Comparison · NCT00766038-sae
Recombinant Human Growth Hormone vs Placebo Treatment: 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. Recombinant Human Growth Hormone vs Placebo Treatment: serious adverse events. Trial comparisons, record NCT00766038-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT00766038-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 | 0.0645 | 0.0179 | 0.207 | wilson | |
| Risk in group 2 | 0.0625 | 0.0173 | 0.201 | wilson | |
| Risk difference, group 1 minus group 2 | 0.00202 | -0.145 | 0.152 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 1.03 | 0.155 | 6.88 | log | |
| Odds ratio, group 1 over group 2 | 1.03 | 0.136 | 7.84 | log | |
| Number needed to harm, for one more participant with a serious adverse event on Recombinant Human Growth Hormone than on Placebo Treatment | 496 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Recombinant Human Growth Hormone | The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment.~Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements | 2 | 31 | EG000 |
| Group 2 | Placebo Treatment | Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding.~Placebo: SC injection daily | 2 | 32 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.
- NCT number
- NCT00766038
- Phases
- PHASE2
- Conditions
- Traumatic Brain Injury
- Interventions
- Recombinant human Growth Hormone, Placebo
- Lead sponsor
- University of Pennsylvania
- Results first posted
- 2019-11-18
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT00766038?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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