Comparison · NCT02135419-sae
Arm I (Treatment) vs Arm II (Active Monitoring) (Closed Since SEP2021): serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Download JSON
Cite this record
ConductScience Library. Arm I (Treatment) vs Arm II (Active Monitoring) (Closed Since SEP2021): serious adverse events. Trial comparisons, record NCT02135419-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02135419-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 | 0.166 | 0.151 | 0.182 | wilson | |
| Risk in group 2 | 0.169 | 0.154 | 0.185 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00285 | -0.0248 | 0.0191 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.983 | 0.862 | 1.12 | log | |
| Odds ratio, group 1 over group 2 | 0.98 | 0.837 | 1.15 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Arm I (Treatment) than on Arm II (Active Monitoring) (Closed Since SEP2021) | 351 | 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 | Arm I (Treatment) | Patients are directed to receive either topical or ablative treatment at the discretion of the clinician. Patients receiving topical treatment apply imiquimod intra-anally, peri-anally or both thrice weekly for up to 16 weeks, fluorouracil twice daily for 5 days every 2 weeks for up to 16 weeks, or trichloroacetic acid every 3 weeks up to 12 weeks. Patients receiving ablative treatment using infrared photocoagulation therapy, hyfrecation/electrocautery (thermal ablation therapy), or laser therapy. Patients may undergo excision under anesthesia if the clinician believes none of the other treatment approaches will be effective. The number and timing of such treatments will be at the discretion of the investigator. Patients with persistent HSIL should continue a protocol-approved treatment or a new protocol treatment should be considered. All participants will have samples collected for laboratory biomarker analysis.~imiquimod: Applied topically~fluorouracil: Applied topically~infrared photocoagulation therapy: Undergo infrared coagulation~thermal ablation therapy: Undergo hyfrecation/electrocautery therapy~laser therapy: Undergo laser therapy~clinical observation: Undergo active monitoring (High Resolution Anoscopy \[HRA\]) with biopsies~laboratory biomarker analysis: Correlative studies | 370 | 2,227 | EG000 |
| Group 2 | Arm II (Active Monitoring) (Closed Since SEP2021) | Patients undergo active monitoring with examinations for clinical observation every 6 months. Every 12 months, patients undergo biopsies of visible lesions. Patients have cytology sampling performed at every visit. All participants will have samples collected for laboratory biomarker analysis.~clinical observation: Undergo active monitoring (High Resolution Anoscopy \[HRA\]) with biopsies~laboratory biomarker analysis: Correlative studies | 375 | 2,219 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected from randomization until up to 5 years after randomization
Source ClinicalTrials.gov
Trial
- Title
- Treatment in Preventing Anal Cancer in Patients With HIV and Anal High-Grade Lesions
- NCT number
- NCT02135419
- Phases
- PHASE3
- Conditions
- Anal Cancer, High-grade Squamous Intraepithelial Lesion, HIV Infection, Human Papilloma Virus Infection
- Interventions
- imiquimod, fluorouracil, infrared photocoagulation therapy, thermal ablation therapy, laser therapy, clinical observation, laboratory biomarker analysis
- Lead sponsor
- AIDS Malignancy Consortium
- Results first posted
- 2022-12-02
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02135419?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/NCT02135419-sae