Comparison · NCT01341782-sae
Paricalcitol vs Maxacalcitol: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. Paricalcitol vs Maxacalcitol: serious adverse events. Trial comparisons, record NCT01341782-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01341782-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 | 0.0787 | 0.0433 | 0.139 | wilson | |
| Risk in group 2 | 0.117 | 0.0723 | 0.184 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0384 | -0.114 | 0.0366 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.672 | 0.314 | 1.44 | log | |
| Odds ratio, group 1 over group 2 | 0.644 | 0.278 | 1.49 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Paricalcitol than on Maxacalcitol | 26 | 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 | Paricalcitol | Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg. | 10 | 127 | EG000 |
| Group 2 | Maxacalcitol | Participants received maxacalcitol at an initial dose of 5 µg (iPTH \< 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg. | 15 | 128 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
- NCT number
- NCT01341782
- Phases
- PHASE3
- Conditions
- Secondary Hyperparathyroidism, Hemodialysis
- Interventions
- paricalcitol, maxacalcitol, paricalcitol placebo, maxacalcitol placebo
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Results first posted
- 2013-06-06
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01341782?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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