{
  "abstract": "(1) Background: the evaluation of app-based ePROs is increasingly being used in clinical trials with cancer patients while a medical effect for patients is a matter of controversy; (2) Methods: in the randomized (1:1) controlled PRO2 trial the effect of the mediduxTM app on the rate of \"high-grade AEs\" (HAEs, CTCAE severity ≥3) within patients receiving HER2-directed breast cancer treatment (arm A) was compared to a control-group that did not use the app (arm B); (3) Results: Among patients with observed (non-imputed) HAE data (n = 180 of N = 189 in the ITT population), the rates of documented HAEs were 21.51% in arm B and 17.24% in arm A. Logistic regression of HAE incidence in the full ITT population (N = 189), using reference-based multiple imputation for missing values, showed a positive tendency towards app use, but no significant difference (odds ratio arm (A/B): 0.797, 95% CI: 0.363, 1.752; p-value 0.569). Also, AE-related secondary endpoints \"emergency consultations\" (risk ratio arm (A/B): 0.842, 95% CI: 0.464, 1.522; p-value 0.570) and \"hospitalizations\" (risk ratio arm (A/B): 0.575, 95% CI: 0.237, 1.329; p-value 0.201) had no significant differences in negative binomial regression. (4) Conclusions: Although the effect on HAE rates was not statistically significant, intensive app use was observed and adverse events recorded by participants corresponded well with the known drug-side-effect-profiles. These exploratory findings suggest a potential supporting role of the app during out-patient cancer treatment, which needs confirmation in adequately powered studies.",
  "abstract_shown": true,
  "affiliations": [
    "Brustzentrum Zürichsee, Seestrase 80, 8810 Horgen, Switzerland.",
    "Department of Clinical Pharmacology and Toxicology, University Hospital Zurich, 8008 Zurich, Switzerland.",
    "Department of Gynecology and Obstetrics, Schleswig-Holstein University Hospital, Kiel Campus, 24105 Kiel, Germany.",
    "Department of Gynecology and Obstetrics, Klinikum Nürnberg, University Hospital of Paracelsus Medical University, 90419 Nuremberg, Germany.",
    "Practice Network Troisdorf, 53840 Troisdorf, Germany.",
    "Practice Network for Hematology and Oncology, 66822 Lebach, Germany.",
    "Knappschaft Kliniken Marienhospital Bottrop, 46236 Bottrop, Germany.",
    "Oncology Aschaffenburg, 63739 Aschaffenburg, Germany.",
    "Gynecological Oncology Practice, 38100 Braunschweig, Germany.",
    "Palleos Healthcare GmbH, 65189 Wiesbaden, Germany.",
    "Spital Zollikerberg, 8125 Zollikerberg, Switzerland.",
    "Center of Oncology & Hematology, Cancer Center Baselland, Kantonsspital Baselland, 4410 Liestal, Switzerland.",
    "Department of Radiation Oncology, University Hospital Zurich, 8008 Zurich, Switzerland.",
    "Department of Gynecology and Obstetrics, University Hospital Erlangen, Comprehensive Cancer Center Erlangen-EMN (CCC ER-EMN), 91054 Erlangen, Germany."
  ],
  "article_type": "research article",
  "arxiv": null,
  "author_total": 14,
  "authors": [
    {
      "affs": [
        0,
        1
      ],
      "name": "Andreas Trojan"
    },
    {
      "affs": [
        2
      ],
      "name": "Marion van Mackelenbergh"
    },
    {
      "affs": [
        3
      ],
      "name": "Cosima Brucker",
      "orcid": "0000-0001-7172-5218"
    },
    {
      "affs": [
        4
      ],
      "name": "Helmut Forstbauer"
    },
    {
      "affs": [
        5
      ],
      "name": "Markus Thiel"
    },
    {
      "affs": [
        6
      ],
      "name": "Hans-Christian Kolberg",
      "orcid": "0000-0003-0221-3272"
    },
    {
      "affs": [
        7
      ],
      "name": "Manfred Welslau"
    },
    {
      "affs": [
        8
      ],
      "name": "Janine Kreiss-Sender"
    },
    {
      "affs": [
        9
      ],
      "name": "Stefan Dröse"
    },
    {
      "affs": [
        10
      ],
      "name": "Sven Roth"
    },
    {
      "affs": [
        9
      ],
      "name": "Philip Raeth"
    },
    {
      "affs": [
        11
      ],
      "name": "Marcus Vetter",
      "orcid": "0009-0004-1003-1078"
    },
    {
      "affs": [
        12
      ],
      "name": "David Blum"
    },
    {
      "affs": [
        13
      ],
      "name": "Peter A Fasching"
    }
  ],
  "bibtex": "https://research.draconitic.com/paper/20nqjw3w9tqcj.bib",
  "cited_by": 0,
  "doi": "10.3390/curroncol33100618",
  "fulltext_url": "https://europepmc.org/articles/PMC13703651",
  "id": "20nqjw3w9tqcj",
  "issns": [
    "1198-0052",
    "1718-7729"
  ],
  "landing_url": "https://europepmc.org/article/MED/42930185",
  "language": "eng",
  "licence": "CC-BY",
  "licence_label": "CC BY",
  "licence_source": "article",
  "licence_url": "https://creativecommons.org/licenses/by/4.0/",
  "metadata_licence": null,
  "native_subjects": [
    [
      "openalex",
      "3600|Mobile Health and mHealth Applications"
    ]
  ],
  "openalex": "W7221785248",
  "pdf_url": "https://europepmc.org/articles/PMC13703651?pdf=render",
  "pmcid": "PMC13703651",
  "pmid": "42930185",
  "published": "2026-10-14",
  "publisher": null,
  "ris": "https://research.draconitic.com/paper/20nqjw3w9tqcj.ris",
  "sources": [
    {
      "first_seen": "2026-10-30T12:22:01Z",
      "native_id": "MED:42930185",
      "source": "europepmc",
      "url": "https://europepmc.org/article/MED/42930185"
    }
  ],
  "subjects": [
    {
      "field": "medicine",
      "origin": "journal-openalex:F27",
      "subfield": "general"
    }
  ],
  "title": "Incidence Rates of Adverse Events (CTCAE Severity ≥3) During HER2-Directed Breast Cancer Treatment Assessing the Impact of App-Based Electronic Patient-Reported Outcomes in the Randomized Controlled PRO2 Trial.",
  "title_text": "Incidence Rates of Adverse Events (CTCAE Severity ≥3) During HER2-Directed Breast Cancer Treatment Assessing the Impact of App-Based Electronic Patient-Reported Outcomes in the Randomized Controlled PRO2 Trial.",
  "type": "peer-reviewed",
  "updated_at": "2026-10-30T12:22:01Z",
  "url": "https://research.draconitic.com/paper/20nqjw3w9tqcj",
  "venue": "Current oncology (Toronto, Ont.)",
  "versions": []
}