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Comparison · NCT01234350-sae

FIRMAGON vs GnRH Agonist: serious adverse events

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. FIRMAGON vs GnRH Agonist: serious adverse events. Trial comparisons, record NCT01234350-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01234350-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.2360.2110.263wilson
Risk in group 20.2920.2540.334wilson
Risk difference, group 1 minus group 2-0.0561-0.105-0.00897newcombe hybrid score
Risk ratio, group 1 over group 20.8080.6770.964log
Odds ratio, group 1 over group 20.7490.5870.954log
Number needed to treat, for one fewer participant with a serious adverse event on FIRMAGON than on GnRH Agonist17.89.54112from the risk difference interval

Groups2

Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1FIRMAGONFIRMAGON (Degarelix, a GnRH antagonist) was prescribed in accordance with the approved label2361,000EG000
Group 2GnRH AgonistAny GnRH agonist prescribed in accordance with the approved labels144493EG001

Harm

What it counts
Total, serious adverse events
Time frame
From baseline upto 5 years (every 3 months from the first 2 years of the study; every 6 months for the last 3 years of the study)

Source ClinicalTrials.gov

Trial

Title
A Safety Study in Patients With Advanced Prostate Cancer Treated With FIRMAGON
NCT number
NCT01234350
Phases
Conditions
Prostate Cancer
Interventions
Lead sponsor
Ferring Pharmaceuticals
Results first posted
2019-05-20

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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