Comparison · NCT01890109-64feca6b
Erenumab vs Placebo: Number of Participants With Treatment-emergent Suicidal Ideation
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. Erenumab vs Placebo: Number of Participants With Treatment-emergent Suicidal Ideation. Trial comparisons, record NCT01890109-64feca6b. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01890109-64feca6b
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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 | 0.00000000000000000694 | 0.0713 | wilson | |
| Risk in group 2 | 0 | 0 | 0.0688 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0688 | 0.0713 | 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
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Erenumab | Participants received a single dose of 70 mg erenumab administered by subcutaneous injection. | 0 | 50 | OG001 |
| Group 2 | Placebo | Participants received a single dose of placebo administered by subcutaneous injection. | 0 | 52 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Suicidal Ideation
- Description
The Columbia Suicide Severity Rating Scale (C-SSRS) was used to assess suicidal ideation during the study based on the following Yes/No questions:~1. Have you wished you were dead or wished you could go to sleep and not wake up?~2. Have you actually had any thoughts of killing yourself?
- Time frame
- 16 weeks
- Population
- All participants who received study drug
Source ClinicalTrials.gov
Trial
- Title
- Study of Erenumab (AMG 334) in Women With Hot Flashes
- NCT number
- NCT01890109
- Phases
- PHASE1
- Conditions
- Vasomotor Symptoms; Hot Flashes
- Interventions
- Erenumab, Placebo
- Lead sponsor
- Amgen
- Results first posted
- 2019-01-14
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01890109?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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