Comparison · NCT00605865-24f8d825
With Concomitant Drug vs Without Concomitant Drug: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug
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 Concomitant Drug vs Without Concomitant Drug: Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug. Trial comparisons, record NCT00605865-24f8d825. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00605865-24f8d825
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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 | 0.128 | 0.113 | 0.144 | wilson | |
| Risk in group 2 | 0.0853 | 0.0585 | 0.123 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0424 | 0.0021 | 0.0736 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.5 | 1.01 | 2.22 | log | |
| Odds ratio, group 1 over group 2 | 1.57 | 1.02 | 2.42 | log | |
| Number needed to treat, for one more participant with the outcome on With Concomitant Drug than on Without Concomitant Drug | 23.6 | 13.6 | 476 | 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 Concomitant Drug | Participants with concomitant drug who took Sertraline according to Japanese Package Insert | 238 | 1,864 | OG000 |
| Group 2 | Without Concomitant Drug | Participants without concomitant drug who took Sertraline according to Japanese Package Insert | 25 | 293 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Sertraline: Concomitant Drug
- Description
Number of participants with Treatment Related Adverse Events (TRAEs) of Sertraline to determine whether with or without concomitant drug is significant risk factor, Concomitant drugs is the drugs which participant had taken during the observation period of this study to treat for participant's illnesses, injuries etc. The physician of this survey listed all of concomitant drugs. (e.g. paroxetine, milnacipran, etc.)
- 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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