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 Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). (NCT01682083), a randomized phase 3 study. The primary outcome is Percentage of Participants With Relapse-free Survival (RFS) Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01682083 |
| Phase | Phase 3 |
| Condition | Melanoma |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Double |
| Enrollment | 870 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Novartis Pharmaceuticals |
| Results posted | Yes |
2. Clinical Question
Population
Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk cutaneous melanoma were screened. The listed stages were Stage IIIa with lymph node metastasis >1 mm, Stage IIIb, and Stage IIIc. The primary outcome population is identified as the Intent-to-Treat (ITT) Population.
Intervention
The active-treatment group received dabrafenib, 150 mg twice daily, with trametinib, 2 mg once daily, orally for 12 months. Treatment could end earlier under the stated conditions of recurrence, death, unacceptable toxicity, or withdrawal of consent; dose modification or interruption was permitted for toxicity management.
Comparator
The control group received matching placebos for dabrafenib and trametinib orally for 12 months. The trial was randomized and double-blind, and the registry record states that crossover was not permitted.
Primary question
The primary outcome was the percentage of participants with relapse-free survival events, assessed over approximately 4 years. RFS was defined as time from randomization to disease recurrence or death from any cause. The registry record defines the outcome but does not report the event counts or a treatment comparison for it, so the primary question cannot be answered from the results recorded.
3. Trial Design
COMBI-AD was a Phase III randomized, double-blind, parallel-group study sponsored by Novartis Pharmaceuticals. The registry lists enrollment of 870. The study description says approximately 852 patients were planned for randomization in a 1:1 ratio. These are different figures: enrollment is the recorded trial figure, while the approximate figure is the stated plan.
Participants were assigned to dabrafenib plus trametinib or matching placebos following surgical resection. Randomization was stratified by BRAF mutation status, V600E or V600K, and disease stage, Stage IIIa, IIIb, or IIIc. Treatment was planned for 12 months, subject to recurrence, death, unacceptable toxicity, or withdrawal of consent. Dose modifications and interruptions were allowed for toxicity management. Follow-up for recurrence and survival continued during and after the treatment period, and crossover was not permitted.
The registry records the study start as 2013-01-08 and primary completion as 2017-06-30, with status listed as completed. The primary outcome timeframe is approximately 4 years. The detailed timing and conduct of other analyses are not reported in the registry record.
The enrolled study population and the planned randomization figure should not be treated as interchangeable. Nor does the randomization plan alone establish that the groups were identical in every baseline characteristic. The registry describes the intended allocation and stratification factors, but baseline results are not reported in the registry record. The key design feature for interpreting the primary comparison is the randomized, double-blind allocation between combination therapy and matching placebos in the specified post-resection population.
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: Patients were planned to be randomized in a 1:1 ratio, stratified by BRAF mutation status (V600E, V600K) and stage of disease (Stage IIIa, IIIb, IIIc).
Overall Study
| Stage | Dabrafenib and Trametinib Combination Therapy | Dabrafenib and Trametinib Placebos |
|---|---|---|
| STARTED | 438 | 432 |
| Untreated | 3 | 0 |
| Safety Population | 435 | 432 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 438 | 432 |
Reasons for not completing this period:
| Reason | Dabrafenib and Trametinib Combination Therapy | Dabrafenib and Trametinib Placebos |
|---|---|---|
| Death | 125 | 136 |
| Study closed by sponsor | 225 | 192 |
| Lost to Follow-up | 27 | 43 |
| Physician Decision | 11 | 8 |
| Withdrawal by Subject | 50 | 53 |
Analysis population for the primary outcome, as defined in the registry: Intent-to-Treat (ITT) Population
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Dabrafenib and Trametinib Combination Therapy | Dabrafenib and Trametinib Placebos | Total |
|---|---|---|---|---|
| Participants analysed | 438 | 432 | 870 | |
| Age, Continuous | Years | 50.4 (SD 14.17) | 50.5 (SD 13.14) | 50.4 (SD 13.66) |
| Sex: Female, Male: Female | Participants | 195 | 193 | 388 |
| Sex: Female, Male: Male | Participants | 243 | 239 | 482 |
| Race/Ethnicity, Customized: White | Participants | 432 | 427 | 859 |
| Race/Ethnicity, Customized: Asian | Participants | 6 | 5 | 11 |
6. Primary Endpoint
The registry lists the primary outcome as Percentage of Participants With Relapse-free Survival (RFS) Events, measured over Approximately 4 years.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the percentage of participants with relapse-free survival (RFS) events in the Intent-to-Treat population, assessed over approximately 4 years. RFS is defined from randomization to disease recurrence or death from any cause. The event definition includes loco-regional recurrence, distant metastases, a new primary melanoma, and death without previously documented recurrence. Such deaths count as events rather than being censored.
This endpoint captures more than one type of recurrence and includes death, making it a composite measure of time until a clinically relevant event. General statistical explanation: a time-to-event endpoint can use information about both whether an event occurred and when it occurred. Censoring allows follow-up information to be represented for participants whose event status is not observed through the analysis cutoff, but censored observations are not equivalent to confirmed event-free outcomes for all future time.
At the stated analysis cutoff, 30-Jun-2017, participants without an event were censored at their last radiological or non-radiological efficacy assessment. Participants lost to follow-up before recurrence, or starting subsequent anti-cancer therapy before recurrence, were censored at their last efficacy assessment before loss or treatment initiation. The registry says that events after prolonged loss to follow-up were handled per the analysis plan; the details of that plan are not reported in the registry record.
The outcome definition helps identify what counted as an event, but it does not by itself establish the treatment effect. The registry record does not report the primary event counts or a numerical comparison, so the magnitude and precision of any RFS difference cannot be assessed from this record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The available record establishes the trial’s design and the definition of its primary outcome, but it does not give the primary RFS event counts, an effect estimate, or a confidence interval. The record also indicates that the primary outcome has several categories or time points and is not reduced to one comparison in the posted results. Consequently, no numerical conclusion about the relative RFS outcomes can be drawn from the information recorded.
This distinction matters because a protocol description and an outcome definition are not results. Knowing that recurrence and death counted as events does not reveal how many events occurred in either group, when they occurred, or how the groups compared. Similarly, randomized allocation and double blinding describe the design; they do not substitute for an estimated effect and its uncertainty.
General statistical explanation: an effect estimate expresses the direction and magnitude of a between-group comparison, while a confidence interval describes the range of values compatible with the data and the method used. Without a reported estimate and interval, readers cannot assess the precision of an RFS comparison. A p-value alone, if one were reported, would not provide the size or clinical meaning of an effect; no primary-outcome p-value is reported in the registry record.
The safety record contains counts of participants affected by serious and other adverse events during the listed treatment groups, as well as post-treatment death counts. These are descriptive entries and should be read in their recorded categories. They do not provide an RFS estimate, and they should not be used to infer the benefit-harm balance without the relevant outcome analyses and appropriate context.
The registry lists secondary outcomes involving overall survival, distant metastasis-free survival, and freedom from relapse. Their presence identifies additional outcomes of interest, but the information in this record does not provide their numerical results. A reader should distinguish outcomes named in the registry from outcomes for which results and uncertainty are actually reported.
The enrollment figure and design details also do not answer whether the observed evidence was precise. No reported primary estimate means there is no basis in this record for judging whether any difference was small, large, or statistically uncertain. It is therefore appropriate to describe what was planned and defined, while leaving the treatment comparison unresolved from the registry information presented.
9. Statistical Methods Explained
The registry describes a randomized, double-blind, parallel-group design and identifies the primary endpoint as the percentage of participants with RFS events. It also defines RFS using time from randomization to recurrence or death. However, the registry record does not report the primary-outcome counts, effect estimate, confidence interval, or a single treatment comparison. The statistical interpretation must therefore focus on what the design and endpoint mean, rather than reconstructing an unreported result.
What does randomization contribute?
General statistical explanation: randomization assigns participants to treatment groups using a chance-based process. This is intended to reduce systematic differences between groups at assignment, including differences that are not measured. It does not guarantee that every characteristic is exactly balanced, and it does not eliminate uncertainty due to the finite amount of observed data. The trial description states that allocation was 1:1 and stratified by BRAF mutation status and disease stage. Those are features of the design, not evidence about the eventual balance of characteristics; baseline results are not reported in the registry record.
Double blinding means that knowledge of assigned treatment was masked according to the study design. The registry identifies the study as double-blind and describes matching placebos. Details of who remained masked, how masking was maintained, and whether it was assessed are not reported in the registry record.
How should a time-to-event endpoint be understood?
General statistical explanation: time-to-event analysis uses the time until an event as well as event status. Participants who have not experienced an event by the analysis cutoff may contribute information up to their last assessment, even though their later event status is unknown. Such observations are censored. Censoring is not the same as counting a participant as event-free indefinitely; it marks the point through which outcome information is available.
The RFS definition specifies which outcomes counted: recurrence, new primary melanoma, or death from any cause. Death without previously documented recurrence counted as an event, not as a censored observation. Participants without events at the cutoff were censored at their last efficacy assessment. The registry also describes censoring at the last assessment before loss to follow-up or subsequent anti-cancer therapy when those occurred before recurrence. How events after prolonged loss to follow-up were handled is referred to an analysis plan, but the detailed method is not reported in the registry record.
What can be inferred from the endpoint label?
The registry’s endpoint title refers to the percentage of participants with RFS events, and its parameter is a participant count. The outcome definition itself is time-to-event. Those descriptions do not provide event counts or a comparison estimate. The registry record indicates that the primary outcome has several categories or time points and is not reduced to one comparison in the posted results. A reader should not infer a risk ratio, hazard ratio, median time, or other statistic from the endpoint wording alone; none is reported in the registry record.
What does the sample-size illustration represent?
General statistical explanation: a sample-size calculation is a planning exercise about the amount of information that may be needed under stated assumptions. The record says its planning illustrations use the observed effect, a two-sided significance level of 0.05, equal allocation, and a normal approximation, with the effect to detect expressed as a stated fraction of the observed effect. It specifies that time-to-event illustrations use a total event count based on the Schoenfeld approach, while other illustrations give participants per arm.
These are planning illustrations, not observed power and not a substitute for the trial’s own design justification. The numerical illustration results and the trial’s own sample-size justification are not reported in the registry record. The stated planning assumptions should not be interpreted as evidence that the trial achieved a particular probability of detecting an effect.
Why do estimates need uncertainty measures?
General statistical explanation: an estimate from a trial is subject to sampling variability. A confidence interval communicates the precision of an estimate under its statistical assumptions; a narrower interval indicates greater precision than a wider interval on the same scale. Interpretation depends on both the estimated effect and the interval, not only on whether a significance threshold is crossed. No primary RFS estimate or confidence interval is reported in the registry record, so its precision cannot be assessed.
Over-dispersion is a general concern when count data vary more than an assumed model allows; underestimating that variation can make uncertainty appear too small. The record does not state that an over-dispersion model was used for the RFS analysis, and it does not report the primary statistical model. Therefore, no claim about model choice, variance adjustment, hazard modeling, or standard-error calculation can be made from the registry information available.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists RFS as the primary outcome and names secondary outcomes that include overall survival, distant metastasis-free survival, and freedom from relapse, with event and survival measures among the listed outcomes. The number of outcome measures is recorded as 9, and the number of analyses as 4. These registry counts do not describe how testing across outcomes or analyses was controlled.
Whether the study used a multiplicity adjustment, a hierarchical testing procedure, or another approach to account for multiple comparisons is not reported in the registry record. The significance threshold and testing strategy for the trial’s own primary analysis are also not reported. The planning illustration’s stated two-sided significance level of 0.05 is not evidence of the trial’s complete analysis plan or of how multiple outcomes were handled.
The primary population is identified as the Intent-to-Treat (ITT) Population. The record does not report the analysis populations used for secondary outcomes or explain how participants were handled for any reported treatment comparison. It therefore does not permit an assessment of whether all randomized participants contributed to each analysis.
Some rules for incomplete outcome observation are stated: participants without events at the cutoff were censored at their last efficacy assessment, and specified participants who were lost to follow-up or began subsequent anti-cancer therapy before recurrence were censored at their last efficacy assessment before that event. The handling of events after prolonged loss to follow-up is referred to the analysis plan, whose details are not reported in the registry record. Imputation methods, sensitivity analyses for missing outcome information, and assessments of the assumptions behind censoring are not reported in the registry record.
Censoring rules describe how some incomplete follow-up is represented; they do not establish that missing information has no effect on results. Without the primary estimates, analysis details, and sensitivity analyses, readers cannot evaluate the robustness of an RFS comparison.
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 |
|---|---|---|---|
| Dabrafenib + Trametinib Combination Therapy | 155 | 435 | 35.6% |
| Dabrafenib and Trametinib Placebos | 44 | 432 | 10.2% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Dabrafenib + Trametinib Combination Therapy | 4 of 438 |
| Dabrafenib and Trametinib Placebos | 1 of 432 |
| Dabrafenib + Trametinib Combination Therapy (Post-treatment) | 121 of 431 |
| Dabrafenib and Trametinib Placebos (Post-treatment) | 135 of 431 |
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 |
|---|---|
| Dabrafenib + Trametinib Combination Therapy | 414 of 435 |
| Dabrafenib and Trametinib Placebos | 343 of 432 |
| Dabrafenib + Trametinib Combination Therapy (Post-treatment) | 0 of 0 |
| Dabrafenib and Trametinib Placebos (Post-treatment) | 0 of 0 |
Most frequent serious adverse event terms
| Event term | Organ system | Dabrafenib + Trametinib Combination Therapy | Dabrafenib and Trametinib Placebos | Dabrafenib + Trametinib Combination Therapy (Post-treatment) | Dabrafenib and Trametinib Placebos (Post-treatment) |
|---|---|---|---|---|---|
| Pyrexia | General disorders | 67 of 435 | 4 of 432 | n/a of 0 | n/a of 0 |
| Ejection fraction decreased | Investigations | 13 of 435 | 5 of 432 | n/a of 0 | n/a of 0 |
| Chills | General disorders | 13 of 435 | 0 of 432 | n/a of 0 | n/a of 0 |
| Erysipelas | Infections and infestations | 8 of 435 | 1 of 432 | n/a of 0 | n/a of 0 |
| Cellulitis | Infections and infestations | 5 of 435 | 1 of 432 | n/a of 0 | n/a of 0 |
| Squamous cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 3 of 435 | 3 of 432 | n/a of 0 | n/a of 0 |
| Hypotension | Vascular disorders | 6 of 435 | 0 of 432 | n/a of 0 | n/a of 0 |
| Central serous chorioretinopathy | Eye disorders | 4 of 435 | 0 of 432 | n/a of 0 | n/a of 0 |
| Vomiting | Gastrointestinal disorders | 4 of 435 | 0 of 432 | n/a of 0 | n/a of 0 |
| Sepsis | Infections and infestations | 4 of 435 | 0 of 432 | n/a of 0 | n/a of 0 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Dabrafenib + Trametinib Combination Therapy | Dabrafenib and Trametinib Placebos | Dabrafenib + Trametinib Combination Therapy (Post-treatment) | Dabrafenib and Trametinib Placebos (Post-treatment) |
|---|---|---|---|---|---|
| Fatigue | General disorders | 204 of 435 | 122 of 432 | n/a of 0 | n/a of 0 |
| Pyrexia | General disorders | 248 of 435 | 45 of 432 | n/a of 0 | n/a of 0 |
| Headache | Nervous system disorders | 170 of 435 | 102 of 432 | n/a of 0 | n/a of 0 |
| Nausea | Gastrointestinal disorders | 173 of 435 | 88 of 432 | n/a of 0 | n/a of 0 |
| Diarrhoea | Gastrointestinal disorders | 143 of 435 | 65 of 432 | n/a of 0 | n/a of 0 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 122 of 435 | 68 of 432 | n/a of 0 | n/a of 0 |
| Chills | General disorders | 158 of 435 | 19 of 432 | n/a of 0 | n/a of 0 |
| Rash | Skin and subcutaneous tissue disorders | 112 of 435 | 54 of 432 | n/a of 0 | n/a of 0 |
| Vomiting | Gastrointestinal disorders | 120 of 435 | 43 of 432 | n/a of 0 | n/a of 0 |
| Myalgia | Musculoskeletal and connective tissue disorders | 70 of 435 | 40 of 432 | n/a of 0 | n/a of 0 |
Serious events with the highest arm-level rate: pyrexia (15.4%), chills (3.0%), ejection fraction decreased (3.0%), erysipelas (1.8%), hypotension (1.4%).
The registry records serious adverse events for the on-treatment groups as 155 of 435 participants in the dabrafenib plus trametinib group and 44 of 432 participants in the placebo group. It records other adverse events as 414 of 435 and 343 of 432, respectively. These are counts of participants affected within the listed groups, not event totals; a participant may have experienced more than one event. The registry also records deaths of 4 and 1 in those groups.
The post-treatment entries list 121 deaths for the combination-therapy group and 135 for the placebo group, while the corresponding at-risk figures are 0. These entries should be kept separate from the on-treatment counts. The record does not explain their denominator or provide enough detail to combine or directly compare them with the on-treatment figures.
The listed serious adverse-event terms and percentages are pyrexia, 15.4%; chills, 3.0%; ejection fraction decreased, 3.0%; erysipelas, 1.8%; hypotension, 1.4%; and cellulitis, 1.1%. Corresponding percentages for the placebo group are not reported in the registry record. These listed percentages do not by themselves show the full distribution of serious events or establish a causal relationship. The exposure periods and event-specific details needed for a fuller comparison are not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The registry record establishes that COMBI-AD was a randomized, double-blind Phase III study of dabrafenib plus trametinib compared with matching placebos after resection of high-risk BRAF V600 mutation-positive melanoma. It also specifies the primary endpoint’s event definition and the population in which it was assessed. Those details explain the clinical question and the intended comparison.
They do not establish the primary result. The RFS event counts, a treatment-effect estimate, and its confidence interval are not reported in the registry record. The primary outcome is also not reduced to one comparison in the posted results described by the record. As a result, the size, direction, and precision of the RFS comparison cannot be determined from this information.
The adverse-event entries provide descriptive counts for the listed treatment groups and percentages for several serious adverse-event terms. They are relevant to understanding the safety information recorded, but the absence of corresponding term percentages for the comparator and further details about exposure and follow-up limits direct interpretation. They should not be used alone to draw a conclusion about overall safety or to balance safety against RFS.
General statistical explanation: a trial result is most informative when it includes a clearly defined comparison, an effect estimate, and an uncertainty measure. A numerical difference, if reported, would still need interpretation in light of the endpoint, follow-up, analysis population, missing-data handling, and multiplicity strategy. Those elements are not all available in the registry record.
The record supports statements about the trial design, planned treatment, listed enrollment, endpoint definition, censoring rules, and recorded adverse-event figures. It does not support a conclusion that the active regimen did or did not improve RFS, nor does it quantify the precision of any such comparison. That distinction is important: absence of a reported primary comparison in this record is not itself evidence of no effect.
13. Why This Trial Matters Statistically
COMBI-AD illustrates why trial design and result reporting must be read together. Randomization, double blinding, parallel groups, and matching placebos describe how the comparison was structured. The endpoint definition specifies that relapse-free survival included recurrence and death from any cause, with death without documented recurrence counted as an event. These details are essential for understanding what a reported comparison would mean.
The trial also illustrates the role of censoring in follow-up. Participants who had not experienced an event by the analysis cutoff were censored at their last efficacy assessment, and the record gives rules for certain cases of loss to follow-up or subsequent anti-cancer treatment. Such rules matter because incomplete follow-up changes what is known about event timing. The full handling of prolonged loss to follow-up is not reported in the registry record.
Statistically, however, design information cannot replace an estimate and its uncertainty. Without the RFS event counts and a reported comparison, readers cannot judge the magnitude or precision of the primary result. This makes transparent outcome reporting as important as a well-described design. Naming an endpoint and explaining how it is defined allow readers to assess relevance, but not to reconstruct an unreported effect.
The record further distinguishes the trial’s enrollment from its approximate planned randomization figure and identifies a planning illustration based on stated assumptions. Planning calculations concern design assumptions; they are not observed power and do not establish the strength of the eventual evidence. Keeping these categories separate helps prevent planned sample size, recorded enrollment, and outcome results from being conflated.
Finally, the safety record demonstrates the need to preserve denominators and time categories. On-treatment counts and post-treatment death entries are recorded separately, and the latter lack corresponding at-risk figures. Treating such entries as directly interchangeable could misrepresent what the data describe. Careful interpretation begins with the exact population, period, endpoint, and denominator attached to each statistic.
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 the primary question is that the registry record does not report the RFS event counts, a treatment-effect estimate, or a confidence interval. It also does not present the primary outcome as one comparison. Therefore, the primary treatment contrast cannot be quantified or judged for precision from this record.
Although the record gives the RFS definition, cutoff date, and some censoring rules, it refers the handling of events after prolonged loss to follow-up to an analysis plan whose details are not reported in the registry record. Imputation procedures, sensitivity analyses, and checks of assumptions about censoring are not reported in the registry record either.
The statistical model, standard-error method, and full trial analysis plan are not reported in the registry record. Neither are the multiplicity strategy, the detailed rationale for the trial’s sample size, or baseline outcome information. The presence of a planning illustration with stated assumptions does not fill these gaps or describe the trial’s own justification.
The safety data include on-treatment counts and post-treatment death entries, but the latter are listed with at-risk figures of 0. The record does not explain the denominator for those post-treatment death counts. The listed serious-event term percentages also lack corresponding placebo percentages in the information, limiting direct comparison of those terms.
These limitations concern what can be interpreted from the registry record, not necessarily what was collected or analyzed in the full study. Additional information is not reported in the registry record, so conclusions should be confined to the design, definitions, and descriptive figures that the record actually states.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD). — NCT01682083.
- Registry record last updated 2026-04-21; status last verified 2026-04.
- Results first posted 2018-09-26.
- 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
COMBI-AD is listed as a completed Phase III randomized, double-blind, parallel-group trial sponsored by Novartis Pharmaceuticals. It enrolled 870 and compared dabrafenib plus trametinib with matching placebos after surgery for high-risk BRAF V600 mutation-positive melanoma. The study description says approximately 852 patients were planned for 1:1 randomization, stratified by mutation status and disease stage.
The primary outcome was the percentage of participants with RFS events in the ITT population over approximately 4 years. RFS included recurrence or death from any cause. The registry specifies censoring rules but does not report the primary event counts or a single comparison in the record. It also lists secondary survival and relapse outcomes.
Serious and other adverse-event participant counts are recorded for both on-treatment groups, alongside separate post-treatment death entries. Several serious adverse-event terms and percentages are listed. Details needed for a complete efficacy and safety interpretation, including the primary effect estimate and its precision, are not reported in the registry record.