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 Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults (NCT02114268), a randomized phase 1 study. The primary outcome is Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT02114268 |
| Phase | Phase 1 |
| Condition | Respiratory Syncytial Virus Infections |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Triple |
| Enrollment | 342 |
| Arms in the primary outcome | n/a |
| Lead sponsor | MedImmune LLC |
| Results posted | Yes |
2. Clinical Question
Population
Healthy adult participants. The registry describes an as-treated population for the primary outcome: participants who received any study investigational product. The record does not give further demographic details in the information summarized for this trial.
Intervention
MEDI8897 was administered as a single fixed dose on Day 1. The listed regimens were 300 mg, 1000 mg, or 3000 mg intravenously, and 100 mg or 300 mg intramuscularly. The study title identifies the trial as dose-escalation, while the arm descriptions specify the regimens used.
Comparator
Placebo was administered on Day 1. The study was randomized, placebo-controlled, parallel-group, and triple-masked. The registry record does not specify which trial roles were included in the masking description.
Primary question
The primary endpoint counted participants with treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs). The registry also lists pharmacokinetic outcomes, including serum concentration measures and elimination half-life, along with participants with positive anti-drug antibodies. The central question is descriptive: what safety events and pharmacokinetic measurements were recorded after the listed regimens, within the stated follow-up periods?
This was a Phase 1 study in healthy adults, not a trial of clinical outcomes among people being treated for respiratory syncytial virus infection. Its stated purpose was to evaluate safety, tolerability, and pharmacokinetics of an extended half-life anti-RSV monoclonal antibody compared with placebo. The registry record does not report a clinical efficacy endpoint or a statistical comparison demonstrating a treatment effect.
3. Trial Design
The registry identifies NCT02114268 as a completed Phase 1 randomized, triple-masked, parallel-group, placebo-controlled dose-escalation study. The listed condition is respiratory syncytial virus infections, while the enrolled study population is described as healthy adults. The sponsor is MedImmune LLC. The study began in 2014-04, and primary completion is recorded as 2015-06. Registry enrollment is 342.
The intervention arms used single fixed doses administered on Day 1. The intravenous regimens were MEDI8897 300 mg, 1000 mg, and 3000 mg. The intramuscular regimens were MEDI8897 100 mg and 300 mg. A placebo arm is also listed. These descriptions establish the routes and assigned regimens but do not provide a detailed account of dose-escalation rules, the order of enrollment, or how randomization was implemented. Those details are not reported in the registry record.
The primary outcome is the number of participants with TEAEs and TESAEs, assessed from the start of study drug administration up to Day 391 (Day 361 +/- 30 days). The listed primary-outcome population is as-treated: participants who received any study investigational product. Secondary outcomes cover time to maximum observed serum concentration, maximum concentration, area under the serum concentration-time curve, terminal-phase elimination half-life, systemic clearance, volume of distribution, and positive anti-drug antibody status.
The record lists an enrollment figure, but this does not describe how many participants contributed data to every outcome or analysis. The adverse-event listings give separate at-risk counts for each group. The reasons for any difference between registry enrollment and outcome-specific counts are not reported in the registry record.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: There were 342 participants who were screened. A total of 136 participants met eligibility criteria and were randomized into the study.
Overall Study
| Stage | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|---|
| STARTED | 34 | 6 | 6 | 6 | 6 | 78 |
| COMPLETED | 28 | 5 | 5 | 6 | 6 | 75 |
| NOT COMPLETED | 6 | 1 | 1 | 0 | 0 | 3 |
Reasons for not completing this period:
| Reason | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|---|
| Lost to Follow-up | 4 | 1 | 1 | 0 | 0 | 2 |
| Withdrawal by Subject | 1 | 0 | 0 | 0 | 0 | 1 |
| Withdrawn by site due to noncompliance | 1 | 0 | 0 | 0 | 0 | 0 |
Analysis population for the primary outcome, as defined in the registry: The As-treated population included participants who receive any study investigational product.
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: The As-treated Population included participants who receive any study investigational product.
Only the first 6 of 7 groups are shown.
| Characteristic | Unit | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|---|---|
| Participants analysed | 34 | 6 | 6 | 6 | 6 | 78 | |
| Age, Continuous | Years | 29.2 (SD 8.6) | 34.5 (SD 8.6) | 34.3 (SD 5.6) | 33.5 (SD 6.7) | 30.7 (SD 7.8) | 30.3 (SD 7.9) |
| Sex: Female, Male: Female | Participants | 19 | 4 | 2 | 3 | 6 | 39 |
| Sex: Female, Male: Male | Participants | 15 | 2 | 4 | 3 | 0 | 39 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs), measured over From start of study drug administration up to Day 391 (Day 361 +/- 30 days).
| 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 treatment-emergent adverse events and treatment-emergent serious adverse events. An event qualifies as treatment-emergent if it was present at baseline and worsened in intensity after administration of an investigational product, or if it was absent at baseline and emerged after study drug administration. The stated observation period extends from the start of study drug administration up to Day 391 (Day 361 +/- 30 days) after the last dose.
A count answers how many participants in a group were recorded as having an event. It is a descriptive safety measure, rather than a direct measure of event severity, duration, or causation. The serious and other adverse-event counts are listed separately in the posted results. A participant count also does not indicate how many total event episodes occurred, because one participant may have more than one event; the registry’s endpoint is expressed in participants.
Safety endpoints of this kind are used to characterize events observed during exposure and follow-up, and to support transparent description of tolerability in the study population. They do not, by themselves, establish that a drug caused an event or that differences between groups are statistically reliable. The registry record does not include an inferential analysis for this endpoint, adjusted comparisons, confidence intervals, or a detailed definition of seriousness beyond its serious-event classification.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The posted adverse-event counts are descriptive and should be read group by group. For serious adverse events, the registry lists 0 affected participants among 34 at risk in the placebo group, 0 among 6 in each of the MEDI8897 300 mg intravenous, 1000 mg intravenous, and 3000 mg intravenous groups, 0 among 6 in the 100 mg intramuscular group, and 2 among 78 in the 300 mg intramuscular group. These are observed counts, not estimates adjusted for differences in group size or follow-up.
For other adverse events, the corresponding listed counts are 21 among 34 for placebo, 3 among 6 for 300 mg intravenous, 3 among 6 for 1000 mg intravenous, 5 among 6 for 3000 mg intravenous, 4 among 6 for 100 mg intramuscular, and 48 among 78 for 300 mg intramuscular. These figures describe participants with events in the posted listings. They do not show event frequency per person-time, the number of episodes, severity distributions, or a causal relationship to treatment.
The group sizes are notably different in the adverse-event listings: several dose groups have 6 at risk, whereas the placebo and 300 mg intramuscular groups have 34 and 78 at risk, respectively. Consequently, raw counts alone are not suitable for judging comparative risk. Even a percentage comparison would require care: small groups can yield unstable estimates, and the registry record does not provide uncertainty intervals or a prespecified statistical comparison for these results. No percentages should be inferred from the counts without a defined analysis.
The primary outcome combines TEAEs and TESAEs in its title, but the posted safety information separates serious events from other events. The record does not supply a single combined count for the primary endpoint, nor does it state how overlap between the categories was handled. It also does not report an analysis for any treatment comparison. The registry lists 0 analyses, so no p-value, confidence interval, or adjusted estimate is available to interpret.
These results therefore describe what was recorded in the listed groups during the stated follow-up. They do not establish that one regimen caused more or fewer events than another, and they do not determine whether the differences in raw counts are compatible with chance. The intended focus of the trial also included pharmacokinetics, but numerical results for those secondary measures are not reported in the registry record. The record’s enrollment figure should not be substituted for the at-risk counts attached to particular safety outcomes.
The trial is identified as a dose-escalation study, but the counts alone do not establish a dose-response pattern. The dose groups differ in route and group size, and no statistical trend analysis is recorded. A meaningful interpretation must retain those distinctions rather than treating all MEDI8897 recipients as a single comparable group.
9. Statistical Methods Explained
The registry describes a randomized, parallel-group study with triple masking. Randomization is a design method for assigning participants to groups; in general, it can reduce systematic differences at assignment. Masking is intended to limit the influence of knowledge about group assignment, but the record does not say which individuals were masked or give operational details. The registry also does not report the randomization procedure or allocation ratio.
What does a participant count represent?
The primary outcome uses a participant count. In general, a count records the number of people meeting an event definition, rather than the number of event episodes. A participant may experience more than one event, so a participant count and an episode count answer different questions. The posted safety results give at-risk and affected participant counts by group for serious and other adverse events.
Counts are easiest to interpret when group sizes are similar and the same follow-up and outcome definitions apply. Here, at-risk counts vary across groups. A raw count is therefore not a direct comparison of the chance of an event. Rates, risk differences, or risk ratios would require explicit calculation and a defined analysis; none is reported as a sponsor analysis in the registry record. No calculated comparison should be treated as a trial result.
Why distinguish serious from other events?
Serious adverse events are reported separately from other adverse events. This separation preserves an important safety distinction, but it does not make the event counts interchangeable. The record gives the number of participants affected in each category; it does not provide event-level detail for all events, severity grading for the other events, or an explanation of overlap. Without that information, readers should not add the categories or assume they are mutually exclusive.
What does uncertainty mean for these counts?
General statistical explanation: an estimate from a study is subject to sampling uncertainty because the observed participants are only one possible sample from a broader population. A confidence interval is a range calculated by a specified method to express uncertainty around an estimate. It does not guarantee that a particular value lies within the interval, and its interpretation depends on the method and assumptions. No confidence intervals for the primary safety counts are reported in the registry record.
Small group counts can be especially imprecise. When only a few participants are at risk, a change in one participant’s status can materially affect the group’s observed count. This is a general property of sparse data, not a claim that any specific result in this study is incorrect. The record does not report a model for sparse events, an adjustment for group differences, or a statistical test for the safety outcomes.
How should the pharmacokinetic outcomes be understood?
The listed secondary outcomes include Tmax, the time to reach maximum observed serum concentration; Cmax, the maximum observed serum concentration; AUC from time zero to infinite time, a summary of concentration over time; terminal-phase elimination half-life; systemic clearance; and volume of distribution. These are pharmacokinetic measures describing drug concentration and disposition, not clinical benefit. The record also lists the number of participants with positive anti-drug antibodies. Numerical results and analysis details for these outcomes are not reported in the registry record.
General statistical explanation: pharmacokinetic summaries can be reported with measures of location and variability, and group comparisons may require methods suited to the outcome’s scale and distribution. The choice of summary and model should follow the protocol and data characteristics. The registry record does not specify the statistical methods used for these outcomes, their summary statistics, or any inferential comparisons.
What do the planning assumptions tell readers?
The record describes sample-size 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 effect to detect is framed as a stated fraction of the observed effect. These are planning illustrations, not the trial’s own design justification and not observed power. The record does not report the protocol’s sample-size rationale, and the illustrations should not be interpreted as evidence that the trial had a particular probability of detecting an effect.
General statistical explanation: a sample-size calculation depends on assumptions about the target effect, variability or event rate, significance threshold, allocation, and analysis method. If those assumptions differ from the trial’s actual design or observed data, the calculation may not describe the study’s operating characteristics. No additional assumptions should be inferred beyond those documented in the registry record.
The registry identifies the primary outcome parameter as a number and lists no analyses. That means the record does not provide a statistical analysis plan, model specification, treatment-effect estimate, or inferential result for the primary endpoint. A descriptive count remains useful for conveying what was observed, but it is not a substitute for a comparative analysis with an uncertainty measure.
10. Multiplicity, Missing Data and Analysis Populations
The study record lists a primary safety outcome and secondary outcomes covering pharmacokinetics and anti-drug antibodies. It lists eight outcome measures overall and 0 analyses. The record does not describe how many hypotheses were tested, whether any outcomes were grouped into families, or whether an adjustment for multiple comparisons was planned. A multiplicity strategy is therefore not reported in the registry record.
General statistical explanation: when many outcomes or comparisons are examined, the chance of finding at least one apparently unusual result can increase. Prespecified prioritization and multiplicity procedures can help define how results should be interpreted. Since the analysis plan and inferential results are not recorded, no claim about control of false-positive findings can be made for this study.
The primary outcome population is described as as-treated: participants who received any study investigational product. The posted safety results also give at-risk counts by group. The registry record does not describe a separate intention-to-treat population or explain whether any participants were excluded from outcome analyses.
Missing-data procedures are not reported in the registry record. It does not state how missing adverse-event information, incomplete follow-up, or unavailable pharmacokinetic measurements were handled. Nor does it describe imputation, censoring rules, sensitivity analyses, or the number of participants with missing data for each outcome. The enrollment figure should not be assumed to be the denominator for every outcome. Without those details, the extent to which incomplete observations could affect the reported summaries cannot be assessed.
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 |
|---|---|---|---|
| Placebo | 0 | 34 | 0.0% |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | 0 | 6 | 0.0% |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | 0 | 6 | 0.0% |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | 0 | 6 | 0.0% |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | 0 | 6 | 0.0% |
| MEDI8897 300 Milligram (mg) Intramuscular (IM) | 2 | 78 | 2.6% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Placebo | 21 of 34 |
| MEDI8897 300 Milligram (mg) Intravenous (IV) | 3 of 6 |
| MEDI8897 1000 Milligram (mg) Intravenous (IV) | 3 of 6 |
| MEDI8897 3000 Milligram (mg) Intravenous (IV) | 5 of 6 |
| MEDI8897 100 Milligram (mg) Intramuscular (IM) | 4 of 6 |
| MEDI8897 300 Milligram (mg) Intramuscular (IM) | 48 of 78 |
Most frequent serious adverse event terms
| Event term | Organ system | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | 0 of 34 | 0 of 6 | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 78 |
| Gun shot wound | Injury, poisoning and procedural complications | 0 of 34 | 0 of 6 | 0 of 6 | 0 of 6 | 0 of 6 | 1 of 78 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Placebo | MEDI8897 300 Milligram (mg) Intravenous (IV) | MEDI8897 1000 Milligram (mg) Intravenous (IV) | MEDI8897 3000 Milligram (mg) Intravenous (IV) | MEDI8897 100 Milligram (mg) Intramuscular (IM) | MEDI8897 300 Milligram (mg) Intramuscular (IM) |
|---|---|---|---|---|---|---|---|
| Upper respiratory tract infection | Infections and infestations | 3 of 34 | 1 of 6 | 1 of 6 | 0 of 6 | 1 of 6 | 16 of 78 |
| Headache | Nervous system disorders | 6 of 34 | 0 of 6 | 1 of 6 | 1 of 6 | 0 of 6 | 7 of 78 |
| Nausea | Gastrointestinal disorders | 2 of 34 | 0 of 6 | 0 of 6 | 2 of 6 | 0 of 6 | 3 of 78 |
| Urinary tract infection | Infections and infestations | 1 of 34 | 0 of 6 | 0 of 6 | 0 of 6 | 2 of 6 | 4 of 78 |
| Vomiting | Gastrointestinal disorders | 1 of 34 | 0 of 6 | 0 of 6 | 0 of 6 | 0 of 6 | 5 of 78 |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | 1 of 34 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 4 of 78 |
| Dermatitis contact | Skin and subcutaneous tissue disorders | 0 of 34 | 1 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 3 of 78 |
| Blood creatine phosphokinase increased | Investigations | 2 of 34 | 0 of 6 | 0 of 6 | 1 of 6 | 0 of 6 | 1 of 78 |
| Cough | Respiratory, thoracic and mediastinal disorders | 0 of 34 | 0 of 6 | 0 of 6 | 0 of 6 | 0 of 6 | 4 of 78 |
| Abdominal pain | Gastrointestinal disorders | 0 of 34 | 0 of 6 | 0 of 6 | 0 of 6 | 0 of 6 | 3 of 78 |
Serious events with the highest arm-level rate: appendicitis (1.3%), gun shot wound (1.3%).
The serious-event figures are counts of affected participants, paired with the number at risk in each group. The registry lists 0 among 34 in placebo; 0 among 6 in each of the three intravenous dose groups; 0 among 6 in the 100 mg intramuscular group; and 2 among 78 in the 300 mg intramuscular group. These counts describe the entries in the record for the stated follow-up period, which extends to Day 391 (Day 361 +/- 30 days).
The registry also lists appendicitis and gun shot wound as serious adverse-event terms, each with a reported value of 1.3%. It does not identify in the information summarized for these terms which group each term belongs to. These terms should not be used to infer that other serious events did not occur unless the record explicitly establishes that.
General statistical explanation: a zero count means no affected participants were recorded in that group; it does not establish that the underlying event risk is zero. Conversely, a nonzero count does not establish causation. Unequal at-risk counts and limited group sizes matter when interpreting raw counts. Death figures are not reported in the registry record; the absence of a numerical value should not be read as a count of zero.
12. What the Result Does, and Does Not, Mean
The record documents a randomized, placebo-controlled Phase 1 study of MEDI8897 in healthy adults, with intravenous and intramuscular regimens and a placebo group. Its primary outcome concerns participants with treatment-emergent adverse events and serious adverse events during the stated observation period. The posted safety listings show group-specific counts, including serious-event counts and counts for other adverse events. These data support a descriptive account of what was recorded in the study groups.
The results do not establish that MEDI8897 caused any particular event, or that the event counts differ meaningfully between regimens. Raw counts do not adjust for group size, and the registry does not report a comparative statistical analysis, confidence intervals, or p-values. The differences in counts should not be interpreted as proof of benefit, harm, or equivalence. The record also does not provide numerical results for the listed pharmacokinetic outcomes or anti-drug antibody outcome in the information summarized for this trial.
The trial’s population and purpose limit what can be inferred. Participants were healthy adults, and the stated purpose was safety, tolerability, and pharmacokinetics. The registry record does not report clinical efficacy outcomes in people with respiratory syncytial virus infection. Findings from this study therefore cannot, on their own, answer whether an intervention prevents or treats RSV infection in a patient population.
The record names several doses and routes, but it does not report a dose-response analysis or enough inferential detail to compare regimens. The observed counts are not a substitute for a prespecified analysis, and the sample-size planning illustrations are not observed power. Missing-data handling and multiplicity procedures are also not reported. The appropriate reading is narrow: the registry contains descriptive safety counts for the listed groups and identifies pharmacokinetic outcomes that were planned or recorded, while leaving important analysis details unavailable.
13. Why This Trial Matters Statistically
This trial is statistically informative as an example of how design and outcome reporting shape interpretation. It is randomized and parallel-group, yet the posted adverse-event group sizes differ substantially. That makes it important to distinguish raw counts from comparative risks and to resist treating count differences as direct evidence of treatment effects. Group-specific denominators are essential context for any safety count.
The endpoint is also a reminder that a safety outcome can be defined in terms of participants rather than events. Those are different units of analysis. A participant count communicates how many people were affected, while event-level data would be needed to describe repeated episodes or detailed event patterns. Separate listings for serious and other adverse events provide useful distinctions, but the registry does not explain overlap or provide a combined primary-endpoint count.
The study has a broad pharmacokinetic focus, including concentration, exposure, elimination, clearance, distribution, and antibody outcomes. This makes clear why a Phase 1 record may address questions beyond a simple treatment-versus-placebo clinical outcome. At the same time, named outcomes without numerical results or methods do not permit independent assessment of estimates or their precision.
Finally, the record illustrates the boundary between design labels and documented analysis. Randomization and masking are stated, but implementation details, statistical methods, multiplicity handling, and missing-data procedures are not reported in the registry record. A transparent statistical interpretation must respect both the information that is recorded and the limits created by information that is absent.
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 does not include a detailed protocol description, randomization method, allocation ratio, or the roles covered by triple masking. Although the study is identified as dose-escalation, the escalation rules and sequence are not reported. The listed arm descriptions specify single fixed doses on Day 1, but do not explain how participants were assigned across dose groups.
The posted safety counts are not accompanied by confidence intervals, p-values, treatment-effect estimates, or a statistical model. The registry lists 0 analyses. It does not provide event-level details for all adverse events, clarify overlap between serious and other events, or give a combined count for the primary endpoint. No numerical pharmacokinetic summaries are included in the record.
The record does not report missing-data methods, outcome-specific completeness, reasons for loss to follow-up, or sensitivity analyses. It also does not report a multiplicity plan. These omissions limit assessment of the precision and robustness of the results. The enrollment figure does not resolve outcome-specific denominators, which are listed separately for adverse events.
The population was healthy adults, so the study record does not directly address outcomes among people with RSV infection. The registry does not report an efficacy endpoint. The serious adverse-event term percentages are listed without group attribution in the information available, limiting their interpretation by regimen. Death counts are not reported in the registry record. These limits concern what can be concluded from the record; they do not imply that the unreported analyses or details were absent from other study documents.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI8897 in Healthy Adults — NCT02114268.
- Registry record last updated 2016-11-28; status last verified 2016-10.
- Results first posted 2016-11-28.
- 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.
Continue through the Clinical Biostats statistical pathway
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18. Record Summary
NCT02114268 is a completed Phase 1 randomized, triple-masked, parallel-group, placebo-controlled dose-escalation study sponsored by MedImmune LLC. The registry records enrollment of 342, a start date of 2014-04, and primary completion in 2015-06. Participants were healthy adults. MEDI8897 was administered as a single fixed dose on Day 1 by intravenous or intramuscular route, with placebo as comparator.
The primary outcome counted participants with TEAEs and TESAEs through Day 391 (Day 361 +/- 30 days). The registry provides group-specific safety counts and lists pharmacokinetic and anti-drug antibody secondary outcomes. It records 0 analyses. Comparative statistical results, missing-data methods, multiplicity procedures, and numerical pharmacokinetic results are not reported in the registry record.