Comparison · NCT01158924-sae
Intradiscal rhGDF-5 (1.0mg) vs Intradiscal rhGDF-5 (2.0mg): 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. Intradiscal rhGDF-5 (1.0mg) vs Intradiscal rhGDF-5 (2.0mg): serious adverse events. Trial comparisons, record NCT01158924-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01158924-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 | 0.0714 | 0.0127 | 0.315 | wilson | |
| Risk in group 2 | 0.154 | 0.0615 | 0.335 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0824 | -0.273 | 0.178 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.464 | 0.0573 | 3.76 | log | |
| Odds ratio, group 1 over group 2 | 0.423 | 0.0426 | 4.2 | log | |
| Number needed to treat, for one fewer participant with a serious adverse event on Intradiscal rhGDF-5 (1.0mg) than on Intradiscal rhGDF-5 (2.0mg) | 12.1 | 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 | Intradiscal rhGDF-5 (1.0mg) | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. | 1 | 14 | EG000 |
| Group 2 | Intradiscal rhGDF-5 (2.0mg) | The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. | 4 | 26 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
- Adverse events were collected through a 12 month period and annual telephone contact at 24 months and 36 months
Source ClinicalTrials.gov
Trial
- Title
- A Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration
- NCT number
- NCT01158924
- Phases
- PHASE1, PHASE2
- Conditions
- Early Lumbar Disc Degeneration
- Interventions
- Intradiscal rhGDF-5
- Lead sponsor
- DePuy Spine
- Results first posted
- 2016-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01158924?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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