Comparison · NCT03740997-ea897940
Body Weight Group <=40 kg: OPTISON vs Body Weight Group >40 kg: OPTISON: Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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. Body Weight Group <=40 kg: OPTISON vs Body Weight Group >40 kg: OPTISON: Number of Participants With Treatment-emergent Adverse Events (TEAEs). Trial comparisons, record NCT03740997-ea897940. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03740997-ea897940
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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 | 0.5 | 0.215 | 0.785 | wilson | |
| Risk in group 2 | 0.31 | 0.173 | 0.492 | wilson | |
| Risk difference, group 1 minus group 2 | 0.19 | -0.148 | 0.506 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.61 | 0.668 | 3.88 | log | |
| Odds ratio, group 1 over group 2 | 2.22 | 0.452 | 10.9 | log | |
| Number needed to treat, for one more participant with the outcome on Body Weight Group <=40 kg: OPTISON than on Body Weight Group >40 kg: OPTISON | 5.27 | 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 | 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. | 4 | 8 | OG000 |
| 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. | 9 | 29 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment-emergent Adverse Events (TEAEs)
- Description
An Adverse Event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily had to have causal relationship with treatment. TEAEs were defined as AEs that starts or worsens at or after the time of first dosing of OPTISON.
- Time frame
- 0- 72 hours
- Population
- The Safety population consisted of all enrolled participants who received \>=1 dose of OPTISON in the study.
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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