Comparison · NCT04839354-sae
L-Arginine Hydrochloride 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
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ConductScience Library. L-Arginine Hydrochloride vs Placebo: serious adverse events. Trial comparisons, record NCT04839354-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04839354-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 | 0.171 | 0.115 | 0.245 | wilson | |
| Risk in group 2 | 0.176 | 0.122 | 0.247 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00551 | -0.0954 | 0.0862 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.969 | 0.575 | 1.63 | log | |
| Odds ratio, group 1 over group 2 | 0.962 | 0.512 | 1.81 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on L-Arginine Hydrochloride than on Placebo | 181 | 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 | L-Arginine Hydrochloride | Participants receiving L-arginine hydrochloride in parenteral form. Participants receive up to 21 doses, with participants who are discharged early receiving fewer doses. A one-time L-arginine hydrochloride loading dose of 200 mg/kg is administered intravenously (IV) followed by a standard dose of 100 mg/kg given by IV three times per day (TID). | 22 | 129 | EG000 |
| Group 2 | Placebo | Participants receiving normal saline as a placebo for L-arginine hydrochloride for up to 21 doses, with participants who are discharged early receiving fewer doses. A placebo of normal saline is administered by IV with a loading dose of 2ml/kg followed by 1ml/kg given by IV three times per day (TID). | 25 | 142 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Information on adverse events was collected beginning at the time of randomization through Day 9 or hospital discharge or emergency department discharge (whichever comes first, up to 9 days). Emergency department revisits and hospital admissions were tracked through 28 days following hospital or emergency discharge and entered as adverse events or serious adverse events (up to 583 days).
Source ClinicalTrials.gov
Trial
- Title
- Sickle Cell Disease Treatment With Arginine Therapy (STArT) Trial
- NCT number
- NCT04839354
- Phases
- PHASE3
- Conditions
- Sickle Cell Disease
- Interventions
- L-Arginine Hydrochloride, Normal saline
- Lead sponsor
- Claudia R. Morris
- Results first posted
- 2025-07-30
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04839354?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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