Atomoxetine vs Placebo: The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.813 | 0.57 | 0.934 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.733 | 0.48 | 0.891 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0792 | -0.21 | 0.36 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.11 | 0.754 | 1.63 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.58 | 0.288 | 8.61 | log | ClinicalTrials.gov | |
| Number needed to treat, for one more participant with the outcome on Atomoxetine than on Placebo | 12.6 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Atomoxetine | Atomoxetine 1.0 to 1.4 mg/kg/day was administered orally once daily in the morning for 16 weeks, during SP II. All eligible participants who received atomoxetine during SP II and completed that period were re-randomized to atomoxetine or placebo in SP III | 13 | 16 | OG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Placebo was packaged in the same way as active comparator to enforce double-blind study design. Placebo was given orally, daily for 16 weeks during SP II. All eligible participants who received placebo during SP II and completed that period were assigned atomoxetine in SP III. | 11 | 15 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | SECONDARY | ClinicalTrials.gov |
| Title | The Number of Participants With Treatment Emergent Adverse Events (TEAE) in Participants With Dyslexia | ClinicalTrials.gov |
| Description | The number of participants who experienced one or more treatment emergent adverse events (TEAEs) and who had Dyslexia A summary of other non-serious adverse events and all serious adverse events, regardless of causality, is located in the Reported Adverse Events Section. | ClinicalTrials.gov |
| Time frame | 16 Weeks | ClinicalTrials.gov |
| Population | All randomized participants who received at least one dose of study drug. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Effects of Atomoxetine on Brain Activation During Attention & Reading Tasks in Participants With ADHD & Comorbid Dyslexia | ClinicalTrials.gov |
| NCT number | NCT00716274 | ClinicalTrials.gov |
| Phases | PHASE4 | ClinicalTrials.gov |
| Conditions | Attention Deficit Hyperactivity Disorder, Dyslexia | ClinicalTrials.gov |
| Interventions | Atomoxetine, Placebo | ClinicalTrials.gov |
| Lead sponsor | Eli Lilly and Company | ClinicalTrials.gov |
| Results first posted | 2018-02-07 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00716274?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.