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 A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) (NCT01894022), a na phase 3 study. The primary outcome is Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01894022 |
| Phase | Phase 3 |
| Condition | Hypertension |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 19 |
| Arms in the primary outcome | n/a |
| Lead sponsor | GlaxoSmithKline |
| Results posted | Yes |
2. Clinical Question
Population
Participants with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) who entered an extension study after Study AMB115811. The primary safety outcome applies to the Safety (Extension) Population: participants who enrolled and took at least one dose of study treatment during the extension.
Intervention
Ambrisentan, initially at 5 mg once daily. At the investigator’s discretion, participants could remain at that dose, increase to 10 mg once daily, or return to 5 mg once daily.
Comparator
There was no randomized control group in the extension. The registry separates participants by whether they had previously received placebo or ambrisentan in Study AMB115811; those groups are not a like-for-like control comparison.
Primary question
How many participants experienced any adverse event or serious adverse event during the extension, from the entry visit through approximately 16 months? The registry also lists secondary outcomes covering walking distance, functional class, exercise symptoms, clinical worsening, quality of life, and NT-proBNP.
This is a safety-focused question in a continuing-treatment setting. The extension was open label, and participants received ambrisentan rather than being assigned to a placebo or another randomized comparator. The posted serious and other adverse-event counts are separated according to prior treatment in Study AMB115811. They describe the observed groups, not the effect of ambrisentan relative to a concurrent control.
The registry describes the study as a long-term extension. Participants could remain for a minimum of 18 months, with possible continuation beyond that period under specified conditions. The primary endpoint, however, has a stated timeframe of up to approximately 16 months. These are distinct descriptions in the record; it does not explain how the endpoint timeframe relates to the planned extension duration.
3. Trial Design
This was a Phase 3, open-label, single-group extension study of ambrisentan in participants with inoperable CTEPH. The study followed Study AMB115811, and the final visit in that earlier study served as the extension entry visit. The registry lists allocation as not applicable and masking as none. The design therefore does not support a randomized comparison between the prior-treatment groups.
The registry reports an enrollment of 19. Participants began ambrisentan at 5 mg once daily. According to the arm description, the investigator could keep the dose at 5 mg, increase it to 10 mg, or adjust it back to 5 mg at the investigator’s discretion. The registry does not report how many participants received each dose or how often dose changes occurred.
The study started on 2014-01-23, and its primary completion date is listed as 2015-11-18. Its status is terminated. The reason for termination is not reported in the registry record. The record describes a minimum extension period of 18 months, with possible continuation until local approval for inoperable CTEPH, discontinuation or non-approval of development, or a decision by the investigator or participant to stop. It does not report how long each participant remained in the study.
The primary purpose stated in the registry is to provide clinically relevant information on long-term safety. The primary outcome counts participants with any adverse event or serious adverse event. Secondary outcomes include change in six-minute walking distance, WHO functional class, Borg CR10 Scale after exercise, clinical worsening, SF-36 quality of life, and percent change in plasma NT-proBNP. The record lists 24 outcome measures but does not report analysis results for those secondary measures in the information.
The prior-placebo and prior-ambrisentan groups describe participants’ treatment history in the earlier study. Because extension participants received ambrisentan and were not randomized between these histories, differences between the groups may reflect their earlier treatment or other differences between participants. The registry record does not report an adjusted comparison intended to separate those influences.
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: Out of the 33 participants randomized (16 participants in the Placebo arm and 17 in the Ambrisentan arm) in study AMB115811, a total of 19 participants were enrolled in this extension study.
Overall Study
| Stage | Previous Placebo | Previous Ambrisentan |
|---|---|---|
| STARTED | 9 | 10 |
| COMPLETED | 0 | 0 |
| NOT COMPLETED | 9 | 10 |
Reasons for not completing this period:
| Reason | Previous Placebo | Previous Ambrisentan |
|---|---|---|
| Death | 1 | 0 |
| Adverse Event, non-fatal | 1 | 0 |
| Study Closed/terminated | 7 | 10 |
Analysis population for the primary outcome, as defined in the registry: Safety (Extension) 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.
Population: Participant characteristics at the start of the extension study.
| Characteristic | Unit | Previous Placebo | Previous Ambrisentan | Total |
|---|---|---|---|---|
| Participants analysed | 9 | 10 | 19 | |
| Age, Continuous | Years | 63.0 (inter quartile range 7.99) | 61.0 (inter quartile range 11.71) | 63.0 (inter quartile range 10.06) |
| Sex: Female, Male: Female | Participants | 6 | 4 | 10 |
| Sex: Female, Male: Male | Participants | 3 | 6 | 9 |
| Race/Ethnicity, Customized: Asian - East Asian Heritage | Participants | 2 | 1 | 3 |
| Race/Ethnicity, Customized: Asian - Japanese Heritage | Participants | 2 | 1 | 3 |
| Race/Ethnicity, Customized: White - White/Caucasian/European Heritage | Participants | 5 | 8 | 13 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE), measured over From entry visit of the extension study up to approximately 16 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 with any adverse event (AE) or serious adverse event (SAE), measured from the extension entry visit through approximately 16 months. The registry defines an AE as an untoward medical occurrence temporally associated with use of a medicinal product, whether or not it is considered related to that product. An SAE is an untoward medical occurrence that, at any dose, results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect.
A participant count is a binary-outcome summary: each participant is classified according to whether the event occurred during the specified period. The endpoint is intended to describe how many participants in the extension safety population experienced an event, rather than the number of separate event episodes or the event rate over person-time. The registry does not report a time-to-event analysis for this primary outcome.
Safety endpoints are used in extension studies to record adverse occurrences during continued exposure. In general, counting participants with an event gives a direct description of how common the recorded experience was in the observed group. It does not by itself determine whether an event was caused by treatment. The registry’s AE definition explicitly includes events whether or not they are considered related to the medicinal product.
The posted figures separately identify participants with serious events and participants with other events. Those categories are useful for describing the reported safety experience, but they should not be added to obtain a total with any AE or SAE unless the record establishes that the categories are mutually exclusive and gives the relevant combined result. A combined primary-endpoint count is not reported in the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry reports serious adverse events for two groups defined by treatment in Study AMB115811. Among participants whose prior treatment was placebo, 3 of 9 were reported with a serious adverse event; among those whose prior treatment was ambrisentan, 0 of 10 were reported with a serious adverse event. For other adverse events, the corresponding counts are 8 of 9 and 6 of 10. These are observed counts in a small extension population, not estimates from a randomized comparison.
The serious-event count of 0 in the prior-ambrisentan group means that no participant in that group was reported with a serious adverse event in the posted figures. It does not establish that serious events cannot occur, nor does it demonstrate a difference between treatment strategies. The prior-placebo group also received ambrisentan during the extension, so neither group is a concurrent untreated control. Their earlier treatment histories do not create randomization within the extension.
The registry lists serious-event terms including Cardiac failure (22.2%), Atrial fibrillation (11.1%), Bradyarrhythmia (11.1%), Right ventricular failure (11.1%), Ventricular tachycardia (11.1%), and Vomiting (11.1%). These percentages are presented as registry listings; the record excerpt does not provide enough detail to infer a comparative risk, establish causality, or determine whether a participant could contribute to more than one term.
The primary endpoint combines any AE or SAE, but the counts described in the posted safety results distinguish serious events from other events. The record does not report the combined number of participants with any AE or SAE as a single primary-endpoint result. Nor does it provide confidence intervals, a hypothesis test, an adjusted effect estimate, or a time-to-event estimate for that endpoint. Consequently, the counts support a descriptive reading, not a claim of statistical evidence for or against a treatment difference.
The record identifies a safety population that includes participants who enrolled and took at least one dose during the extension. The reported at-risk counts are 9 and 10 for the prior-placebo and prior-ambrisentan groups, respectively. The registry does not report further detail on participants who enrolled but did not take a dose, missing safety assessments, or how incomplete follow-up was handled. The follow-up period is described as up to approximately 16 months for the primary endpoint, while the study description allows a minimum extension duration of 18 months. The record does not reconcile these timeframes.
Although the registry lists secondary clinical and laboratory outcomes, numerical results for those outcomes are not reported in the record. The safety counts therefore cannot be used to infer changes in walking distance, functional class, symptoms, clinical worsening, quality of life, or NT-proBNP. Overall, the posted data characterize reported adverse events among extension participants; they do not establish a causal treatment effect or a comparative estimate of benefit and harm.
9. Statistical Methods Explained
What does a participant count describe?
For a binary endpoint such as whether a participant had an AE or SAE, each person is classified as having or not having the event during the stated observation period. The count describes the number of people with an event in the group being summarized. It is not the same as a count of event episodes: one participant may experience more than one event, while the participant count still records that person once for the endpoint.
General statistical explanation: a proportion expresses an event count relative to the number of participants assessed. The registry’s group summaries give both at-risk counts and affected-participant counts for serious and other events. Those descriptions allow a reader to understand the denominators used for those safety summaries. They do not, on their own, provide the combined count for the primary endpoint of any AE or SAE.
Why does the design matter for interpreting group differences?
General statistical explanation: random allocation helps make treatment groups comparable, on average, with respect to measured and unmeasured baseline characteristics. In a single-group extension with no random allocation, a division based on prior treatment is not equivalent to a randomized control comparison. Participants in the prior-treatment groups may differ for reasons that are not fully described in the registry.
In this study, the groups are labelled Previous Placebo and Previous Ambrisentan, reflecting treatment history in Study AMB115811. The extension intervention was ambrisentan. A difference in observed safety counts between these groups could relate to prior treatment, participant characteristics, follow-up, chance, or other factors. The posted counts cannot isolate the contribution of any one explanation. The registry does not report an adjusted model to address such differences.
What can confidence intervals add?
General statistical explanation: a confidence interval describes the precision of an estimated quantity under a specified statistical method. For an event proportion, a confidence interval can show how much uncertainty remains around the estimate, especially when the number of participants is limited. A wide interval signals that the data are compatible with a broad range of underlying values. A confidence interval does not remove bias from a non-randomized comparison or turn an association into a causal effect.
The registry record does not report confidence intervals for the primary safety endpoint or for the serious and other event counts. No interval should therefore be inferred from the counts alone. In particular, an observed zero count is not a precise demonstration that the underlying event probability is zero.
Why distinguish event counts from event rates?
General statistical explanation: a participant count records whether an event occurred, whereas a rate uses both the number of events and the time participants were observed. When follow-up differs between participants, rates or time-to-event methods can incorporate that variation, provided the necessary dates and assumptions are available. The primary outcome is specified as a participant count, and the registry does not report a time-to-event analysis for it. The record also does not provide person-time summaries for the safety groups.
The stated primary-outcome timeframe is from the extension entry visit up to approximately 16 months. The study description separately states that participants may remain for a minimum of 18 months and potentially longer. Without participant-level follow-up detail or an explanation of the different time descriptions, the posted event counts should be read within the endpoint timeframe given for the primary outcome rather than treated as rates over a common exposure period.
How should planning illustrations be understood?
General statistical explanation: a sample-size calculation describes how many observations a future study might need under stated assumptions about the effect to detect, the significance level, allocation, and statistical method. It is a planning exercise, not a result from the observed trial. A calculation based on an effect observed in a small study can be especially uncertain because that effect estimate may itself be imprecise.
The planning approach described for this study uses a two-sided significance level of 0.05, equal allocation between arms, and a normal approximation, with the target effect defined as a stated fraction of the observed effect. For time-to-event outcomes it expresses planning requirements as a total number of events; for other outcomes it expresses them as participants per arm. These assumptions do not describe the design of this extension, which is single group and has no randomized allocation. No numerical planning results or effect fractions are reported in the registry record. Such illustrations should not be interpreted as observed power or as evidence that the study was designed to detect a particular effect.
What analyses are reported?
The record lists 24 outcome measures and 0 analyses. It does not report a statistical model, a hypothesis test, a confidence interval, or an adjusted estimate for the primary endpoint. It also does not report how the adverse-event categories were statistically combined, how repeated events were handled beyond the participant-count description, or whether any subgroup analysis was planned. These omissions limit the statistical conclusions that can be drawn, but they do not change the descriptive meaning of the posted counts.
10. Multiplicity, Missing Data and Analysis Populations
The registry lists multiple outcomes: the primary safety endpoint and secondary measures covering six-minute walking distance, WHO functional class, Borg CR10 Scale after exercise, clinical worsening, SF-36 quality of life, and plasma NT-proBNP, among others. When multiple outcomes are tested, the chance of at least one apparently unusual result can increase if each is assessed separately. General statistical explanation: a prespecified multiplicity strategy can control or describe that issue, for example by identifying a primary endpoint or adjusting comparisons. The registry record does not report a multiplicity plan or a hierarchy for interpreting secondary outcomes.
The record lists 24 outcome measures but 0 analyses. Numerical results and analysis details for the secondary measures are not reported in the record. It is therefore not possible to assess whether outcomes were analyzed as planned, whether any adjustment for multiple testing was applied, or how missing secondary outcome data were handled.
The primary endpoint specifies the Safety (Extension) Population: participants who enrolled and took at least one dose of study treatment during the extension. The registry does not report the number of participants with missing safety information, the handling of incomplete follow-up, or whether all endpoint assessments were available for every member of that population. It also does not report imputation methods or sensitivity analyses for missing data.
No detailed statistical analysis plan, interim-analysis procedure, or sample-size justification is reported in the registry record. The planning assumptions described for illustrations are not a substitute for a reported protocol analysis plan. Without those details, readers cannot establish which analyses were prespecified or how deviations, if any, were addressed.
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 |
|---|---|---|---|
| Previous Placebo | 3 | 9 | 33.3% |
| Previous Ambrisentan | 0 | 10 | 0.0% |
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 |
|---|---|
| Previous Placebo | 8 of 9 |
| Previous Ambrisentan | 6 of 10 |
Most frequent serious adverse event terms
| Event term | Organ system | Previous Placebo | Previous Ambrisentan |
|---|---|---|---|
| Cardiac failure | Cardiac disorders | 2 of 9 | 0 of 10 |
| Atrial fibrillation | Cardiac disorders | 1 of 9 | 0 of 10 |
| Bradyarrhythmia | Cardiac disorders | 1 of 9 | 0 of 10 |
| Right ventricular failure | Cardiac disorders | 1 of 9 | 0 of 10 |
| Ventricular tachycardia | Cardiac disorders | 1 of 9 | 0 of 10 |
| Vomiting | Gastrointestinal disorders | 1 of 9 | 0 of 10 |
| Implant site extravasation | General disorders | 1 of 9 | 0 of 10 |
| Oedema peripheral | General disorders | 1 of 9 | 0 of 10 |
| Gastroenteritis | Infections and infestations | 1 of 9 | 0 of 10 |
| Electrocardiogram repolarisation abnormality | Investigations | 1 of 9 | 0 of 10 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Previous Placebo | Previous Ambrisentan |
|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | 2 of 9 | 1 of 10 |
| Oedema peripheral | General disorders | 3 of 9 | 0 of 10 |
| Nasopharyngitis | Infections and infestations | 1 of 9 | 2 of 10 |
| Headache | Nervous system disorders | 1 of 9 | 1 of 10 |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | 1 of 9 | 1 of 10 |
| Anaemia | Blood and lymphatic system disorders | 1 of 9 | 0 of 10 |
| Cyanosis | Cardiac disorders | 1 of 9 | 0 of 10 |
| Tachycardia | Cardiac disorders | 1 of 9 | 0 of 10 |
| Hiatus hernia | Gastrointestinal disorders | 1 of 9 | 0 of 10 |
| Vomiting | Gastrointestinal disorders | 1 of 9 | 0 of 10 |
Serious events with the highest arm-level rate: cardiac failure (22.2%), atrial fibrillation (11.1%), bradyarrhythmia (11.1%), right ventricular failure (11.1%), ventricular tachycardia (11.1%).
For serious adverse events, the registry reports 3 affected participants among 9 at risk in the Previous Placebo group and 0 among 10 at risk in the Previous Ambrisentan group. For other adverse events, it reports 8 among 9 and 6 among 10, respectively. These are participant counts, not counts of all event episodes.
The group labels refer to treatment in Study AMB115811, not different randomized treatments in the extension. Participants received ambrisentan during the extension, with the dose managed at the investigator’s discretion. The counts therefore describe safety experience by prior-treatment history and should not be read as a direct comparison of ambrisentan against placebo.
The serious-event terms listed by the registry include Cardiac failure (22.2%), Atrial fibrillation (11.1%), Bradyarrhythmia (11.1%), Right ventricular failure (11.1%), Ventricular tachycardia (11.1%), and Vomiting (11.1%). The record does not report enough detail to interpret these percentages as comparative risks or to establish that any event was caused by treatment.
The primary endpoint is the number with any AE or SAE, but a combined result for that endpoint is not reported in the registry record. The serious and other event counts should not be combined into a total without information about overlap and the endpoint’s calculation.
12. What the Result Does, and Does Not, Mean
The posted results describe adverse events observed among participants in an open-label ambrisentan extension study for inoperable CTEPH. They report serious and other adverse-event counts separately for groups defined by treatment in the earlier study. This is useful descriptive information about the participants represented in those summaries, but it is not a randomized comparison of treatment strategies.
The 0 serious adverse events reported in the Previous Ambrisentan group is an observed count in that group, not evidence that serious adverse events are impossible or that risk is absent. The counts in both groups are based on a limited number of participants, and the registry does not provide confidence intervals or an adjusted comparative estimate. The posted figures therefore do not quantify the precision of a difference between groups.
The safety outcome also does not establish whether an event was caused by ambrisentan. The registry definition includes AEs whether or not considered related to the medicinal product. The serious-event terms and percentages identify reported categories, but the record does not provide a causal assessment or a comparison with a concurrent untreated group.
The record lists secondary outcomes related to exercise capacity, functional class, exercise symptoms, clinical worsening, quality of life, and NT-proBNP. Numerical findings for these outcomes are not reported in the registry record. The adverse-event counts cannot stand in for those outcomes or support conclusions about them.
Accordingly, the posted results should be interpreted as descriptive safety observations from an extension study, not as proof that ambrisentan is beneficial, ineffective, safe, or unsafe. The record does not provide the comparative design or statistical results needed to make those broader conclusions. It also does not report why the study was terminated or reconcile the primary endpoint’s approximate 16-month timeframe with the extension description’s minimum 18-month participation period.
13. Why This Trial Matters Statistically
Extension studies address a different statistical question from randomized treatment trials. They can document what occurs during continued treatment and provide follow-up beyond an earlier study, but an open-label single-group design has no concurrent randomized control. In this study, the prior-treatment groups preserve some information about participant history, yet they do not function as randomized arms during the extension.
The registry’s separation of serious and other adverse events makes the safety counts easier to describe, while also underscoring the need to keep the endpoint definition in view. The primary endpoint is a combined count of participants with any AE or SAE. The posted safety summaries separately report serious and other events, and the combined primary-endpoint result is not reported in the registry record. A reader should not assume that separate categories can be added without knowing whether they overlap or how the endpoint was derived.
The study is also a useful example of how endpoint timeframe and planned study duration can differ in a registry description. The primary outcome is stated to run through approximately 16 months, while the extension description allows a minimum of 18 months and possible longer participation. The record does not explain the relationship between these statements, so the precise exposure period underlying individual counts is not clear.
Finally, the registry identifies many secondary outcomes but reports 0 analyses. That distinction matters: a list of planned or defined outcomes is not the same as a set of reported estimates. Without numerical results, analysis methods, and precision measures, readers cannot evaluate the secondary endpoints or the statistical uncertainty around the safety summaries. The record supports a bounded descriptive interpretation rather than broad comparative inference.
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 extension was open label, had no masking, and used a single-group design with allocation listed as not applicable. The safety groups are based on prior treatment, so they are not randomized comparator arms. Differences in their observed counts cannot be attributed to prior treatment or extension treatment from these data alone.
The registry reports 19 enrolled participants, while the safety summaries give group-specific at-risk counts of 9 and 10. The primary safety population is defined as participants who enrolled and took at least one dose. The record does not report participant flow in further detail, explain whether anyone was excluded from the safety population, or describe missing safety assessments and incomplete follow-up.
The record does not provide a combined count for the primary endpoint of any AE or SAE, confidence intervals, hypothesis tests, adjusted estimates, or a time-to-event analysis. It does not state how event overlap was handled in relation to the separate serious and other event summaries. The percentages listed for serious-event terms should therefore be read as descriptive registry entries, not comparative estimates.
The study’s primary outcome timeframe is up to approximately 16 months, whereas the extension description states a minimum participation period of 18 months with possible continuation beyond that. The registry does not reconcile the timeframes or report participant-level exposure duration. The dose could also be adjusted at investigator discretion, but dose distributions and dose-specific safety outcomes are not reported.
The study status is terminated, but the reason is not reported in the registry record. A detailed statistical analysis plan, sample-size justification, multiplicity procedure, interim-analysis plan, and missing-data approach are also not reported. These gaps limit interpretation of the scope, precision, and completeness of the posted findings.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Open Label Study to Assess the Long-term Safety, Tolerability and Efficacy of Ambrisentan in Subjects With Inoperable Chronic Thromboembolic Pulmonary Hypertension (CTEPH) — NCT01894022.
- Registry record last updated 2017-09-11; status last verified 2017-08.
- Results first posted 2017-06-08.
- 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
NCT01894022 is a Phase 3, open-label, single-group extension study of ambrisentan in participants with inoperable CTEPH following Study AMB115811. The registry reports 19 enrolled participants, a start date of 2014-01-23, a primary completion date of 2015-11-18, and a status of terminated.
Participants began ambrisentan at 5 mg once daily, with possible investigator-directed adjustment to 10 mg once daily or back to 5 mg. The primary endpoint is the number of participants with any AE or SAE from extension entry through approximately 16 months. The posted safety counts are divided by previous treatment in the earlier study; they are not a randomized comparison.
The record lists 24 outcome measures and 0 analyses. It reports serious and other adverse-event counts but does not report a combined primary-endpoint result, confidence intervals, or comparative statistical estimates. The reason for termination and several analysis details are not reported in the registry record.