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Review Trabectedin Safety Reports submitted to FDA

Total Trabectedin reports: 8.
Trabectedin FDA safety alerts: No.
   Reported hospitalizations: 8.
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FDA Reported Trabectedin Side Effects: vomiting, pyrexia, nausea, syncope vasovagal, septic shock, neutropenia, infection.
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Trabectedin Side Effects Report #5478121-4
Physician from KOREA, REPUBLIC OF reported TRABECTEDIN problem on June 17, 2007. Female patient, weighting 167.6 lb, was diagnosed with ovarian cancer and was treated with TRABECTEDIN. After drug was administered, patient experienced the following problems/side effects: neutropenia, septic shock. TRABECTEDIN dosage: unknown. During the same period patient was treated with DOXORUBICIN. Patient was hospitalized. Patient recovered.

Trabectedin Side Effects Report #5444486-2
TRABECTEDIN problem was reported by a Physician from CANADA on Aug 29, 2007. Female patient, weighting 162.9 lb, was diagnosed with ovarian cancer and was treated with TRABECTEDIN. After drug was administered, patient experienced the following problems/side effects: nausea, pyrexia, syncope vasovagal, vomiting. TRABECTEDIN dosage: unknown. During the same period patient was treated with DOXORUBICIN. Patient was hospitalized. Patient recovered.

Trabectedin Side Effects Report #5458093-9
Physician from KOREA, REPUBLIC OF reported TRABECTEDIN problem on Sept 11, 2007. Female patient, weighting 167.6 lb, was diagnosed with ovarian cancer and was treated with TRABECTEDIN. After drug was administered, patient experienced the following problems/side effects: neutropenia, septic shock. TRABECTEDIN dosage: unknown. During the same period patient was treated with DOXORUBICIN. Patient was hospitalized. Patient recovered.

Trabectedin Side Effects Report #5466969-1
TRABECTEDIN problem was reported by a Physician from KOREA, REPUBLIC OF on Sept 19, 2007. Female patient, weighting 167.6 lb, was diagnosed with ovarian cancer and was treated with TRABECTEDIN. After drug was administered, patient experienced the following problems/side effects: neutropenia, septic shock. TRABECTEDIN dosage: unknown. During the same period patient was treated with DOXORUBICIN. Patient was hospitalized. Patient recovered.

Trabectedin Side Effects Report #5471109-9
Physician from CANADA reported TRABECTEDIN problem on Sept 18, 2007. Female patient, weighting 151.0 lb, was diagnosed with ovarian cancer, constipation prophylaxis, pyrexia and was treated with TRABECTEDIN. After drug was administered, patient experienced the following problems/side effects: nausea, pyrexia, syncope vasovagal, vomiting. TRABECTEDIN dosage: unknown. During the same period patient was treated with DOXORUBICIN, LACTULOSE, NEUPOGENE, ATIVAN, TYLENOL. Patient was hospitalized. Patient recovered.

Trabectedin Side Effects Report #5422114-X
TRABECTEDIN problem was reported by a Physician from CANADA on Aug 15, 2007. Female patient, weighting 162.9 lb, was diagnosed with ovarian cancer and was treated with TRABECTEDIN. After drug was administered, patient experienced the following problems/side effects: nausea, pyrexia, vomiting. TRABECTEDIN dosage: unknown. During the same period patient was treated with DOXORUBICIN. Patient was hospitalized. Patient recovered.

Trabectedin Side Effects Report #5432970-7
Physician from CANADA reported TRABECTEDIN problem on Aug 21, 2007. Female patient, weighting 162.9 lb, was diagnosed with ovarian cancer and was treated with TRABECTEDIN. After drug was administered, patient experienced the following problems/side effects: infection, nausea, pyrexia, syncope vasovagal, vomiting. TRABECTEDIN dosage: unknown. During the same period patient was treated with DOXORUBICIN. Patient was hospitalized. Patient recovered.

Trabectedin Side Effects Report #5371894-0
TRABECTEDIN problem was reported by a Physician from KOREA, REPUBLIC OF on June 18, 2007. Female patient, weighting 183.0 lb, was diagnosed with ovarian cancer and was treated with TRABECTEDIN. After drug was administered, patient experienced the following problems/side effects: neutropenia, septic shock. TRABECTEDIN dosage: unknown. During the same period patient was treated with DOXORUBICIN. Patient was hospitalized. Patient recovered.


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