Comparison · NCT00601484-sae
Tanezumab vs Placebo: 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. Tanezumab vs Placebo: serious adverse events. Trial comparisons, record NCT00601484-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00601484-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 | 0.0588 | 0.0163 | 0.191 | wilson | |
| Risk in group 2 | 0.133 | 0.0531 | 0.297 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0745 | -0.243 | 0.0801 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.441 | 0.0869 | 2.24 | log | |
| Odds ratio, group 1 over group 2 | 0.406 | 0.0689 | 2.4 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Tanezumab than on Placebo | 13.4 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Tanezumab | A single dose of tanezumab (RN624 or PF-04383119) 200 microgram per kilogram (mcg/kg) of body weight intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16. | 2 | 34 | EG000 |
| Group 2 | Placebo | A single dose of placebo matched to tanezumab (RN624 or PF-04383119) intravenous infusion over 10 minutes on Day 1. Participants were followed up to Week 16. | 4 | 30 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- An Effectiveness and Safety Study of PF-04383119 for the Treatment of Pain in Interstitial Cystitis
- NCT number
- NCT00601484
- Phases
- PHASE2
- Conditions
- Cystitis, Interstitial
- Interventions
- PF-04383119, Placebo
- Lead sponsor
- Pfizer
- Results first posted
- 2021-05-13
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00601484?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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