understanding the reported event.
Please respond to following questions regarding the adverse event – more pain in right knee and hard lump under the skin , involving a female patient, 58 Yrs. who was subscribed Forteo, reported the event to Lilly on 28/AUG/2014.
Please follow-up with Dr. Pornpong Itsarayapreuk, Maharaj Nakhon Chiangmai Hospital.
Please ask the following questions:
1. Was the hip and back surgery performed before starting Forteo?
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2. Was the patient hospitalized for the hip and back surgery?
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3. The reason for the hip and back surgery was stated as bone collapse due to osteoporosis; did the bone collapse occur before starting Forteo?
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4. Did the pain on hip and back started before Forteo?
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5. Did the pain on hip and back worsened while on Forteo?
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6. Did the pain of knee started before Forteo?
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7. Were any of these events related to Forteo? Please specify which one and the rationale:
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8. Was the hard lump under the skin at the injection site?
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9. Please provide onset date, final diagnosis, outcome and treatment administered for the event hard lump under the skin.
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10. Please provide a possible cause for the hard lump under the skin.
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11. Was the event related to Forteo? If yes, please provide a brief explanation.