Comparison · NCT01179217-sae
L-glutamine vs 100% Maltodextrin: 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. L-glutamine vs 100% Maltodextrin: serious adverse events. Trial comparisons, record NCT01179217-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01179217-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 | 0.781 | 0.709 | 0.84 | wilson | |
| Risk in group 2 | 0.872 | 0.78 | 0.929 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0903 | -0.183 | 0.0186 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.896 | 0.795 | 1.01 | log | |
| Odds ratio, group 1 over group 2 | 0.526 | 0.244 | 1.13 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on L-glutamine than on 100% Maltodextrin | 11.1 | from the risk difference interval | the interval includes no difference |
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 | L-glutamine | Patients will be randomized to receive investigational product, L-Glutamine.~L-glutamine: 0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended. | 118 | 151 | EG000 |
| Group 2 | 100% Maltodextrin | Patients will be randomized to receive Placebo.~100% maltodextrin: 0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. | 68 | 78 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events data were collected throughout the course of the study (53 weeks or about 1 year).
Source ClinicalTrials.gov
Trial
- Title
- A Phase III Safety and Efficacy Study of L-Glutamine to Treat Sickle Cell Disease or Sickle βo-thalassemia
- NCT number
- NCT01179217
- Phases
- PHASE3
- Conditions
- Sickle Cell Anemia, Sickle ß0-Thalassemia
- Interventions
- L-glutamine, Placebo
- Lead sponsor
- Emmaus Medical, Inc.
- Results first posted
- 2017-08-10
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01179217?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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