University of Birmingham

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First report 11 Sep 2019•Latest report 11 Sep 2019

Reports, concerns and published responses

Reports over time

Reports naming this recipient by issue year.

* 2026 is projected from reports observed to 7 Sep 2026.

Reports
1

Naming this recipient

Published responses
100%

Found for named reports

Concerns addressed
1

Across all linked responses

Stated actions
2

Described in responses

Concerns and recipient responses

Statements from University of Birmingham linked to the concerns in each report. Select any concern, action or position to view the source wording.

  1. West Yorkshire Eastern

    AI-generated summary

    Carl Anthony Schmidt · Prevention of Future Deaths report

    This summary was generated using AI from the published report. Please read the original report for the complete account.

    Report summary

    Carl Anthony Schmidt, a 51-year-old HGV driver, developed neurological symptoms after accelerated radiotherapy and chemotherapy for tonsillar cancer and died on 20 November 2018. The concerns were that the treatment could expose patients to neurological damage and that the mechanism of the injury required further investigation.

    Read the report on judiciary.uk

    Source evidence

    How this individual concern was interpreted

    PFD Monitor created a concise, searchable interpretation from the report wording shown below. The report was sent to University of Birmingham; that does not assign responsibility.

    PFD Monitor interpretation

    Neurological damage from the form of chemo radiotherapy

    Wider context from the report

    “(1) The form of chemo radiotherapy provided in the clinical trial potentially exposes the patient to neurological damage. (2) The mechanism by which the radiotherapy/chemotherapy treatment probably causes injury needs to be further investigated to establish whether this occurs directly or indirectly by affecting the immune system. ”
    Open source report

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Suspend recruitment into Arm 3 pending investigation into the circumstances of the death.

    Verbatim wording from the response

    “The CRCTU was notified of the outcome of the subsequent inquest by the Trial site at St James’ Institute of Oncology Leeds on 9th September 2019. This was a few days prior to receipt of the Regulation 28 Report dated 11th September. As the Chief Investigator, Professor ████████ immediately reviewed the situation with CRCTU and on 12th September 2019 arranged suspension of recruitment into Arm 3 of the Trial pending further investigation being undertaken around the circumstances of the death of the patient. He notified the TMG who were in agreement and he informed the chair of the DMC. The MHRA were sent a follow up report on 12th September and were notified of the suspension by telephone on 13th September and in writing on 16th September 2019. At the date of this Response, recruitment continues to be suspended.”

    Source location

    2019-0358-Responses_Redacted.pdf
    Page 3 · response
    Published 22 November 2019

    Open published response

    Source evidence

    How this respondent action was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Review Arm 3’s trial operation, risk mitigation, treatment, dosage and radiotherapy plans, and safety information through the Trial Management Group and Data Monitoring Committee.

    Verbatim wording from the response

    “In the light of the outcome of the Inquest and receipt by Professor ████████ of the Regulation 28 Report, a number of actions were undertaken to review the activity under the Trial.”

    Source location

    2019-0358-Responses_Redacted.pdf
    Page 3 · response
    Published 22 November 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    The experimental Arm 3 radiotherapy was not considered likely to have caused the death; alternative causes were considered more likely.

    Verbatim wording from the response

    “The DMC (and notably the radiotherapy oncology expert) reviewed all the available information (both the dosage plan and the radiotherapy outlining plan) and did not conclude that the patient’s symptoms or death were caused by direct damage from the radiotherapy on the local peripheral nerves. The reason for this is that the patient had polyneuropathy bilaterally including contralateral (left) arm and bilateral vocal cord palsy (i.e. including contralateral recurrent laryngeal nerve), whereas the high dose radiotherapy only affected the right recurrent laryngeal nerve and the right C5 root.”

    Source location

    2019-0358-Responses_Redacted.pdf
    Page 4 · response
    Published 22 November 2019

    Open published response

    Source evidence

    How this respondent position was interpreted

    PFD Monitor created a concise, searchable interpretation from the published response wording shown below.

    PFD Monitor interpretation

    Further suspension of Arm 3 recruitment was not considered necessary because the review identified no reasons to continue it.

    Verbatim wording from the response

    “The University has thoroughly reviewed the risk mitigation processes and operation of the Trial, the treatment provided, the potential benefit to patients, and the circumstances of this particular case. For the reasons mentioned above, the University does not believe that the experimental treatment given in Arm 3 is likely to have been the cause of death. Accordingly, and as the review has not identified reasons for continued suspension of Arm 3, the University (in consultation with the TMG and DMC) believes that resumption of recruitment into Arm 3 would be justified.”

    Source location

    2019-0358-Responses_Redacted.pdf
    Page 4 · response
    Published 22 November 2019

    Open published response
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Information checked against published PFD reports and official responses · Data reviewed 7 Sep 2026 · About data quality and limitations

Data last updated 7 September 2026