Comparison · NCT04104646-sae
CHF6563 vs Morphine: 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. CHF6563 vs Morphine: serious adverse events. Trial comparisons, record NCT04104646-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04104646-sae
On this page
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 | 0.434 | wilson | |
| Risk in group 2 | 0 | 0 | 0.658 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.658 | 0.434 | 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 | CHF6563 | Sublingual dose of CHF6563 and the corresponding oral dose of morphine matched placebo~CHF6563: Sublingual CHF6563 administration at starting dose of 10 µg/kg q8~Morphine matched-placebo: Oral morphine-matched placebo administration | 0 | 5 | EG000 |
| Group 2 | Morphine | Oral dose of morphine and the corresponding sublingual dose of CHF6563 matched placebo.~Morphine: Oral morphine administration at starting dose of 0.07 mg/kg q4~CHF6563 matched-placebo: Sublingual CHF6563 matched-placebo administration | 0 | 2 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
AEs and serious AEs (SAEs) were collected from the time of informed consent signature or from the neonate's birth through treatment and follow-up (FU) period (48 h after last treatment). Daily phone calls with the primary caregiver was for the first 7 d; weekly phone contact was up to 6 weeks after the final opioid treatment dose. NOWS treatment duration depends on Finnegan Neonatal Abstinence Scoring Tool (FNAST) scores and differs for each neonate; the maximum length of treatment was 10 weeks.
Source ClinicalTrials.gov
Trial
- Title
- CHF6563 in Babies With Neonatal Opioid Withdrawal Syndrome
- NCT number
- NCT04104646
- Phases
- PHASE2
- Conditions
- Neonatal Opioid Withdrawal Syndrome
- Interventions
- CHF6563, Morphine, CHF6563 matched placebo, Morphine matched placebo
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Results first posted
- 2023-08-03
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT04104646?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT04104646-sae