Comparison · NCT01856270-sae
Amitriptyline Immediate vs Amitriptyline Delayed: serious adverse events
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. Amitriptyline Immediate vs Amitriptyline Delayed: serious adverse events. Trial comparisons, record NCT01856270-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01856270-sae
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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 | 0.0000000000000000139 | 0.138 | wilson | |
| Risk in group 2 | 0 | 0 | 0.129 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.129 | 0.138 | 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 | 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 | Amitriptyline Immediate | The Immediate group will begin study drug immediately after enrollment. Immediate Drug participants will be started on one 10 mg capsule each evening. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3. | 0 | 24 | EG000 |
| Group 2 | Amitriptyline Delayed | The Delayed group will start the study drug at the Day 30 visit on one 10 mg capsule each evening to assess whether there is any cognitive impact of the medication (comparing to those who started immediately after enrollment. The dosage will be adjusted upwards to 25 mg daily for Week 2 to a maximum of 50 mg daily by Week 3. | 0 | 26 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected throughout the duration of medication usage at baseline, then at day 30, day 60, and at day 90 when medication was discontinued.
Source ClinicalTrials.gov
Trial
- Title
- Amitriptyline to Prevent Headache After Traumatic Brain Injury
- NCT number
- NCT01856270
- Phases
- PHASE2
- Conditions
- Brain Injuries, Post-Traumatic Headache
- Interventions
- Amitriptyline
- Lead sponsor
- University of Washington
- Results first posted
- 2017-12-22
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01856270?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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