Comparison · NCT02804399-248c390c
PF-06463922 100 mg vs Rifampin 600 mg + PF-06463922 100 mg: Number of Participants With Concomitant Treatments Meeting the Criteria of Potentially Significant Clinical Concerns
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. PF-06463922 100 mg vs Rifampin 600 mg + PF-06463922 100 mg: Number of Participants With Concomitant Treatments Meeting the Criteria of Potentially Significant Clinical Concerns. Trial comparisons, record NCT02804399-248c390c. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02804399-248c390c
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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 | 0.0000000000000000278 | 0.242 | wilson | |
| Risk in group 2 | 0 | 0.0000000000000000278 | 0.242 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.242 | 0.242 | 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 treat | from the risk difference interval | the two groups' risks are equal |
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 | PF-06463922 100 mg | PF-06463922 was administered following an overnight fast of at least 10 hours at approximately 0800 hours (plus or minus 2 hours) as 4 \* 25 milligram (mg) tablets on Day 1 of Period 1. | 0 | 12 | OG000 |
| Group 2 | Rifampin 600 mg + PF-06463922 100 mg | Rifampin 600 mg once daily was administered 1 hour before or 2 hours after a meal from Day 1 to Day 9 of Period 2, except for rifampin dose on Day 8 of Period 2, which was administered simultaneously with PF-06463922. PF-06463922 100 mg (4 \* 25 mg table) and rifampin were administered (rifampin followed by PF-06463922) following an overnight fast of at least 10 hours at approximately 0800 hours (plus or minus 2 hours). | 0 | 12 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Concomitant Treatments Meeting the Criteria of Potentially Significant Clinical Concerns
- Description
Participants abstained from all concomitant treatments, except for the treatment of adverse events. Limited use of non-prescription medications that were not believed to affect participant safety or the overall results of the study might be permitted on a case by case basis following approval by the sponsor. All participants were questioned about concomitant treatment at each clinic visit. Treatments taken within 28 days before the first dose of study investigational product were documented as a prior treatment. Treatment taken after the first dose of study investigational product were documented as concomitant treatments. Females taking hormone replacement therapy might be eligible to participate in this study if they were willing to discontinue therapy at least 28 days prior to the first dose of study treatment and remained off hormonal therapy for duration of the study. Clinical significance was judged by the investigator.
- Time frame
- Baseline to about 18 days after the first PF-06463922 dose.
- Population
- All participants who received PF-06463922, rifampin and PF-06463922 in Period 1 and 2, respectively. A washout period of at least 10 days between the 2 single PF-06463922 dose was maintained.
Source ClinicalTrials.gov
Trial
- Title
- A Study To Evaluate The Effect Of Rifampin On Pharmacokinetics Of PF-06463922 In Healthy Volunteers
- NCT number
- NCT02804399
- Phases
- PHASE1
- Conditions
- Healthy
- Interventions
- PF-06463922, rifampin
- Lead sponsor
- Pfizer
- Results first posted
- 2019-01-25
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT02804399?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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