Comparison · NCT01182337-ea094751
Intradiscal rhGDF-5 1.0mg vs Vehicle Control: Treatment Emergent Adverse Events- Relationship to Study Drug
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. Intradiscal rhGDF-5 1.0mg vs Vehicle Control: Treatment Emergent Adverse Events- Relationship to Study Drug. Trial comparisons, record NCT01182337-ea094751. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01182337-ea094751
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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 | 0 | 0.149 | wilson | |
| Risk in group 2 | 0 | 0 | 0.299 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.299 | 0.149 | 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 treat | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: vehicle.
| 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. | 0 | 22 | OG000 |
| Group 2 | Vehicle Control | Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection~Vehicle control: Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection | 0 | 9 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Treatment Emergent Adverse Events- Relationship to Study Drug
- Description
- Number of patients with Treatment Emergent Adverse Events that were designated as Definitely Related to Study Drug.
- Time frame
- Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up
- Population
- Safety Population
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
- NCT01182337
- Phases
- PHASE1, PHASE2
- Conditions
- Early Lumbar Disc Degeneration
- Interventions
- Intradiscal rhGDF-5, Vehicle control
- Lead sponsor
- DePuy Spine
- Results first posted
- 2016-01-27
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01182337?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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