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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
* Drug interaction
An 18-year-old boy developed acquired Fanconi syndrome, osteopenia, metatarsal shaft fracture and prerenal azotaemia following the concomitant administration of emtricitabine/tenofovir disoproxil fumarate [tenofovir disoproxil fumarate/emtricitabine] and lopinavir/ritonavir [dosages and routes not stated].
The boy was diagnosed with HIV infection at the age of 15 years. He started receiving antiretroviral therapy with emtricitabine/tenofovir disoproxil fumarate and lopinavir/ritonavir. Two and a half years following the initiation of emtricitabine/tenofovir disoproxil fumarate, at the age of 18 years, he presented at a follow-up visit with pain in the right foot after a minor trauma. A X-ray revealed a minimally displaced fracture of right third metatarsal...