Comparison · NCT00349622-sae
Ceftriaxone 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. Ceftriaxone vs Placebo: serious adverse events. Trial comparisons, record NCT00349622-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00349622-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 | 0.812 | 0.767 | 0.85 | wilson | |
| Risk in group 2 | 0.723 | 0.652 | 0.784 | wilson | |
| Risk difference, group 1 minus group 2 | 0.0892 | 0.0132 | 0.17 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.12 | 1.01 | 1.25 | log | |
| Odds ratio, group 1 over group 2 | 1.66 | 1.08 | 2.55 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Ceftriaxone than on Placebo | 11.2 | 5.89 | 75.9 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Ceftriaxone | Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day. | 276 | 340 | EG000 |
| Group 2 | Placebo | One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day. | 125 | 173 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Adverse Events were systematically assessed by study investigators at each study visit from the screening visit until 30 days after permanent study drug discontinuation. The total amount of time per subject varies by length of subject participation.
Source ClinicalTrials.gov
Trial
- Title
- Clinical Trial Ceftriaxone in Subjects With ALS
- NCT number
- NCT00349622
- Phases
- PHASE3
- Conditions
- Amyotrophic Lateral Sclerosis, ALS
- Interventions
- ceftriaxone, placebo
- Lead sponsor
- Massachusetts General Hospital
- Results first posted
- 2014-04-01
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00349622?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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