Comparison · NCT04179474-e344e80f
Part 1 (Intervention A Then B Then D) vs Part 2 (Intervention A Then C Then D): Number of Participants Who Had Potentially Clinically Significant (PCS) Postbaseline Vital Sign Values
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. Part 1 (Intervention A Then B Then D) vs Part 2 (Intervention A Then C Then D): Number of Participants Who Had Potentially Clinically Significant (PCS) Postbaseline Vital Sign Values. Trial comparisons, record NCT04179474-e344e80f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04179474-e344e80f
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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 | 0.161 | wilson | |
| Risk in group 2 | 0 | 0 | 0.161 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.161 | 0.161 | 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 | Part 1 (Intervention A Then B Then D) | Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention B: Single subcutaneous (SC) injection of erenumab 140 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions. | 0 | 20 | OG000 |
| Group 2 | Part 2 (Intervention A Then C Then D) | Intervention A: Single oral dose of ubrogepant 100 mg tablet on Day 1 under fasted conditions; followed by Intervention C: Two SC injections of galcanezumab 120 mg on Day 8; followed by Intervention D: Ubrogepant 100 mg tablet orally once daily on Days 12, 13, 14 and 15 under fasted conditions. | 0 | 20 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants Who Had Potentially Clinically Significant (PCS) Postbaseline Vital Sign Values
- Description
Vital Signs included assessments of Blood Pressure, Pulse Rate, Weight, Respiratory Rate and Temperature. The investigator determined if the postbaseline Vital Sign values were potentially clinically significant using the Vital Sign PCS Criteria in the Statistical Analysis Plan (SAP).
- Time frame
- End of Dosing (EOD): Within 7 days of Day 16 or at the time of early termination (Up to Day 16)
- Population
- Safety population included all participants who received/took at least 1 administration of study intervention in Part 1 or Part 2.
Source ClinicalTrials.gov
Trial
- Title
- Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
- NCT number
- NCT04179474
- Phases
- PHASE1
- Conditions
- Migraine
- Interventions
- Ubrogepant, Erenumab, Galcanezumab
- Lead sponsor
- Allergan
- Results first posted
- 2021-03-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04179474?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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