Comparison · NCT00742508-sae
CRV-IR vs SK&F-105517-D: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Download JSON
Cite this record
ConductScience Library. CRV-IR vs SK&F-105517-D: serious adverse events. Trial comparisons, record NCT00742508-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00742508-sae
On this page
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 | 0.0455 | 0.00807 | 0.218 | wilson | |
| Risk in group 2 | 0.158 | 0.0552 | 0.376 | wilson | |
| Risk difference, group 1 minus group 2 | -0.112 | -0.333 | 0.0883 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.288 | 0.0326 | 2.54 | log | |
| Odds ratio, group 1 over group 2 | 0.254 | 0.0241 | 2.68 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on CRV-IR than on SK&F-105517-D | 8.89 | from the risk difference interval | the interval includes no difference |
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 | CRV-IR | In the 8-week Primary Evaluation Period (including the 2-week Run-in Period \[from Week 0 as Baseline\]), participants received an initial dose of an immediate-release (IR) formulation of carvedilol (CRV) as a 1.25 milligram (mg) tablet twice daily (BID) (2.5 mg/day) at Week 0, followed by an increased dose of CRV-IR 2.5 mg tablet BID (5 mg/day) at Week 1. The dose was then increased to 5 mg BID (10 mg/day) at Week 4, and finally to 10 mg BID (20 mg/day) at Week 6. The participants on CRV-IR were switched to the marketed CRV-IR in Week 1 of the Follow-up Period; the investigator or subinvestigator determined the dose of the marketed CRV-IR based on the last dose administered during the Primary Evaluation Period after confirming the safety and tolerability of the dose. | 1 | 22 | EG000 |
| Group 2 | SK&F-105517-D | In the 8-week Primary Evaluation Period (including the 2-week Run-in Period \[from Week 0 as Baseline\]), participants received a CRV-IR 1.25 mg and 2.5 mg tablet BID at Weeks 0 and 1, respectively. They then received a 10 mg extended-release capsule of carvedilol (SK\&F-105517-D) once daily (OD) at Week 2; the dose was then increased to 20 mg OD and finally to 40 mg OD at 2-week intervals. The dose was increased from 40 mg to 60 mg and finally to 80 mg at 2-week intervals in the 4-week Exploratory Evaluation Period after confirming that each dose was well tolerated without safety concern and that the participant met all of the dose-escalation criteria. During the 2-week Dose-tapering Period set up to prepare for switch to the marketed CRV-IR, the dose of SK\&F-105517-D was reduced to 60 mg OD and then to 40 mg OD at weekly intervals; SK\&F-105517-D was then switched to the marketed CRV-IR 10 mg tablet BID in the 1-week Follow-up Period. | 3 | 19 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Treatment Period from Week 0 (Baseline) to Week 8 and 1-week Follow-up Period (Week 9) for CRV-IR; Treatment Period from Week 0 (Baseline) to Week 14 and 1-week Follow-up Period (Week 15) for SK&F-105517-D.
Source ClinicalTrials.gov
Trial
- Title
- A Phase I/II Clinical Study of SK&F-105517-D in Japanese Patients With Chronic Heart Failure
- NCT number
- NCT00742508
- Phases
- PHASE1
- Conditions
- Heart Failure, Congestive
- Interventions
- SK&F-105517-D 10 mg capsule, Carvedilol-immediate release (IR) 2.5 mg tablet, SK&F-105517-D 20 mg capsule, SK&F-105517-D 40 mg capsule, Carvedilol-IR 10 mg tablet
- Lead sponsor
- GlaxoSmithKline
- Results first posted
- 2010-08-19
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00742508?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT00742508-sae