Comparison · NCT00791492-e453f76f
Tafamidis-Tafamidis vs Placebo-Tafamidis: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
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. Tafamidis-Tafamidis vs Placebo-Tafamidis: Number of Participants With Treatment-emergent Serious Adverse Events (SAEs). Trial comparisons, record NCT00791492-e453f76f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00791492-e453f76f
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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 | 0.114 | 0.0495 | 0.24 | wilson | |
| Risk in group 2 | 0.0976 | 0.0386 | 0.225 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0161 | -0.127 | 0.155 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.16 | 0.336 | 4.04 | log | |
| Odds ratio, group 1 over group 2 | 1.19 | 0.295 | 4.76 | log | |
| Number needed to treat, for one more participant with the outcome on Tafamidis-Tafamidis than on Placebo-Tafamidis | 62.2 | 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 | Tafamidis-Tafamidis | Participants who received tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months. | 5 | 44 | OG000 |
| Group 2 | Placebo-Tafamidis | Participants who received placebo matched to tafamidis (Fx-1006A) 20 mg capsule orally once daily for 18 months during previous study FX-005 (NCT00409175), received tafamidis (Fx-1006A) 20 mg capsule orally once daily for 12 months. | 4 | 41 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Treatment-emergent Serious Adverse Events (SAEs)
- Description
An Adverse Event (AE) was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. SAE: AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent/significant disability/incapacity; congenital anomaly. Treatment-emergent were events between first dose of study drug, up to 30 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
- Time frame
- Baseline up to 30 days after last dose of study medication
- Population
- Safety population included participants who received at least one dose of study medication.
Source ClinicalTrials.gov
Trial
- Title
- An Extension of Study Fx-005 Evaluating Long-Term Safety And Clinical Outcomes Of Fx-1006A In Patients With Transthyretin Amyloid Polyneuropathy
- NCT number
- NCT00791492
- Phases
- PHASE2, PHASE3
- Conditions
- Familial Amyloid Polyneuropathy, ATTR-PN
- Interventions
- Fx-1006A
- Lead sponsor
- Pfizer
- Results first posted
- 2012-12-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00791492?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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