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Congress: ECR24
Poster Number: C-11689
Type: EPOS Radiographer (scientific)
Authorblock: J. S. Endrikat1, A. Ullmann1, C. Gerlinger1, A. Bhatti2, P. Lengsfeld1, A. Michel3; 1Berlin/DE, 2Whippany, NJ/US, 3Basel/CH
Disclosures:
Jan Siegfried Endrikat: Author: Bayer AG Employee: Bayer AG
Alexander Ullmann: Author: Bayer AG Employee: Bayer Ag
Christoph Gerlinger: Author: Bayer AG Employee: Bayer Ag
Aasia Bhatti: Author: Bayer AG Employee: Bayer Ag
Philipp Lengsfeld: Employee: Bayer Ag Author: Bayer AG
Alexander Michel: Employee: Bayer Ag Author: Bayer AG
Keywords: Contrast agents, CT, Contrast agent-intravenous, Safety, Drugs / Reactions
Results

1.) The Phase-IV-Analysis comprised 152,233 patients from 37 countries. In the full analysis set 145,033 were included in the sex cohort, 59,412 in the race cohort and 146,649 in the region/country cohort.

Fig 1: Phase-IV-Analysis - Disposition of Patients

2.) The GPV-Analysis was based on 78.72 and 118.56 million administrations for which sex or region/country exposures were estimable.

Fig 2: GPV IV Analysis – Administrations

Sex

1.) The Phase-IV-Analysis: The HSR incidence was significantly higher for women (0.72%) vs. men (0.55%) (p≤0.0001).

Fig 3: Incidence and Reporting Rates of HSRs by Sex (FAS)
The unadjusted odds ratio (OR) was 1.3 (CI 1.154; 1.499), the adjusted OR was 1.156 (CI 1.006; 1.328) (p=0.04).
Fig 4: Odds Ratios for HSRs in Women and Men in Observational Studies and Global Pharmacovigilance Database

2.) The GPV-Analysis: Reporting rates were 0.0102% for women and 0.0075% for men (p<0.0001). The OR was 1.36 (CI 1.3, 1.43).

Fig 3: Incidence and Reporting Rates of HSRs by Sex (FAS)

Race

1.) In the Phase-IV-Analysis no significantly different HSR incidences for white (0.70%) and Asian (0.61%) patients (p=0.3094) were detected.

Fig 5: Incidence of HSRs by Race (FAS)
No GPV exposure data by race was available.

Region/country

1.) In the Phase-IV-Analysis the overall world HSR incidence was 0.62%. Europe: 0.52%, Asia: 0.70% USA: 0.75%, Germany: 0.51%, China: 0.41%, South Korea: 0.76%.

2.) In the GPV-Analysis the overall world HSR reporting rate was 0.015%, varying across regions/countries.

Fig 6: HSR Incidence and Reporting Rates by Region (FAS)

Limitations

  • In Phase-IV-Analysis 7,200, 92,821 and 5,584 patients for sex, race, and region/country, respectively, had to be excluded upfront from FAS because of missing key data. In GPV-Analysis out of >333 million administrations only 78.72 million and 118.56 million were eligible for the sex and region/country evaluation, respectively. Race could not be analyzed at all as race is not captured by GPV and was not available in market research.
  • Serious cases reported in the Phase-IV-Analysis of the 4 observational studies are necessarily also included in the GPV database. However, these were just 905 cases in 17,841 cases.
  • In observational studies and even more in pharmacovigilance databases underreporting cannot be ruled out.
GALLERY