Comparison · NCT00605865-620a9583
With Renal Dysfunction vs Without Renal Dysfunction: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction
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. With Renal Dysfunction vs Without Renal Dysfunction: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction. Trial comparisons, record NCT00605865-620a9583. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00605865-620a9583
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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 | 0.292 | 0.149 | 0.492 | wilson | |
| Risk in group 2 | 0.12 | 0.107 | 0.134 | wilson | |
| Risk difference, group 1 minus group 2 | 0.172 | 0.0284 | 0.372 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 2.43 | 1.29 | 4.58 | log | |
| Odds ratio, group 1 over group 2 | 3.02 | 1.24 | 7.35 | log | |
| Number needed to treat, for one more participant with the outcome on With Renal Dysfunction than on Without Renal Dysfunction | 5.83 | 2.69 | 35.2 | from the risk difference interval |
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 | With Renal Dysfunction | Participants with renal dysfunction who took Sertraline according to Japanese Package Insert | 7 | 24 | OG000 |
| Group 2 | Without Renal Dysfunction | Participants without renal dysfunction who took Sertraline according to Japanese Package Insert | 256 | 2,133 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Renal Dysfunction
- Description
- Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without renal dysfunction is significant risk factor
- Time frame
- Baseline up to 16 weeks
- Population
- The safety analysis population consists of the cases that satisfy the participant's conditions and in whom administration of Sertraline was confirmed.
Source ClinicalTrials.gov
Trial
- Title
- Drug Use Investigation of Jzoloft.
- NCT number
- NCT00605865
- Phases
- Conditions
- Panic Disorder, Depression
- Interventions
- Sertraline hydrochloride
- Lead sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
- Results first posted
- 2012-10-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00605865?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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