Comparison · NCT03740997-sae
Body Weight Group <=40 kg: OPTISON vs Body Weight Group >40 kg: OPTISON: 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. Body Weight Group <=40 kg: OPTISON vs Body Weight Group >40 kg: OPTISON: serious adverse events. Trial comparisons, record NCT03740997-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03740997-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 | 0 | 0.324 | wilson | |
| Risk in group 2 | 0 | 0 | 0.117 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.117 | 0.324 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
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 | Body Weight Group <=40 kg: OPTISON | Participants with body weight \>=20 to \<=28 kg received OPTISON 0.1 mL (dose level 1) or 0.2 mL (dose level 2); and participants with body weight \>28 to \<=40 kg received OPTISON 0.2 mL (dose level 1) or 0.3 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose for body weight \>=20 to \<=28 kg and \>28 to \<=40 kg was 1.0 mL and 1.5 mL per dose level, respectively.~All subjects were imaged without contrast then with dose level 1 and then dose level 2. So it is impossible to separate the AE for each intervention. | 0 | 8 | EG000 |
| Group 2 | Body Weight Group >40 kg: OPTISON | Participants with body weight \>40 kg received OPTISON 0.2 (dose level 1) or 0.4 mL (dose level 2) IV injection, 10 minutes apart on Day 1. The maximum allowed cumulative dose was 1.8 mL per dose level.~All subjects were imaged without contrast then with dose level 1 and then dose level 2. So it is impossible to separate the AE for each intervention. | 0 | 29 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- 0- 72 hours
Source ClinicalTrials.gov
Trial
- Title
- Study to Determine Safety and Dosage of OPTISON in Pediatric Participants
- NCT number
- NCT03740997
- Phases
- PHASE4
- Conditions
- Transthoracic Echocardiography, Suspected or Known Structural or Functional Cardiac Abnormality
- Interventions
- Optison
- Lead sponsor
- GE Healthcare
- Results first posted
- 2024-05-17
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03740997?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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