An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
Two patients (one man and one woman) in their 60s [exact ages at the time of reactions onsets not stated] were described, of whom the woman developed severe pain and retropharyngeal/prevertebral abscess following treatment with docetaxel and cetuximab. The man developed severe pain, bilateral pneumonia, Staphylococcus aureus infection with thoracic and lumbar paravertebral abscesses following treatment with cisplatin, fluorouracil [5-FU] and cetuximab.
Case 1: The woman was diagnosed with hypo-pharynx carcinoma in December 2014. Initially, she received definitive radio-chemotherapy. After six months, she received palliative chemotherapy with docetaxel per week combined with cetuximab [routes and dosages not stated]. After receiving four cycles, cetuximab dose was modified to...
- Gerlach C, et al. Severe Pain Due to Paraspinal Abscess Formation in Two Patients with Squamous-Cell Carcinoma of the Head and Neck after Multimodal Treatment Including Cetuximab. Oncology Research and Treatment 41: 395-398, No. 6, Jun 2018. Available from: URL: http://doi.org/10.1159/000486758 - GermanyCrossRefPubMedGoogle Scholar