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Patient dies in MacroGenics' cancer study, FDA puts trial on hold

The FDA has placed a partial clinical hold on MacroGenics’ Phase 2 study in gynecologic cancers after one patient died and three others experienced life-threatening side effects, the company disclosed Tuesday.

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The FDA has placed a partial clinical hold on MacroGenics’ Phase 2 study in gynecologic cancers after one patient died and three others experienced life-threatening side effects, the company disclosed Tuesday.

The patient who died had “grade 4 neutropenia and concurrent septic shock,” the company said in a press release. The other three grade 4 incidents included two cases of thrombocytopenia and one case of myocarditis, a type of heart inflammation.

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