IPLEX™ vs Placebo: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.206 | 0.103 | 0.368 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.171 | 0.081 | 0.327 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | 0.0345 | -0.152 | 0.22 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 1.2 | 0.449 | 3.21 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 1.25 | 0.374 | 4.2 | log | ClinicalTrials.gov | |
| Number needed to harm, for one more participant with a serious adverse event on IPLEX™ than on Placebo | 29 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | IPLEX™ | Participants received 1.0 mg/kg IPLEX™ (rhIGF-I/rhIGFBP-3) via a subcutaneous injection once a day for 24 weeks. | 7 | 34 | EG000 | ClinicalTrials.gov |
| Group 2 | Placebo | Participants received a matching placebo to IPLEX™ once a day via a subcutaneous injection for 24 weeks. | 6 | 35 | EG001 | ClinicalTrials.gov |
Harm 2
| Field | Value | Source |
|---|---|---|
| What it counts | Total, serious adverse events | ClinicalTrials.gov |
| Time frame | 28 weeks | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Safety and Efficacy Study of Recombinant Human Insulin-Like Growth Factor-I/Recombinant Human Insulin-Like Growth Factor Binding Protein-3 (rhIGF-I/rhIGFBP-3) In Myotonic Dystrophy Type 1 | ClinicalTrials.gov |
| NCT number | NCT00577577 | ClinicalTrials.gov |
| Phases | PHASE2 | ClinicalTrials.gov |
| Conditions | Myotonic Dystrophy Type 1 | ClinicalTrials.gov |
| Interventions | rhIGF-I/rhIGFBP-3, placebo | ClinicalTrials.gov |
| Lead sponsor | Insmed Incorporated | ClinicalTrials.gov |
| Results first posted | 2022-01-06 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00577577?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| 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 | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.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.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.
ClinicalTrials.gov: none 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.