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Review ArticleReview
Open Access

Adverse Events in Placebo Arms of Cancer Trials

JOHANNES E. WOLFF, BIRTE J. WOLFF, MARCEAL M. THIELEN and HOLGER HAUCH
Anticancer Research June 2022, 42 (6) 2805-2812; DOI: https://doi.org/10.21873/anticanres.15761
JOHANNES E. WOLFF
1AbbVie Inc, North Chicago, IL, U.S.A.;
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  • For correspondence: johannesewolff{at}gmail.com
BIRTE J. WOLFF
2Swedish Covenant Hospital Department of Gynecology, Chicago, IL, U.S.A.;
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MARCEAL M. THIELEN
1AbbVie Inc, North Chicago, IL, U.S.A.;
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HOLGER HAUCH
3Pediatric Hematology and Oncology, University Children’s Hospital Giessen, Hesse, Germany
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    Figure 1.

    Study flow diagram. The data collection grew over several published projects addressing specific adverse events (left side of the Figure). For this report, which combines all common adverse events, the publication year 2021 was added. The additional literature search is described on the right side of the Figure. TEAE: Treatment-emergent adverse event.

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    Figure 2.

    Box plot of the frequency of adverse events resulting in drug discontinuation among patients with different cancer diagnoses. Only diagnoses with more than 20 cohorts of patients available are shown. The box size represents the second and third quartile, and the line within it represents the median. The whiskers represent the first and fourth quartile (excluding outliers). Circles and stars indicate the outliers of the datasets.

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Anticancer Research
Vol. 42, Issue 6
June 2022
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Adverse Events in Placebo Arms of Cancer Trials
JOHANNES E. WOLFF, BIRTE J. WOLFF, MARCEAL M. THIELEN, HOLGER HAUCH
Anticancer Research Jun 2022, 42 (6) 2805-2812; DOI: 10.21873/anticanres.15761

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Adverse Events in Placebo Arms of Cancer Trials
JOHANNES E. WOLFF, BIRTE J. WOLFF, MARCEAL M. THIELEN, HOLGER HAUCH
Anticancer Research Jun 2022, 42 (6) 2805-2812; DOI: 10.21873/anticanres.15761
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Keywords

  • meta-analysis
  • systematic review
  • adverse events
  • placebo
  • cancer
  • Oncology
  • randomized trials
  • CTCAE
  • MedDRA
  • review
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