Comparison · NCT03324880-f7ff2904
rhPTH (1-84) vs Placebo: Number of Participants With Treatment Emergent Adverse Events (TEAEs)
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. rhPTH (1-84) vs Placebo: Number of Participants With Treatment Emergent Adverse Events (TEAEs). Trial comparisons, record NCT03324880-f7ff2904. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03324880-f7ff2904
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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 | 0.911 | 0.793 | 0.965 | wilson | |
| Risk in group 2 | 0.958 | 0.86 | 0.988 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0472 | -0.169 | 0.0646 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.951 | 0.853 | 1.06 | log | |
| Odds ratio, group 1 over group 2 | 0.446 | 0.0775 | 2.56 | log | |
| Number needed to treat, for one fewer participant with the outcome on rhPTH (1-84) than on Placebo | 21.2 | 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 | rhPTH (1-84) | Participants received rhPTH (1-84) 50 mcg SC injection QD, titrated within the dose range of 25-100 mcg QD as an adjunctive treatment with active vitamin D and calcium supplements based on metabolic response up to 32 weeks. | 41 | 45 | OG001 |
| Group 2 | Placebo | Participants received placebo matched to rhPTH (1-84) as SC injection QD with active vitamin D and calcium supplements up to 31.3 weeks. | 46 | 48 | OG000 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Number of Participants With Treatment Emergent Adverse Events (TEAEs)
- Description
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs are defined as AEs that started or worsened on or after the date and time of the first dose of investigational product.
- Time frame
- From start of study drug administration to 4 weeks post follow-up (up to Week 36)
- Population
- Safety Analysis Set included all participants in the ITT Set who took at least 1 dose of investigational product (study drug or placebo).
Source ClinicalTrials.gov
Trial
- Title
- A Study to Learn if Recombinant Human Parathyroid Hormone [rhPTH(1-84)] Can Improve Symptoms and Metabolic Control in Adults With Hypoparathyroidism (BALANCE)
- NCT number
- NCT03324880
- Phases
- PHASE4
- Conditions
- Hypoparathyroidism
- Interventions
- rhPTH (1-84), Placebo
- Lead sponsor
- Shire
- Results first posted
- 2023-06-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03324880?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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