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 Study of Nivolumab for Advanced Cancers in India (NCT03444766), a na phase 4 study. The primary outcome is Number of Participants With Treatment-related Adverse Events.
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT03444766 |
| Phase | Phase 4 |
| Condition | Non-Small Cell Lung Cancer (NSCLC), Non-Small-Cell Lung Carcinoma, Nonsmall Cell Lung Cancer |
| Allocation | Not applicable (single group) |
| Design model | Single Group |
| Masking | None (open label) |
| Enrollment | 100 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Bristol-Myers Squibb |
| Results posted | Yes |
2. Clinical Question
Population
Participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India. The primary outcome population is described as all treated participants. The registry record does not report further eligibility details, such as disease-specific inclusion criteria or prior-treatment requirements.
Intervention
Nivolumab administered as monotherapy. The arm description specifies nivolumab only; dosing details and other treatment procedures are not reported in the registry record.
Comparator
There is no comparator arm in the single-group design. Allocation is listed as not applicable, so the study does not provide a randomized, concurrent control comparison.
Primary question
Among treated participants, how many experienced treatment-related adverse events, based on the worst CTC grade, within the stated observation period? The endpoint counts participants rather than event episodes. The primary endpoint’s observed count is not reported in the registry record.
This is a safety-focused question about adverse events recorded after nivolumab treatment, not a comparative question about whether nivolumab is better than another treatment. The primary outcome description includes events reported from the first dose through 100 days after the last dose, or for a total of 26 weeks from first on-study treatment, whichever is earliest. This defines the period in which the primary safety outcome is assessed.
The record also lists secondary safety outcomes concerning treatment-related select adverse events, treatment-related serious adverse events, and adverse events leading to discontinuation. Those outcome labels describe additional safety questions, but the registry record does not report their observed results in the registry record for this analysis. The study’s population, treatment, and outcome definition therefore frame a descriptive assessment of safety in the enrolled setting; they do not establish a treatment effect relative to an alternative.
3. Trial Design
The registry record identifies this as a Phase 4 study of nivolumab for selected advanced malignancies in India. It is a single-group design, with a Monotherapy arm described as administering nivolumab only. Allocation is listed as not applicable and masking as none. There is no randomized control group or stated comparator, so the record does not support a like-for-like comparison between treatment strategies.
The listed enrollment is 100. The primary outcome population is all treated participants, and the safety summaries list 100 participants at risk for serious adverse events and 100 at risk in the other adverse-event category. These are the recorded denominators for those safety summaries; they should not be taken as evidence that every enrolled participant was treated or had complete follow-up unless the registry explicitly says so. The treatment and follow-up details beyond the primary outcome window are not reported in the registry record.
The study start date is 2018-03-06, the primary completion date is 2019-07-17, and the status is completed. These dates describe the registered study timeline, not necessarily the timing of every participant’s treatment or outcome assessment.
The primary outcome is the number of participants with treatment-related adverse events during the stated 26 Weeks timeframe, subject to the earlier stopping point described in the outcome definition. The registry lists 4 outcome measures, including secondary safety outcomes, and records 0 analyses. This does not establish whether analyses were performed outside the registry record. Details on the statistical plan, allocation procedures beyond the single-group designation, and sample-size justification are not reported in the registry record.
Because treatment was not compared with a concurrent control, any observed safety counts are descriptive. They can characterize events recorded among participants in this study but cannot separate treatment effects from disease course, other influences, or differences in observation and reporting. No randomized contrast or masking is available to address those sources of uncertainty.
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: 100 participants treated
Overall Study
| Stage | Nivolumab |
|---|---|
| STARTED | 100 |
| COMPLETED | 34 |
| NOT COMPLETED | 66 |
Reasons for not completing this period:
| Reason | Nivolumab |
|---|---|
| Other Reasons | 2 |
| Participant Withdrew Consent | 5 |
| Lost to Follow-up | 2 |
| Death | 2 |
| Adverse Event Unrelated to Study Drug | 6 |
| Disease Progression | 49 |
Analysis population for the primary outcome, as defined in the registry: All treated participants
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Nivolumab |
|---|---|---|
| Participants analysed | 100 | |
| Age, Continuous | Years | 54.7 (SD 10.79) |
| Sex: Female, Male: Female | Participants | 22 |
| Sex: Female, Male: Male | Participants | 78 |
| Ethnicity (NIH/OMB): Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Not Hispanic or Latino | Participants | 0 |
| Ethnicity (NIH/OMB): Unknown or Not Reported | Participants | 100 |
| Race (NIH/OMB): American Indian or Alaska Native | Participants | 0 |
| Race (NIH/OMB): Asian | Participants | 100 |
| Race (NIH/OMB): Native Hawaiian or Other Pacific Islander | Participants | 0 |
| Race (NIH/OMB): Black or African American | Participants | 0 |
| Race (NIH/OMB): White | Participants | 0 |
| Race (NIH/OMB): More than one race | Participants | 0 |
| Race (NIH/OMB): Unknown or Not Reported | Participants | 0 |
6. Primary Endpoint
The registry lists the primary outcome as Number of Participants With Treatment-related Adverse Events, measured over 26 Weeks.
| Element | Registry entry |
|---|---|
| Result type | Number |
| Measure of spread | not applicable |
| Unit | Count of participants |
| Endpoint classification | Binary Endpoint |
The primary endpoint is the number of participants with treatment-related adverse events, reported as a count of participants and assessed according to worst CTC grade. It is not a count of all event episodes. A participant with more than one event is still represented as a participant in this endpoint, rather than as a separate count for every episode. The registry record does not report the observed primary endpoint count.
The observation window begins at the first dose and includes events reported through 100 days after the last dose of nivolumab, or a total of 26 weeks from first on-study treatment, whichever occurs earliest. This rule gives the endpoint a defined period for collecting safety events while limiting the assessment to the earlier of the stated follow-up boundaries.
As a general statistical rationale, participant counts are useful for describing how widely an outcome occurred within a study population. They answer how many participants experienced an event under the endpoint definition, but do not by themselves describe event duration, recurrence, or the total number of episodes. Recording the worst grade can preserve information about maximum reported severity, although the primary endpoint remains a participant count. The registry record does not provide the grade-specific distribution or explain how treatment-relatedness was adjudicated.
The outcome is a safety measure, not an efficacy endpoint. Without a comparator group, the count cannot be interpreted as a comparative treatment effect. The record also does not report an estimate of uncertainty for the primary endpoint.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry record describes a single-group study and lists safety counts, but it does not report the observed count for the primary endpoint, treatment-related adverse events among all treated participants. Consequently, the primary endpoint cannot be numerically interpreted from the record details. Its definition specifies a participant count, the use of worst CTC grade, and an observation window, but those features do not supply the missing result.
Separate adverse-event summaries list 30 participants with serious adverse events among 100 at risk, and 74 participants in the other adverse-event category among 100 at risk. These are participant counts in distinct recorded categories. The record does not explain whether those categories are mutually exclusive, so they should not be added together or treated as a partition of participants. Nor should either figure be substituted for the primary treatment-related adverse-event count: the primary endpoint has its own treatment-related definition, and its observed count is not reported in the registry record.
The serious-event terms listed most prominently include Malignant neoplasm progression at 7.0%, Asthenia at 3.0%, Dyspnoea at 3.0%, Cardiac arrest at 2.0%, Headache at 2.0%, and Pneumonitis at 2.0%. These percentages are attached to listed serious-event terms. The registry record does not clarify in the registry record whether a participant could contribute to more than one term, so the terms should not be summed or treated as independent groups. The separate deaths figure is 17; the record does not state that these deaths were caused by nivolumab or classify them as treatment-related.
There is no randomized comparator, and masking is listed as none. Accordingly, the safety summaries describe recorded events in the study group rather than a contrast with another treatment or with no treatment. They cannot establish what would have occurred to the same participants under an alternative strategy.
The registry records 0 analyses. That entry does not establish that no analyses were conducted outside the registry record, but no inferential results, confidence intervals, or hypothesis tests are reported in the registry record. The posted counts therefore have limited precision information: a count alone does not show the range of values compatible with sampling variability. Any sample-size calculations presented as planning illustrations should be understood as illustrative calculations, not observed power or evidence of a prespecified design target. The study’s own statistical plan and sample-size justification are not reported in the registry record.
9. Statistical Methods Explained
For a binary safety outcome, each participant is classified according to whether the defined event occurred during the assessment window. A participant count reports how many met the endpoint definition; a denominator indicates how many were considered at risk or included in that summary. The primary endpoint is explicitly a count of participants with treatment-related adverse events. The registry does not give its observed count, so no primary-outcome rate or uncertainty interval can be interpreted from the available record.
What does a participant count convey?
A participant count is different from an event count. If a participant experiences repeated events, a participant-based endpoint generally records that participant once for the endpoint, while an event-based analysis may count multiple episodes. The primary outcome wording is participant-based. It also refers to worst CTC grade, which indicates that the most severe recorded grade is relevant to the outcome description. The grade-specific results and details of how event grades or treatment-relatedness were assigned are not reported in the registry record.
As a general statistical explanation, a binary outcome can also be described as a proportion using the number of participants with the event and the relevant denominator. Such a proportion is an estimate for the study population and is subject to sampling variability. A confidence interval expresses the range of values compatible with the observed data under the assumptions of the interval method; it is not a guarantee that the true value lies within that range. No confidence interval for the primary endpoint is reported in the registry record, and no new estimate should be inferred from the counts for other safety categories.
Why does the study design matter?
In a single-group study, observed adverse-event counts describe the participants who received the study treatment and were assessed. They do not form a controlled treatment contrast. General statistical methods for comparing groups rely on information from each group and on assumptions about how participants entered those groups. This record lists no comparator and no random allocation, so a comparative effect estimate is not available from the design information. Descriptive safety findings can still characterize what was recorded, but they cannot identify how much of the observed experience is attributable to treatment rather than other factors.
Masking is listed as none. In general, awareness of treatment can affect reporting, assessment, or decisions about whether an event is treatment-related. The registry entries do not describe procedures to reduce or evaluate those possibilities. The record also does not report details of independent outcome adjudication.
How should the adverse-event categories be read?
The safety record lists serious adverse events and an other adverse-event category, each with its own at-risk denominator and participant count. Those summaries should be read using their own category definitions and denominators. The registry entries do not state whether a participant could be counted in both categories, whether every listed event was treatment-related, or how the other category relates to the primary outcome. As a general principle, counts from categories with possible overlap should not be combined as if they represented different people. The leading serious-event terms and their percentages are term-level summaries, not evidence that terms are mutually exclusive.
What do the analysis and planning entries mean?
The registry record lists 0 analyses. This means no analyses are recorded in that registry entry; it does not show whether other analyses were performed or reported elsewhere. The statistical analysis plan, including any planned model, adjustment strategy, or inferential procedure, is not reported in the registry record. The record also does not report interim analyses or a sample-size justification.
General sample-size calculations can illustrate how many participants per arm might be needed to detect an assumed effect under specified assumptions. In this case, the described planning illustration uses a two-sided significance level of 0.05, equal allocation between two arms, a normal approximation, and an effect defined as a stated fraction of the observed effect. The registry entries also specify that non-time-to-event planning values are participants per arm, while time-to-event calculations give total events. Such planning figures are not observed power and do not establish the study’s original design rationale. The study itself is single-group, so a two-arm illustration does not create a comparator or change the interpretation of its observed safety summaries.
Over-dispersion is a general concern when outcome variation is greater than a statistical model assumes. For binary participant outcomes, dependence or heterogeneity can make a simple model understate uncertainty if not handled appropriately. The registry record does not report a model or an assessment of over-dispersion. This is a general methodological consideration, not a finding about this study.
10. Multiplicity, Missing Data and Analysis Populations
The registry record lists 4 outcome measures: the primary treatment-related adverse-event count and secondary outcomes concerning treatment-related select adverse events, treatment-related serious adverse events, and adverse events leading to discontinuation. Considering several outcomes can raise a multiplicity issue when many statistical tests are performed, because the chance of at least one apparently notable result can increase as testing expands. The record lists 0 analyses and does not report a multiplicity strategy, testing hierarchy, or adjustment. It is therefore not possible to determine from the registry record how any multiple-outcome testing was handled.
Missing-data methods and completeness of outcome follow-up are not reported in the registry record. The primary outcome population is described as all treated participants, but that label alone does not say how participants with incomplete observation, missing event assessments, or early discontinuation were handled. The stated endpoint window allows events through 100 days after the last dose or for 26 weeks from first on-study treatment, whichever is earliest; it does not describe a missing-data procedure.
The record also does not report whether an analysis population different from all treated participants was used for any secondary outcome. It does not state how exposure time, losses to follow-up, or withdrawals were incorporated into the safety summaries. Thus, the at-risk denominators in the adverse-event record should be read as the denominators reported for those summaries, not as proof of complete outcome ascertainment for every participant. Details of the analysis population and missingness handling beyond the primary population label are not reported in the registry record.
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 |
|---|---|---|---|
| Nivolumab | 30 | 100 | 30.0% |
Deaths
| Arm | Deaths (participants affected of at risk) |
|---|---|
| Nivolumab | 17 of 100 |
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 |
|---|---|
| Nivolumab | 74 of 100 |
Most frequent serious adverse event terms
| Event term | Organ system | Nivolumab |
|---|---|---|
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 7 of 100 |
| Asthenia | General disorders | 3 of 100 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 3 of 100 |
| Cardiac arrest | Cardiac disorders | 2 of 100 |
| Headache | Nervous system disorders | 2 of 100 |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | 2 of 100 |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | 2 of 100 |
| Abdominal pain | Gastrointestinal disorders | 1 of 100 |
| Intestinal obstruction | Gastrointestinal disorders | 1 of 100 |
| Pyrexia | General disorders | 1 of 100 |
Most frequent non-serious adverse event terms
| Event term | Organ system | Nivolumab |
|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | 24 of 100 |
| Pyrexia | General disorders | 21 of 100 |
| Vomiting | Gastrointestinal disorders | 17 of 100 |
| Fatigue | General disorders | 16 of 100 |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | 14 of 100 |
| Back pain | Musculoskeletal and connective tissue disorders | 13 of 100 |
| Nausea | Gastrointestinal disorders | 11 of 100 |
| Chest pain | General disorders | 11 of 100 |
| Decreased appetite | Metabolism and nutrition disorders | 11 of 100 |
| Headache | Nervous system disorders | 11 of 100 |
Serious events with the highest arm-level rate: malignant neoplasm progression (7.0%), asthenia (3.0%), dyspnoea (3.0%), cardiac arrest (2.0%), headache (2.0%).
The serious adverse-event summary lists 30 participants with serious adverse events among 100 at risk. The separate other-adverse-event summary lists 74 participants among 100 at risk. These are participant counts, not counts of event episodes. Because the record does not say whether participants can appear in both categories, the counts should not be added or interpreted as separate, non-overlapping groups.
The listed serious-event terms are Malignant neoplasm progression at 7.0%, Asthenia at 3.0%, Dyspnoea at 3.0%, Cardiac arrest at 2.0%, Headache at 2.0%, and Pneumonitis at 2.0%. These term percentages are not a ranking of treatment causality. The registry entries do not state that every serious event was treatment-related, nor do they explain whether a participant could contribute to multiple terms.
The record lists 17 deaths separately. It does not report whether those deaths were related to treatment, whether they were included in the serious-event count, or their causes. The serious-event summaries and death figure therefore describe recorded safety information but do not establish causation. They also do not replace the primary endpoint result, whose observed count is not reported in the registry record.
12. What the Result Does, and Does Not, Mean
The record establishes that this completed, Phase 4 study examined nivolumab monotherapy in participants with advanced Non-Small Cell Lung Cancer or Kidney Cancer in India. It defines a primary safety outcome based on the number of treated participants with treatment-related adverse events, assessed by worst CTC grade over a specified period. These design and outcome details help explain what the study set out to document.
The recorded safety summaries include 30 participants with serious adverse events among 100 at risk, 74 in the other adverse-event category among 100 at risk, and 17 deaths. The serious-event terms and percentages provide additional descriptive detail. However, the observed primary endpoint count is not reported in the registry record. The reported safety figures therefore cannot be used as a substitute for that primary result or assumed to have the same treatment-related definition.
These data do not show that nivolumab caused each event or death. Nor do they show what would have happened under another treatment, because the study has a single group and no comparator. The summaries describe the recorded experience of participants in this study, not a randomized estimate of a treatment effect. Their interpretation is also limited by the absence of reported confidence intervals, analysis details, and missing-data procedures in the registry record.
In general, safety counts can be informative about events observed during a defined study period, while still leaving uncertainty about how precisely they represent a broader population. A count is not a complete account of event severity, duration, recurrence, or attribution. The registry record’s definitions and denominators should be kept alongside the figures, and unreported details should not be inferred. The study record supports a descriptive reading of the safety information, not a conclusion about comparative benefit or harm.
13. Why This Trial Matters Statistically
This trial matters statistically because its design makes the distinction between description and comparison especially important. A single-group safety study can document adverse events observed during treatment and follow-up. Without a concurrent comparator, however, it cannot estimate a treatment contrast against another strategy. That limitation is structural to the design, not a question resolved by interpreting the event counts more strongly.
The outcome definitions also matter. The primary endpoint counts participants with treatment-related adverse events and uses worst CTC grade, while the separate safety summaries report serious events and an other-event category. These are not automatically interchangeable measures. The primary endpoint’s observed count is not reported in the registry record, so the available safety summaries should not be presented as if they posted that missing result.
The denominators and potential overlap deserve attention as well. The serious and other categories each have 100 participants at risk, but the record does not say whether participants can contribute to both. Treating the categories as disjoint or combining their counts would require information that is not reported. Likewise, the listed serious-event terms may overlap at the participant level.
Finally, the registry records 0 analyses and does not report a statistical plan, missing-data methods, or multiplicity handling. Those omissions limit assessment of how uncertainty and multiple outcomes were addressed. A planning illustration based on assumed two-arm comparisons can be useful as a general design calculation, but it is not the design of this single-group study and is not observed power. Reading these distinctions carefully prevents descriptive safety information from being overstated as causal or comparative evidence.
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.
Several trial-specific limitations affect interpretation. The study is single-group, with allocation listed as not applicable and masking as none. There is no comparator for assessing whether observed events differ from those under another treatment or from the background experience of a similar population. The design therefore supports description of recorded safety events but not a controlled estimate of treatment effect.
The primary endpoint’s observed count is not reported in the registry record. Although its population, event definition, grade basis, and observation window are described, the primary result itself cannot be assessed from these registry entries. The separate serious and other adverse-event summaries do not resolve that gap because their relationship to the primary treatment-related endpoint is not specified.
The registry record does not explain whether the serious and other categories overlap, how treatment-relatedness was determined, or whether the serious-event terms can overlap at the participant level. The 17 deaths are not classified by cause or treatment relationship in the registry record. These uncertainties restrict interpretation of the safety counts and term percentages.
Further limitations are that the statistical plan, sample-size justification, confidence intervals, missing-data procedures, multiplicity handling, and details of outcome adjudication are not reported in the registry record. The primary population is described as all treated participants, but the record does not describe follow-up completeness or the handling of incomplete assessments. These gaps prevent a full evaluation of precision, bias, or the robustness of the analysis.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Study of Nivolumab for Advanced Cancers in India — NCT03444766.
- Registry record last updated 2020-12-04; status last verified 2020-12.
- Results first posted 2020-12-04.
- 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
The registry record describes a completed Phase 4, single-group study of nivolumab monotherapy for advanced Non-Small Cell Lung Cancer or Kidney Cancer in India. Listed enrollment is 100. The study started on 2018-03-06 and reached primary completion on 2019-07-17. Masking is listed as none, and no comparator arm is described.
The primary endpoint is the number of treated participants with treatment-related adverse events, based on worst CTC grade, during the stated 26 Weeks observation period with the earlier stopping boundary described in the outcome definition. Its observed count is not reported in the registry record. Safety summaries list 30 participants with serious adverse events and 74 in the other adverse-event category, each among 100 at risk, as well as 17 deaths. The record does not establish overlap between categories or treatment causality for deaths.
The registry lists 4 outcome measures and 0 analyses. Statistical methods, missing-data handling, multiplicity procedures, and sample-size justification are not reported in the registry record.