Comparison · NCT01402908-sae
PI-88 vs Placebo: 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. PI-88 vs Placebo: serious adverse events. Trial comparisons, record NCT01402908-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01402908-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 | 0.116 | 0.0827 | 0.161 | wilson | |
| Risk in group 2 | 0.0577 | 0.0353 | 0.093 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0586 | 0.00985 | 0.109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.02 | 1.11 | 3.66 | log | |
| Odds ratio, group 1 over group 2 | 2.15 | 1.13 | 4.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on PI-88 than on Placebo | 17.1 | 9.2 | 102 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | PI-88 | Arm 1~PI-88: Lyophilized powder reconstituted to provide 160 mg of PI-88~In the safety population, the subjects were analyzed according to the actual treatment received and must have received at least one dose of study medication.~A total of 258 subjects were included in the safety population. | 30 | 258 | EG000 |
| Group 2 | Placebo | Arm 2~Placebo: Lactose lyophilized powder~In the safety population, the subjects were analyzed according to the actual treatment received and must have received at least one dose of study medication.~Because one subject withdrew the consent before treatment, a total of 260 subjects were included in the safety population. | 15 | 260 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
The adverse events were collected at each study visit during the study period (3 year). In the safety population, the subjects were analyzed according to the actual treatment received and must have received at least one dose of study medication.
Source ClinicalTrials.gov
Trial
- Title
- A Phase III PI-88 in the Adjuvant Treatment of Subjects With Hepatitis Virus Related HCC After Surgical Resection
- NCT number
- NCT01402908
- Phases
- PHASE3
- Conditions
- Cancer, Liver Cancer, Hepatocellular Carcinoma
- Interventions
- PI-88, Placebo
- Lead sponsor
- Cellxpert Biotechnology Corp.
- Results first posted
- 2020-12-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01402908?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/NCT01402908-sae