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 Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia (NCT01854918), a randomized phase 3 study. The primary outcome is Number of Participants With Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01854918 |
| Phase | Phase 3 |
| Condition | Hyperlipidemia and Mixed Dyslipidemia |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | None (open label) |
| Enrollment | 3681 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Amgen |
| Results posted | Yes |
2. Clinical Question
Population
Adults with hyperlipidemia and adults with mixed dyslipidemia entered a phase 3, randomized extension study. The registry record reports enrollment of 3681. The primary safety outcome population is described as all randomized participants in year 1, and randomized participants on study who received at least 1 dose of evolocumab in the all-IP period in years 2-3.
Intervention
During the first year, participants in the evolocumab group received evolocumab plus standard of care. In the all-IP period, evolocumab continued alongside standard of care. The listed dosing options were 140 mg every 2 weeks or 420 mg every month, based on participant choice.
Comparator
During the SOC-controlled first year, the comparison was standard of care alone versus evolocumab plus standard of care. Participants initially assigned to standard of care began evolocumab at week 48 for the all-IP period. Thus, the later-period groups represent different treatment histories, not a continued comparison with a group receiving standard of care alone.
Primary question
The primary outcome was the number of participants with adverse events over 48 weeks in the SOC-controlled period and up to 2 years in the all-IP period. The registry record reports adverse-event counts, including serious events, other events, and deaths. It does not report a single treatment-effect estimate or a statistical comparison for this outcome. The secondary outcomes include LDL-C change and percent change at Weeks 48 and 104, but their results are not reported in the registry record.
3. Trial Design
This was a phase 3, randomized, parallel-group, open-label study. Its official title describes a multicenter, controlled, open-label extension to assess long-term safety and efficacy of AMG 145, the study name for evolocumab. The study status is completed, and the registry record lists enrollment of 3681.
The first year was the SOC-controlled period. One group received standard of care, while the other received evolocumab plus standard of care. At week 48, participants in the standard-of-care group began evolocumab, with standard of care, for approximately 2 years. Participants who had already received evolocumab plus standard of care continued that combination into the all-IP period for approximately 2 years. The dose options were 140 mg every 2 weeks or 420 mg every month, based on participant choice.
Because treatment changed after week 48, the first-year comparison addresses a different contrast from the later-period safety descriptions. The later-period groups are distinguished by their treatment histories: SOC followed by evolocumab plus SOC, or evolocumab plus SOC throughout. The later data also include a total group. These follow-up descriptions should not be read as an unchanged randomized comparison between evolocumab and standard of care alone.
The primary outcome covers adverse events over 48 weeks in the SOC-controlled period and up to 2 years in the all-IP period. The registry record names percent change from baseline in LDL-C and change from baseline in LDL-C at Weeks 48 and 104 as secondary outcomes. It does not report the results for those LDL-C outcomes or further details of the randomization procedure, allocation ratio, or masking beyond stating that masking was none.
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: Participants were randomized in a 2:1 ratio to receive evolocumab plus standard of care (SOC) or SOC alone for the first year. In years 2 and 3 all participants received evolocumab. Randomization was stratified by the parent study and parent study dose frequency (every 2 weeks \[Q2W\] or once monthly \[QM\]).
SOC-controlled Period (Year 1)
| Stage | Standard of Care | Evolocumab + Standard of Care |
|---|---|---|
| STARTED | 1227 | 2454 |
| Received Evolocumab | 5 | 2452 |
| COMPLETED | 1197 | 2391 |
| NOT COMPLETED | 30 | 63 |
Reasons for not completing this period:
| Reason | Standard of Care | Evolocumab + Standard of Care |
|---|---|---|
| Withdrawal by Subject | 20 | 49 |
| Decision by Sponsor | 2 | 1 |
| Lost to Follow-up | 3 | 8 |
| Death | 5 | 5 |
All-IP Period (Years 2 and 3)
| Stage | Standard of Care | Evolocumab + Standard of Care |
|---|---|---|
| STARTED | 1197 | 2391 |
| Received Evolocumab | 1152 | 2291 |
| COMPLETED | 1079 | 2196 |
| NOT COMPLETED | 118 | 195 |
Reasons for not completing this period:
| Reason | Standard of Care | Evolocumab + Standard of Care |
|---|---|---|
| Withdrawal by Subject | 78 | 117 |
| Decision by Sponsor | 8 | 11 |
| Lost to Follow-up | 27 | 51 |
| Death | 5 | 16 |
Analysis population for the primary outcome, as defined in the registry: All randomized participants (year 1) and randomized participants on study and who received at least 1 dose of evolocumab in the all-IP period (years 2-3).
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 randomized participants
| Characteristic | Unit | Standard of Care | Evolocumab + Standard of Care | Total |
|---|---|---|---|---|
| Participants analysed | 1227 | 2454 | 3681 | |
| Age, Continuous | years | 58.8 (SD 10.7) | 58.6 (SD 10.7) | 58.7 (SD 10.7) |
| Age, Customized: < 65 years | Participants | 823 | 1665 | 2488 |
| Age, Customized: ≥ 65 years | Participants | 404 | 789 | 1193 |
| Sex: Female, Male: Female | Participants | 560 | 1176 | 1736 |
| Sex: Female, Male: Male | Participants | 667 | 1278 | 1945 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 58 | 109 | 167 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 1169 | 2345 | 3514 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 0 | 0 | 0 |
| Race/Ethnicity, Customized: American Indian or Alaska Native | Participants | 2 | 5 | 7 |
| Race/Ethnicity, Customized: Asian | Participants | 152 | 288 | 440 |
| Race/Ethnicity, Customized: Black or African American | Participants | 49 | 84 | 133 |
| Race/Ethnicity, Customized: Native Hawaiian or Other Pacific Islander | Participants | 2 | 2 | 4 |
| Race/Ethnicity, Customized: White | Participants | 1003 | 2041 | 3044 |
| Race/Ethnicity, Customized: Other | Participants | 16 | 30 | 46 |
| Race/Ethnicity, Customized: Mixed Race | Participants | 3 | 4 | 7 |
| Region: North America | Participants | 514 | 1001 | 1515 |
| Region: Europe | Participants | 504 | 1018 | 1522 |
| Region: Asia Pacific | Participants | 209 | 435 | 644 |
| Parent Study Baseline Low-density Lipoprotein Cholesterol (LDL-C) Concentration | mg/dL | 125.8 (SD 49.3) | 127.4 (SD 51.7) | 126.9 (SD 50.9) |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Adverse Events, measured over 48 weeks in the SOC-controlled period and up to 2 years in the All-IP period.
| Element | Registry entry |
|---|---|
| Result type | Count Of Participants |
| Measure of spread | not applicable |
| Unit | Participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with adverse events. It is a safety outcome, not a measure of LDL-C lowering or another efficacy response. The registry record separates the first-year SOC-controlled period from the all-IP period, which lasted up to 2 years. It describes the analysis population as all randomized participants in year 1 and, for years 2-3, randomized participants who remained on study and had received at least 1 dose of evolocumab.
The registry record describes adverse-event severity using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. The grades are defined as grade 1, mild; grade 2, moderate; grade 3, severe; grade 4, life-threatening; and grade 5, death due to an adverse event. The posted results give counts for serious adverse events, other adverse events, and deaths. The registry record does not provide a single combined treatment-effect estimate for the primary endpoint.
Counting participants with events is useful for describing how many people in the specified groups experienced an event during follow-up. It does not, by itself, describe the timing, duration, recurrence, or severity distribution of every event. Nor does a count establish that any difference between groups is attributable to treatment. Those interpretations require suitable analyses and details about follow-up and event definitions, which are not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
In the SOC-controlled first year, the posted results report 104 serious adverse events among 1227 participants in the standard-of-care group and 195 among 2454 participants in the evolocumab-plus-standard-of-care group. For other adverse events, the corresponding counts are 334 among 1227 and 681 among 2454. The recorded death counts are 5 in each group. These are descriptive counts; the registry record does not report a comparative estimate, confidence interval, or p-value for these outcomes.
For years 2-3, the SOC-then-evolocumab-plus-SOC group has 181 serious events among 1197 participants, 498 other events among 1197 participants, and 5 deaths. The group treated with evolocumab plus standard of care throughout has 344 serious events among 2391 participants, 928 other events among 2391 participants, and 16 deaths. The reported total for years 2-3 is 525 serious events among 3588 participants, 1426 other events among 3588 participants, and 21 deaths.
The later-period groups have different treatment histories, and the original standard-of-care group began evolocumab at week 48. Therefore, the later counts do not represent a comparison of continued evolocumab against continued standard of care alone. The total for years 2-3 is a descriptive summary across those treatment histories. It should not be interpreted as a randomized treatment contrast.
The counts are not rates adjusted for time at risk, and the registry record does not report such an adjustment. The period durations are described as 48 weeks and up to 2 years, so follow-up is not presented as identical for every participant. A count alone also does not indicate how many events an individual experienced, when they occurred, or how long they lasted. The record does not provide participant-level data or event-time summaries to address those questions.
Top reported serious-event terms include osteoarthritis at 1.8%, angina pectoris at 0.8%, non-cardiac chest pain at 0.8%, atrial fibrillation at 0.6%, acute myocardial infarction at 0.5%, and pneumonia at 0.5%. These percentages are listed for the serious-event terms; their specific denominator and method of calculation are not reported in the registry record. The posted results also list LDL-C outcomes at Weeks 48 and 104, but not their numerical findings. Consequently, the safety counts can be described, while a comparative safety conclusion or an efficacy conclusion cannot be drawn from the reported results alone.
9. Statistical Methods Explained
The posted primary outcome is a count of participants with adverse events, so the result is a categorical, participant-level summary. The registry record reports group denominators and event counts for serious events, other events, and deaths. These counts describe what was recorded in each group and period. They are not themselves estimates of a treatment effect, and the registry record does not give inferential comparisons for them.
What does a participant count capture?
A count of participants with an event records whether participants experienced the outcome under the registry’s reporting definition. It does not necessarily count every event episode. A participant may have more than one event, but a participant-level count and an event-level count answer different questions. The posted results identify the primary outcome as the number of participants with adverse events, while the serious and other event counts are reported alongside group sizes. The registry record does not provide enough detail to determine whether each displayed count represents unique participants, event episodes, or another tabulation convention for every adverse-event category. That distinction is not reported in the registry record.
General statistical explanation: a denominator helps put an event count in context, but a raw count can be affected by how many people were followed and for how long. A rate or a time-to-event analysis can account for differing exposure or follow-up in ways a simple count does not. Those methods require appropriate data and definitions. The registry record does not report an adjusted rate or time-to-event analysis for these outcomes.
Why distinguish the two follow-up periods?
The first-year period is described as SOC-controlled. Its groups received different assigned regimens: standard of care alone, or evolocumab plus standard of care. After week 48, the standard-of-care group began evolocumab, while the other group continued evolocumab plus standard of care. Thus, years 2-3 describe safety under the later treatment histories, rather than preserving the original first-year contrast.
General statistical explanation: a randomized comparison is most directly interpretable when the groups remain assigned to contrasting strategies over the period being compared and the analysis follows a prespecified approach. When treatment changes, later comparisons can reflect prior exposure, continued exposure, selection into follow-up, and differences in time observed. The registry record does not report an analysis that adjusts for those factors. The later-period counts are therefore best read as descriptive summaries by treatment history.
What can uncertainty measures add?
General statistical explanation: a confidence interval gives a range of values compatible with the data under the analysis assumptions. It helps show the precision of an estimate, rather than only its direction or a significance label. A p-value, when used, addresses how compatible the observed data are with a specified null model; it does not quantify the size or clinical importance of an effect. Neither a comparative estimate nor a confidence interval or p-value for the primary safety outcome is reported in the registry record. They should not be inferred from the counts alone.
What do the planning assumptions mean?
The registry record describes planning illustrations based on the observed effect, with a two-sided significance level of 0.05, equal allocation between two arms, and a normal approximation. The intended effect is a stated fraction of the observed effect. For time-to-event tables, the described output is the total number of events; other outputs are participants per arm. These are planning illustrations, not observed trial results and not observed power. The registry record does not report the trial’s own sample-size justification or the assumptions used to choose its enrollment.
General statistical explanation: planning calculations estimate the information or enrollment that might be needed for a future study under selected assumptions. Their relevance depends on whether the assumed effect, variability, allocation, analysis, and follow-up match the planned study. A planning illustration based on an observed effect should not be taken as evidence that the trial had a particular probability of detecting an effect. The registry record does not report interim analyses or details of the statistical analysis plan.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists a primary adverse-event outcome and secondary LDL-C outcomes: percent change from baseline and change from baseline at Weeks 48 and 104. It does not report numerical results for the LDL-C outcomes. It also does not report a multiplicity strategy describing how inference across outcomes or time points was handled. Without such details and the corresponding estimates, the LDL-C outcomes cannot be interpreted as confirmatory or exploratory on the basis of the registry record alone.
The registry record does not report a missing-data method, the amount or pattern of missing outcome data, or how missing observations were handled. It does not report an imputation method or a sensitivity analysis for missing data. These omissions matter because follow-up extends across different periods and the later-period population is described as participants on study who had received at least 1 dose of evolocumab.
The primary outcome population is described for year 1 as all randomized participants and for years 2-3 as randomized participants on study who received at least 1 dose of evolocumab in the all-IP period. The record does not provide further details about analysis populations, adherence, withdrawals, or exclusions. It also does not report an analysis entry giving a statistical comparison for the primary outcome. The registry record does not report the prespecified multiplicity, missing-data, or analysis-population procedures.
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 |
|---|---|---|---|
| Year 1: Standard of Care | 104 | 1227 | 8.5% |
| Year 1: Evolocumab + Standard of Care | 195 | 2454 | 7.9% |
| Years 2-3: SOC / Evolocumab + SOC | 181 | 1197 | 15.1% |
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 344 | 2391 | 14.4% |
| Years 2-3: Total | 525 | 3588 | 14.6% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Year 1: Standard of Care | 5 of 1227 |
| Year 1: Evolocumab + Standard of Care | 5 of 2454 |
| Years 2-3: SOC / Evolocumab + SOC | 5 of 1197 |
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 16 of 2391 |
| Years 2-3: Total | 21 of 3588 |
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 |
|---|---|
| Year 1: Standard of Care | 334 of 1227 |
| Year 1: Evolocumab + Standard of Care | 681 of 2454 |
| Years 2-3: SOC / Evolocumab + SOC | 498 of 1197 |
| Years 2-3: Evolocumab + SOC / Evolocumab + SOC | 928 of 2391 |
| Years 2-3: Total | 1426 of 3588 |
Most frequent serious adverse event terms
| Event term | Organ system | Year 1: Standard of Care | Year 1: Evolocumab + Standard of Care | Years 2-3: SOC / Evolocumab + SOC | Years 2-3: Evolocumab + SOC / Evolocumab + SOC | Years 2-3: Total |
|---|---|---|---|---|---|---|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | 5 of 1227 | 12 of 2454 | 22 of 1197 | 22 of 2391 | 44 of 3588 |
| Angina pectoris | Cardiac disorders | 0 of 1227 | 7 of 2454 | 10 of 1197 | 8 of 2391 | 18 of 3588 |
| Angina unstable | Cardiac disorders | 6 of 1227 | 7 of 2454 | 4 of 1197 | 11 of 2391 | 15 of 3588 |
| Non-cardiac chest pain | General disorders | 3 of 1227 | 4 of 2454 | 10 of 1197 | 8 of 2391 | 18 of 3588 |
| Acute myocardial infarction | Cardiac disorders | 4 of 1227 | 8 of 2454 | 3 of 1197 | 12 of 2391 | 15 of 3588 |
| Pneumonia | Infections and infestations | 1 of 1227 | 0 of 2454 | 4 of 1197 | 12 of 2391 | 16 of 3588 |
| Atrial fibrillation | Cardiac disorders | 3 of 1227 | 1 of 2454 | 7 of 1197 | 7 of 2391 | 14 of 3588 |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | 1 of 1227 | 1 of 2454 | 6 of 1197 | 6 of 2391 | 12 of 3588 |
| Coronary artery disease | Cardiac disorders | 4 of 1227 | 3 of 2454 | 2 of 1197 | 7 of 2391 | 9 of 3588 |
| Cardiac failure congestive | Cardiac disorders | 0 of 1227 | 1 of 2454 | 3 of 1197 | 6 of 2391 | 9 of 3588 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Year 1: Standard of Care | Year 1: Evolocumab + Standard of Care | Years 2-3: SOC / Evolocumab + SOC | Years 2-3: Evolocumab + SOC / Evolocumab + SOC | Years 2-3: Total |
|---|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | 108 of 1227 | 201 of 2454 | 151 of 1197 | 253 of 2391 | 404 of 3588 |
| Upper respiratory tract infection | Infections and infestations | 55 of 1227 | 104 of 2454 | 99 of 1197 | 178 of 2391 | 277 of 3588 |
| Hypertension | Vascular disorders | 56 of 1227 | 87 of 2454 | 78 of 1197 | 180 of 2391 | 258 of 3588 |
| Arthralgia | Musculoskeletal and connective tissue disorders | 38 of 1227 | 106 of 2454 | 80 of 1197 | 162 of 2391 | 242 of 3588 |
| Back pain | Musculoskeletal and connective tissue disorders | 35 of 1227 | 83 of 2454 | 78 of 1197 | 147 of 2391 | 225 of 3588 |
| Bronchitis | Infections and infestations | 43 of 1227 | 78 of 2454 | 70 of 1197 | 132 of 2391 | 202 of 3588 |
| Influenza | Infections and infestations | 28 of 1227 | 66 of 2454 | 60 of 1197 | 115 of 2391 | 175 of 3588 |
| Myalgia | Musculoskeletal and connective tissue disorders | 43 of 1227 | 88 of 2454 | 61 of 1197 | 67 of 2391 | 128 of 3588 |
Serious events with the highest arm-level rate: osteoarthritis (1.8%), angina pectoris (0.8%), non-cardiac chest pain (0.8%), atrial fibrillation (0.6%), acute myocardial infarction (0.5%).
The serious-adverse-event counts are 104 among 1227 participants for standard of care and 195 among 2454 participants for evolocumab plus standard of care in year 1. In years 2-3, the counts are 181 among 1197 in the SOC-then-evolocumab-plus-SOC group and 344 among 2391 in the evolocumab-plus-SOC group. The reported later-period total is 525 among 3588. These are counts with the corresponding group sizes, not adjusted comparisons.
The registry record also reports other adverse-event counts and deaths. Those categories should not be combined or treated as interchangeable: the outcome description uses CTCAE severity grades, and the record lists deaths separately. Death counts are 5 in each first-year group, followed by 5 and 16 in the two years 2-3 groups and 21 for the later-period total. The record does not report a comparative analysis of deaths.
Top serious-event terms are listed with percentages, including osteoarthritis at 1.8%. The registry record does not report the denominator or calculation details for these term percentages. General statistical explanation: descriptive event counts can identify the kinds of safety information being recorded, but a comparison requires attention to follow-up, group assignment, uncertainty, and event definitions. The registry record does not provide a single comparative safety estimate.
12. What the Result Does, and Does Not, Mean
The posted results document adverse-event counts in a randomized, open-label extension with a first-year SOC-controlled period and a later all-IP period. They describe serious events, other events, and deaths by group and follow-up period. They also list several serious-event terms with percentages. This is useful descriptive information about the safety outcomes recorded in the registry.
The counts do not, by themselves, establish that one regimen caused more or fewer events than another. The record does not report an effect estimate with a confidence interval or a statistical test for the primary outcome. Follow-up differs in duration across the described periods, and participants initially receiving standard of care began evolocumab after week 48. The later-period groups therefore do not offer a continuing comparison against standard of care alone.
The record also does not report numerical results for the secondary LDL-C outcomes at Weeks 48 and 104. Although these outcomes are named, no conclusion about their observed changes can be drawn from the registry information. No medical recommendation follows from these descriptive results.
General statistical explanation: interpretation of a clinical study depends not only on the observed values, but also on how outcomes were defined, how missing observations were handled, which analyses were planned, and how uncertainty was quantified. Several of those details are not reported in the registry record. The appropriate reading is therefore limited to the posted counts and their stated populations and periods, without extending them into unsupported causal or efficacy claims.
13. Why This Trial Matters Statistically
This study is statistically notable for separating safety reporting into a first-year SOC-controlled period and an all-IP period that followed a treatment change. That distinction is essential: the first-year groups differ in whether evolocumab was added to standard of care, while participants in the initial standard-of-care group began evolocumab after week 48. Later safety counts therefore describe outcomes under treatment histories that include evolocumab, rather than a persistent comparison with standard of care alone.
The outcome is reported as participant counts, with group sizes, for serious events, other events, and deaths. These summaries allow a reader to see the scale and categories of recorded outcomes, but not the precision of a between-group contrast. The registry record does not report comparative effect estimates or confidence intervals for the primary outcome. It also does not report results for the listed LDL-C outcomes, so the available results do not support an efficacy interpretation.
General statistical explanation: long-term follow-up can add information about outcomes over time, but changes in treatment and follow-up populations can complicate direct comparisons. Clear reporting of analysis populations, missing-data handling, time at risk, and uncertainty helps readers distinguish descriptive safety summaries from causal estimates. Those details are not reported in the registry record, making careful attention to the period and group definitions particularly important.
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 adverse-event counts but not a comparative estimate, confidence interval, or p-value for the primary outcome. Counts alone do not establish the magnitude or precision of a treatment contrast. The record does not report adjusted rates or a time-to-event analysis, and it does not give details about time at risk for individual participants.
The change in treatment at week 48 limits direct interpretation of the later-period groups as a comparison of evolocumab against standard care alone. The later groups differ in their prior treatment histories, and the registry record describes the years 2-3 population as participants on study who received at least 1 dose of evolocumab. Further details about follow-up, withdrawals, adherence, or exclusions are not reported in the registry record.
The registry record does not report the missing-data approach, multiplicity handling, or a detailed statistical analysis plan. It does not explain the denominator or calculation method for the percentages attached to top serious-event terms. The numerical results for the LDL-C outcomes are not reported in the registry record. These limitations restrict interpretation to the descriptive safety counts and outcome definitions that are stated, rather than supporting broader comparative or efficacy conclusions.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Open-label Extension Study of Evolocumab (AMG 145) in Adults With Hyperlipidemia and Mixed Dyslipidemia — NCT01854918.
- Registry record last updated 2019-06-11; status last verified 2019-05.
- Results first posted 2019-06-11.
- 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
NCT01854918 is a completed phase 3, randomized, parallel-group, open-label extension study of evolocumab with standard of care in adults with hyperlipidemia and mixed dyslipidemia. The registry record lists enrollment of 3681 and describes a 48-week SOC-controlled period followed by an all-IP period of up to 2 years.
The primary outcome is the number of participants with adverse events. Posted results include serious-event counts, other-event counts, and deaths for the first-year groups and the years 2-3 treatment-history groups. The registry record also lists secondary LDL-C outcomes at Weeks 48 and 104, but their numerical results are not reported in the registry record.
The safety findings are descriptive counts. Comparative statistical estimates, missing-data procedures, multiplicity handling, and detailed analysis methods are not reported in the registry record.