Comparison · NCT03077451-sae
High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) vs Standard Dose Treatment (Nelfinavir Mesylate): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) vs Standard Dose Treatment (Nelfinavir Mesylate): serious adverse events. Trial comparisons, record NCT03077451-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03077451-sae
On this page
Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0323 | 0.00572 | 0.162 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0964 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0323 | -0.0677 | 0.162 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
Number needed to harm, for one more participant with a serious adverse event on High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) than on Standard Dose Treatment (Nelfinavir Mesylate) | 31 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | High Dose Treatment After Receiving the Standard Dose (Nelfinavir Mesylate) | This study is not parallel arm study. Nelfinavir dose will be administrated in the sequential manner according to the response.~AE summary is based on participants who received high dose. There were totally 31 participants received high dose after receiving standard dose.~All patients will received standard dose of nelfinavir (1250 mg BID) for at least 4 weeks. If after 4 weeks there is progressive disease (PD), the participant will advance to the high dose nelfinavir (3125 mg BID). If by 8 weeks there is stable disease (SD) or partial response (PR) at the standard dose, the participant will advance to high dose of nelfinavir.~The high dose nelfinavir treatment will be continued for at least 4 weeks. If there is progressive disease (PD) documented after 4 weeks at the high dose level, nelfinavir will be discontinued. If there is stable disease (SD) or partial response (PR) at the high dose level, high dose nelfinavir will be continued for up to 16 weeks. If there is a complete response (CR), high dose treatment will be discontinued 4 weeks after documentation of complete response. | 1 | 31 | EG000 |
| Group 2 | Standard Dose Treatment (Nelfinavir Mesylate) | This study is not parallel arm study. Nelfinavir dose will be administrated in the sequential manner according to the response.~AE summary is based on participants who received standard dose. There were totally 36 participants received standard dose initally.~All patients will received standard dose of nelfinavir (1250 mg BID) for at least 4 weeks. If there is complete response (CR) at any time at the standard dose, nelfinavir will be discontinued 4 weeks after documentation of CR. | 0 | 36 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 8 weeks (4 weeks for standard dose and 4 weeks for high dose);
Source ClinicalTrials.gov
Trial
- Title
- Nelfinavir Mesylate in Treating Patients With Kaposi Sarcoma
- NCT number
- NCT03077451
- Phases
- PHASE2
- Conditions
- Recurrent Kaposi Sarcoma, Skin Kaposi Sarcoma
- Interventions
- Laboratory Biomarker Analysis, Nelfinavir Mesylate
- Lead sponsor
- AIDS Malignancy Consortium
- Results first posted
- 2024-02-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03077451?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03077451-sae