Comparison · NCT01081132-sae
SPD503 vs PLACEBO: 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. SPD503 vs PLACEBO: serious adverse events. Trial comparisons, record NCT01081132-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01081132-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 | 0.0255 | 0.00995 | 0.0637 | wilson | |
| Risk in group 2 | 0.0129 | 0.00355 | 0.0458 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0126 | -0.0238 | 0.0519 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.97 | 0.367 | 10.6 | log | |
| Odds ratio, group 1 over group 2 | 2 | 0.361 | 11.1 | log | |
| Number needed to harm, for one more participant with a serious adverse event on SPD503 than on PLACEBO | 79.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | SPD503 | Orally administered a once-daily optimal dose between 0.05 mg/kg/day - 0.12 mg/kg/day (up to 7 mg/day depending on weight). | 4 | 157 | EG001 |
| Group 2 | PLACEBO | Orally administered a once-daily dose | 2 | 155 | EG000 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Dose-optimization in Adolescents Aged 13-17 Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD) Using Extended-release Guanfacine HCl
- NCT number
- NCT01081132
- Phases
- PHASE3
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Interventions
- Extended-release Guanfacine Hydrochloride, Placebo
- Lead sponsor
- Shire
- Results first posted
- 2014-05-23
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01081132?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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