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An event is serious (FDA MedWatch definition) when the patient outcome is:
* congenital anomaly
* requires intervention to prevent permanent impairment or damage
A 56-year-old man developed fatigue and ototoxicity following the administration of cisplatin and pemetrexed [routes not stated].
The man, who had been diagnosed with malignant pleural mesothelioma, was started on chemotherapy with cisplatin 75 mg/m2 and pemetrexed 500 mg/m2 on 14 November 2014. After the first cycle, he experienced mild fatigue. He received total 6 cycles of cisplatin and pemetrexed. Later, he received only pemetrexed from the seventh cycle. After the seventh cycle, he developed self-limiting ototoxicity that leads dose reduction in the eighth and ninth cycle. Afterward, his chemotherapy was changed to carboplatin and pemetrexed. At follow-up, fourteen months after the diagnosis, he was continued on chemotherapy [outcomes not stated].
Author comment: "The observed toxicities were mild fatigue after the first cycle and self-limiting ototoxicity after 7 cycles."