An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case series reported by Pharmaceuticals and Medical Devices Agency, a woman in her 60s and a woman in her 80s [exact ages not stated] were described, who developed interstitial lung diseases during treatment with palbociclib for recurrent breast cancer with multiple metastases [routes not stated].
Case 1: A woman in her 60s started receiving palbociclib [Ibrance] capsules 125 mg/day alongside fulvestrant in cycles of 21 days. Prior to initiating the treatment, chest X-ray showed no significant findings. On day 35 of therapy, the dose of palbociclib was decreased to 100 mg/day. She continued receiving multiple cycles of 21 days at the reduced dosage, beginning on day 63, day 91, day 119. day 147, day 175, day 206, day 267 and day 287. On day 323, she was found to have...
- PMDA - Pharmaceuticals and Medical Devices Agency. Palbociclib Pharmaceuticals and Medical Devices Safety Information : Aug 2019. Available from: URL: http://www.pmda.go.jp/files/000230983.pdf - Japan