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Comparison · NCT02556710-sae

4 mL AMPION™ vs 4 mL Saline Placebo: 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. 4 mL AMPION™ vs 4 mL Saline Placebo: serious adverse events. Trial comparisons, record NCT02556710-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT02556710-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 10.008470.002330.0304wilson
Risk in group 20.01650.006420.0416wilson
Risk difference, group 1 minus group 2-0.00799-0.03380.0161newcombe hybrid score
Risk ratio, group 1 over group 20.5150.09522.78log
Odds ratio, group 1 over group 20.5110.09262.81log
Number needed to treat, for one fewer participant with a serious adverse event on 4 mL AMPION™ than on 4 mL Saline Placebo125from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 14 mL AMPION™AMPION™: 4 mL Ampion Injection2236EG000
Group 24 mL Saline PlaceboSaline: 4 mL Saline Injection4243EG001

Harm

What it counts
Total, serious adverse events
Time frame
12 Weeks

Source ClinicalTrials.gov

Trial

Title
A Study to Evaluate the Efficacy & Safety of an Intra-Articular Ampion Injection for Pain of Osteoarthritis of the Knee
NCT number
NCT02556710
Phases
PHASE3
Conditions
Osteoarthritis of the Knee
Interventions
4 mL injection of AMPION™, 4 mL injection of Placebo
Lead sponsor
Ampio Pharmaceuticals. Inc.
Results first posted
2022-08-08

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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