Comparison · NCT01771809-deaths
SHP647 75 mg vs SHP647 225 mg: deaths from any cause
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. SHP647 75 mg vs SHP647 225 mg: deaths from any cause. Trial comparisons, record NCT01771809-deaths. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01771809-deaths
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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 | 0.0061 | 0.00108 | 0.0337 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000173 | 0.0226 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0061 | -0.0171 | 0.0337 | 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 harm, for one more death from any cause on SHP647 75 mg than on SHP647 225 mg | 164 | 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 | SHP647 75 mg | Participants received 75 mg of SHP647 SC injection every 4 weeks for 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. During the first 72 weeks, a one time dose escalation to 225 mg of SHP647 SC injection every 4 weeks was allowed after 8 weeks of the study for participants who experienced clinical deterioration or unacceptably low level of response to the investigational product. The decision to escalate was guided by the response and relapse criteria tempered by clinical judgment. Following the first 72 weeks, participants received 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. | 1 | 164 | EG000 |
| Group 2 | SHP647 225 mg | Participants received 225 mg of SHP647 SC injection every 4 weeks for 72 weeks followed by 75 mg of SHP647 SC injection every 4 weeks for an additional 72 weeks in the anterolateral right/left thigh or the deltoid area or the abdomen. | 0 | 166 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, all-cause mortality
- Time frame
- From start of study drug administration up to 168 weeks
Source ClinicalTrials.gov
Trial
- Title
- Long-Term Safety Of PF-00547659 In Ulcerative Colitis
- NCT number
- NCT01771809
- Phases
- PHASE2
- Conditions
- Ulcerative Colitis
- Interventions
- 75mg SHP647 (PF-00547659), 225mg SHP647 (PF-00547659)
- Lead sponsor
- Shire
- Results first posted
- 2019-04-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01771809?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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