe the registry record’s study-level information, not the denominator for every outcome. For the primary outcome, the analysis population is specifically participants with progression and available data, subject to eligibility and duplicate-case exclusions. Those distinctions matter: enrollment should not be substituted for an outcome-specific denominator. The actual denominator and category counts for the primary outcome are not reported in the registry record.
Overall, the record supports a cautious interpretation of OLYMPE as an observational description of management in a real-life cohort. It does not supply enough result information to assess the distribution of the primary endpoint or the precision of estimates, and it does not support causal claims about rituximab maintenance or any decision modality.
9. Statistical Methods Explained
OLYMPE is described as a prospective observational study. In general, a prospective cohort follows people forward from enrollment while recording exposures, care, and outcomes as they occur. That approach can characterize practice over time, but it does not create randomized treatment groups. Because the clinicians chose care, observed differences between treatment groups may reflect patient or disease features that influenced those choices. The registry record does not report a statistical plan that would resolve such confounding.
What does a percentage endpoint describe?
The primary endpoint is a percentage of participants assigned to each recorded decision-making category at first study progression. In general, a percentage summarizes the share of an analysis population with a particular recorded outcome. Interpretation depends on the numerator definition and the denominator. The registry identifies the analysis population as eligible participants with at least one progression, excluding duplicate cases and participants without available data. It does not report the category counts, actual denominator, or percentages in the registry record for interpretation. Those values therefore cannot be used to assess the distribution or precision of the endpoint.
For a percentage estimate, a confidence interval would describe the statistical uncertainty associated with the estimate under the method used. A narrow interval generally indicates greater precision than a wide interval, while neither interval width nor the estimate alone resolves systematic bias. No confidence interval or method for calculating one is reported in the registry record. Without the endpoint estimate and its uncertainty, the size and precision of any difference among the decision categories cannot be assessed.
What can an observational comparison establish?
In general, observational group comparisons describe associations in the recorded data. They do not automatically isolate a treatment effect, because treatment choice may depend on factors that also relate to outcomes. In OLYMPE, the cohort was evaluated overall and according to the presence or absence of MabThera maintenance, but assignment was not randomized. The registry record does not report whether the groups were adjusted for measured characteristics, which adjustment variables would have been used, or whether any causal analysis was planned. It is therefore not appropriate to read the maintenance groups as if they were interchangeable trial arms.
The registry lists progression-free survival, time to next treatment, and overall survival among the secondary outcomes. In general, time-to-event analyses account for the time until an event and may also need to handle participants whose event status is not observed for the full follow-up period. The registry record does not report the event definitions in detail, censoring rules, analytic methods, estimates, or uncertainty for these outcomes. No survival curve or hazard estimate can be interpreted in the registry record.
What does over-dispersion mean in general?
For count outcomes, a simple statistical model may assume that variability follows a particular distribution. Over-dispersion occurs when the observed variation is greater than that model allows; ignoring it can make uncertainty appear too small. This is a general consideration for count data, not a reported feature or method of OLYMPE. The record lists outcomes involving numbers of disease progressions but does not state the model used, whether over-dispersion was assessed, or how uncertainty was estimated.
The registry’s sample-size assumptions describe a planning illustration based on an observed effect, with a two-sided significance level of 0.05, equal allocation, and a normal approximation. The effect to detect is expressed as a stated fraction of the observed effect. In general, such illustrations show how a hypothetical future study’s required sample size might vary under specified assumptions; they are not observed power and do not change the observational study design. The record does not provide a sample-size justification for OLYMPE itself, and the illustration is not evidence that the cohort was planned or powered for the primary endpoint.
For time-to-event planning illustrations, the stated method uses the total number of events; for other illustrations, the reported unit is participants per arm. These are planning conventions, not observed outcomes. No numerical planning results are reported in the registry record for interpretation, so no sample-size figure can be stated. The registry record also does not report interim analyses, a prespecified statistical analysis plan, or the methods used to produce the posted results.
How should uncertainty and significance be read?
In general, a p-value measures how incompatible data are with a specified statistical model and null hypothesis, assuming the model and analysis conditions hold. It does not measure the probability that a treatment works, nor does it establish clinical importance. Confidence intervals communicate a range of estimates compatible with the data and method, while also requiring attention to design and bias. For OLYMPE, no primary-outcome p-value or confidence interval is reported in the registry record, and the listed analysis count is 0. Statistical significance and precision therefore cannot be evaluated for the primary endpoint.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists 24 outcome measures, spanning treatment decisions, disease progression, survival, and MabThera use and regimen. When many outcomes are examined, the chance of finding at least one apparently notable result can increase. In general, multiplicity procedures may control the interpretation of multiple tests, or an analysis plan may identify a primary outcome and distinguish confirmatory from exploratory outcomes. The registry record does not report a multiplicity adjustment, hierarchy among the outcomes beyond the stated primary outcome, or a prespecified analysis plan. No significance claims across outcomes can therefore be assessed from the record.
The primary analysis population excludes duplicate cases and participants without available data and is limited to eligible participants with at least one disease progression. This is an outcome-specific population; the enrollment of 260 should not be assumed to be the denominator for the primary percentage. The actual number analyzed and the number in each decision category are not reported in the registry record.
In general, missing data can affect an estimate if participants with missing information differ systematically from those with observed information. The record specifies exclusion of participants without data available for the primary outcome, but it does not report how much data were missing, why data were unavailable, or whether any imputation or sensitivity analysis was used. Handling of missing information for the secondary outcomes is not reported in the registry record.
The registry lists 0 analyses. It does not report interim analyses, analysis populations for the secondary outcomes, or a statistical plan describing model selection, covariate adjustment, or multiplicity handling. These omissions limit assessment of how the reported outcomes were selected and 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 | 94 | 243 | 38.7% |
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 | 134 of 243 |
Most frequent serious adverse event terms
| Event term | Organ system | All Participants |
|---|---|---|
| Lung infection | Infections and infestations | 15 of 243 |
| Pyrexia | General disorders | 7 of 243 |
| Disease progression | General disorders | 6 of 243 |
| Urinary tract infection | Infections and infestations | 5 of 243 |
| Neutropenia | Blood and lymphatic system disorders | 5 of 243 |
| Bacteraemia | Infections and infestations | 4 of 243 |
| Acute myeloid leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 4 of 243 |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 4 of 243 |
| Anaemia | Blood and lymphatic system disorders | 4 of 243 |
| Thrombocytopenia | Blood and lymphatic system disorders | 4 of 243 |
Most frequent non-serious adverse event terms
| Event term | Organ system | All Participants |
|---|---|---|
| Pyrexia | General disorders | 49 of 243 |
| Bronchitis | Infections and infestations | 47 of 243 |
| Herpes zoster | Infections and infestations | 14 of 243 |
| Pharyngitis | Infections and infestations | 12 of 243 |
| Sinusitis | Infections and infestations | 12 of 243 |
Serious events with the highest arm-level rate: lung infection (6.2%), pyrexia (2.9%), disease progression (2.5%), urinary tract infection (2.1%), neutropenia (2.1%).
The registry’s “All Participants” safety group reports 243 participants at risk and 94 affected for serious events. For the other adverse-event figures, it reports 243 at risk and 134 affected. These are separate recorded quantities; they should not be combined or converted into a new rate without the registry’s definitions and analysis details. Deaths are not reported in the registry record.
The listed serious-event terms and percentages are lung infection, 6.2%; pyrexia, 2.9%; disease progression, 2.5%; urinary tract infection, 2.1%; neutropenia, 2.1%; and bacteraemia, 1.6%. These are the recorded term-specific figures, not evidence on their own that a drug caused the events. The registry record does not report the denominator or detailed coding and attribution rules for these percentages in the registry record for interpretation.
Safety interpretation also depends on observation duration and completeness, event definitions, and whether events are counted by participant or occurrence. Those details are not reported in the registry record. As an observational cohort, OLYMPE records events in the context of real-life care; the listed counts and terms should not be interpreted as a randomized comparison of treatment safety.
12. What the Result Does, and Does Not, Mean
OLYMPE addresses a practical descriptive question: how therapeutic decisions were made at the first study progression among eligible participants with relapsed or refractory follicular lymphoma. The registry identifies the decision categories and the population intended for analysis. It also records the study as a prospective, longitudinal, observational cohort intended to describe treatment modalities in real-life care.
The information does not establish which decision modality was most frequent, because the primary category percentages and counts are not reported in the registry record. It also does not establish whether any modality was associated with better outcomes. There is no randomized assignment to decision processes or treatments, and the registry entries available do not report adjusted estimates or a causal analysis. The maintenance-therapy groups are observational, not equivalent control arms.
The listed secondary outcomes indicate that the study covered treatment response, disease progression, progression-free survival, time to next treatment, overall survival, and MabThera use and dose. Their numerical results are not reported in the registry record in the registry record for interpretation. The safety record contains event counts and term-specific percentages, but without details on definitions, attribution, follow-up, or term denominators, these values cannot support a comparative safety conclusion.
The enrollment of 260 and completed status provide context about the registry study, but enrollment is not the same as the analysis population for every outcome. For the primary endpoint, the record specifies an eligible population with at least one progression and excludes duplicate cases and participants without available data. The actual analyzed denominator is not reported.
Accordingly, the strongest supported reading is that OLYMPE was designed to document real-world management and outcomes in this cohort. The record does not provide the numerical primary result or enough statistical detail to judge its precision, compare decision approaches, or make causal claims about rituximab maintenance.
13. Why This Trial Matters Statistically
Observational cohorts can answer questions about how care is delivered outside a randomized assignment process. OLYMPE is relevant in that respect: it was designed to document treatment modalities and follow participants with relapsed or refractory follicular lymphoma in a real-life setting. Its primary endpoint focuses not on a drug effect but on the clinical decision process at first study progression.
That focus is statistically important because decision-making itself can shape the treatment patterns and outcomes later observed. Describing whether decisions involved a multidisciplinary meeting, the physician in charge, discussion among physicians, or an external consultation can help characterize practice. The endpoint can therefore provide context for interpreting subsequent care, if its category results are available.
The design also illustrates the distinction between cohort description and causal comparison. A comparison by rituximab maintenance status may be informative about observed practice, but treatment selection was not randomized. Differences between groups can reflect clinical selection and other factors, so an observed contrast would not by itself identify a treatment effect. The registry record does not report methods that would quantify or address those sources of bias.
Finally, the record lists multiple disease, survival, treatment, and safety outcomes, while reporting 0 analyses in the registry record. That gap matters for statistical interpretation: an outcome’s presence in a registry entry is not the same as a reported estimate with a defined analysis population and uncertainty. The study’s intended scope is clear, but its primary numerical findings and inferential detail are not reported in the registry record.
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 primary limitation for interpretation is that the numerical result for the primary endpoint is not reported in the registry record. The decision-category counts, percentages, analyzed denominator, and confidence intervals are also not reported. Without them, the frequency and precision of each decision modality cannot be assessed.
The study is observational, and treatment was not assigned at random. Any contrast according to rituximab maintenance status could be influenced by differences in patients, disease course, or clinical decisions. The registry record does not report an adjusted analysis or the covariates that might have been considered. It therefore does not support a causal interpretation of group differences.
The record lists 24 outcome measures but does not describe a statistical analysis plan, multiplicity handling, interim analyses, or analysis populations for the secondary outcomes. It lists 0 analyses, and numerical results for the listed secondary outcomes are not reported in the registry record for interpretation. Missing-data amounts, reasons, and handling beyond the stated primary-population exclusion are not reported.
The brief summary describes collection up to 5 years, whereas the primary outcome timeframe is listed as up to 6 years. The registry record does not explain this difference. The arm description also ends with “and eligible,” and the complete inclusion and exclusion criteria are not reported in the registry record. These gaps limit assessment of follow-up and eligibility.
Safety interpretation is constrained by absent event definitions, term-specific denominators, attribution rules, and details on follow-up completeness. The reported event figures should be read as registry descriptions, not as estimates of comparative treatment risk.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Prospective Observational Study on the Management of Patients With Relapsed or Refractory Follicular Lymphoma (OLYMPE) — NCT02316613.
- Registry record last updated 2016-02-25; status last verified 2016-01.
- Results first posted 2016-02-25.
- 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
OLYMPE is a completed French, multicenter, prospective observational cohort study sponsored by Hoffmann-La Roche. The registry lists enrollment of 260, a start date of 2007-02, and primary completion in 2013-04. It concerns the management of patients with relapsed or refractory follicular lymphoma and describes real-life treatment patterns, including evaluation according to the presence or absence of MabThera (rituximab) maintenance.
The primary outcome is the percentage of participants in each therapeutic-decision modality at first study progression, with a timeframe of up to 6 years. Its analysis population excludes duplicate cases and participants without available data and includes eligible participants with at least one progression. The category results and actual denominator are not reported in the registry record. The record lists 24 outcome measures and 0 analyses. Safety figures include 243 at risk and 94 affected for serious events, and 243 at risk and 134 affected for other adverse events. Overall, the registry describes a cohort and its intended outcomes but does not report the numerical primary result or enough analysis detail for causal or precision claims.