Comparison · NCT06476366-sae
Methotrexate Arm vs Azathioprine: 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. Methotrexate Arm vs Azathioprine: serious adverse events. Trial comparisons, record NCT06476366-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT06476366-sae
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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 | 0.1 | 0.0179 | 0.404 | wilson | |
| Risk in group 2 | 0 | 0 | 0.278 | wilson | |
| Risk difference, group 1 minus group 2 | 0.1 | -0.189 | 0.404 | 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 Methotrexate Arm than on Azathioprine | 10 | 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 | Methotrexate Arm | After the enrollment of patients and taking consent, participants will be divided in two treatment groups via lottery method. Group A will be administered oral methotrexate 10mg/week after a test dose | 1 | 10 | EG000 |
| Group 2 | Azathioprine | group B will be administered tablet azathioprine at a dose of 0.3mg/kg daily after. Both group of patients will be advised regarding strict sun protection measures (sunblock, hats, sunglasses etc.). The baseline investigations for both groups will include complete blood picture (CBC), liver function tests (LFTs), renal function tests (RFTs), electrocardiogram, chest X-ray and urine analysis while thiopurine methyltransferase (TPMT) levels will be assessed specifically for group B patients. The patients will be followed up at week 4, 12 and 24. CBC, RFTs and LFTs will be done at each follow-up and EASI score will be calculated, | 0 | 10 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- From enrollment to end of followup, upto 24 weeks
Source ClinicalTrials.gov
Trial
- Title
- Comparison of Efficacy of Methotrexate and Azathioprine in Patients With Chronic Actinic Dermatitis: A Randomized Controlled Trial
- NCT number
- NCT06476366
- Phases
- EARLY_PHASE1
- Conditions
- Chronic Actinic Dermatitis
- Interventions
- Azathioprine, Methotrexate
- Lead sponsor
- Pak Emirates Military Hospital
- Results first posted
- 2025-08-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT06476366?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.
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