Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127416341 | 12741634 | 1 | I | 20100930 | 20151201 | 20160914 | 20160914 | EXP | FR-PFM-FR-2015-4868 | PIERRE FABRE MEDICAMENT | 8.28 | YR | F | Y | 0.00000 | 20160914 | CN | US | FR |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127416341 | 12741634 | 1 | PS | NAVELBINE | VINORELBINE TARTRATE | 1 | Intravenous (not otherwise specified) | UNK | U | 20388 | SOLUTION FOR INJECTION | ||||||||
| 127416341 | 12741634 | 2 | SS | NAVELBINE | VINORELBINE TARTRATE | 1 | U | 20388 | SOLUTION FOR INJECTION | ||||||||||
| 127416341 | 12741634 | 3 | SS | Holoxan | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 3 G/M2, QD (1/DAY), FIRST VI COURSE | U | 0 | POWDER FOR SOLUTION FOR INJECTION | QD | |||||||
| 127416341 | 12741634 | 4 | SS | Holoxan | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 3 G/M2, QD (1/DAY), ON DAY 2 AND 3, FIRST API COURSE | U | 0 | POWDER FOR SOLUTION FOR INJECTION | QD | |||||||
| 127416341 | 12741634 | 5 | SS | Holoxan | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 3 G/M2, QD (1/DAY), ON DAY 1 AND 2, FIRST AI COURSE | U | 0 | POWDER FOR SOLUTION FOR INJECTION | QD | |||||||
| 127416341 | 12741634 | 6 | SS | Holoxan | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 3 G/M2, QD (1/DAY), ON DAY 2 AND 3, SECOND API COURSE | U | 0 | POWDER FOR SOLUTION FOR INJECTION | QD | |||||||
| 127416341 | 12741634 | 7 | SS | Holoxan | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 3 G/M2, QD (1/DAY), ON DAY 1 AND 2, SECOND AI COURSE | U | 0 | POWDER FOR SOLUTION FOR INJECTION | QD | |||||||
| 127416341 | 12741634 | 8 | SS | Holoxan | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 3 G/M2, QD (1/DAY), ON DAY 2, THIRD API COURSE | U | 0 | POWDER FOR SOLUTION FOR INJECTION | QD | |||||||
| 127416341 | 12741634 | 9 | SS | Holoxan | IFOSFAMIDE | 1 | Unknown | POST OPERATIVE VI COURSE (DOSE WAS NOT REPORTED) | U | 0 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 127416341 | 12741634 | 10 | SS | Holoxan | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 3 G/M2, QD (1/DAY), ON DAY 1 AND 2, THIRD AI COURSE | U | 0 | POWDER FOR SOLUTION FOR INJECTION | QD | |||||||
| 127416341 | 12741634 | 11 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Unknown | UNK | U | 0 | POWDER FOR SOLUTION FOR INJECTION | ||||||||
| 127416341 | 12741634 | 12 | SS | Uromitexan | MESNA | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | SOLUTION FOR INJECTION | ||||||||
| 127416341 | 12741634 | 13 | SS | Uromitexan | MESNA | 1 | Intravenous (not otherwise specified) | DOSAGE WAS REDUCED FROM 50% | U | 0 | SOLUTION FOR INJECTION | ||||||||
| 127416341 | 12741634 | 14 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | 75 MG/M2, QD (1/DAY), FROM DAY 1 TO DAY 4, FIRST VI COURSE | U | 0 | 75 | MG/M**2 | CAPSULE | QD | |||||
| 127416341 | 12741634 | 15 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Unknown | POST-OPERATIVE FIRST VI COURSE | U | 0 | CAPSULE | ||||||||
| 127416341 | 12741634 | 16 | SS | METHOTREXATE. | METHOTREXATE | 1 | Unknown | FIRST OF 3 COURSES (1 IN 1 CYCLICAL) | U | 0 | |||||||||
| 127416341 | 12741634 | 17 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 100 MG/M2, ON DAY 1, FIRST API COURSE | U | 0 | |||||||||
| 127416341 | 12741634 | 18 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 100 MG/M2, ON DAY 1, SECOND API COURSE | U | 0 | |||||||||
| 127416341 | 12741634 | 19 | SS | CISPLATIN. | CISPLATIN | 1 | Unknown | 100 MG/M2, ON DAY 1, THIRD API COURSE | U | 0 | |||||||||
| 127416341 | 12741634 | 20 | SS | Doxorubicin ebewe | DOXORUBICIN | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 127416341 | 12741634 | 21 | SS | Cisplatin mylan | CISPLATIN | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 127416341 | 12741634 | 22 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 60 MG/M2, 1 IN 1 CYCLICAL, ON DAY 1, FIRST API COURSE | U | 0 | |||||||||
| 127416341 | 12741634 | 23 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 60 MG/M2, 1 IN 1 CYCLICAL, ON DAY 1, FIRST AI COURSE | U | 0 | |||||||||
| 127416341 | 12741634 | 24 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 60 MG/M2, 1 IN 1 CYCLICAL, ON DAY 1, SECOND API COURSE | U | 0 | |||||||||
| 127416341 | 12741634 | 25 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 60 MG/M2, 1 IN 1 CYCLICAL, ON DAY 1, SECOND AI COURSE | U | 0 | |||||||||
| 127416341 | 12741634 | 26 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 60 MG/M2, 1 IN 1 CYCLICAL, ON DAY 1, THIRD API COURSE | U | 0 | |||||||||
| 127416341 | 12741634 | 27 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 60 MG/M2, 1 IN 1 CYCLICAL, ON DAY 1, POST-OPERATIVE AI COURSE | U | 0 | |||||||||
| 127416341 | 12741634 | 28 | SS | ADRIAMYCIN | DOXORUBICIN HYDROCHLORIDE | 1 | Unknown | 60 MG/M2, 1 IN 1 CYCLICAL, ON DAY 1, AI COURSE | U | 0 | |||||||||
| 127416341 | 12741634 | 29 | C | Zelitrex | VALACYCLOVIR HYDROCHLORIDE | 1 | Unknown | 1 DOSAGE FORM | U | 0 | |||||||||
| 127416341 | 12741634 | 30 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | 800 MG, THRICE PER WEEK, ON MONDAY, WEDNESDAY AND FRIDAY | U | 0 | 2400 | MG | |||||||
| 127416341 | 12741634 | 31 | C | Laroxyl | AMITRIPTYLINE | 1 | Unknown | 1 TABLET OF 25 MG, QD (1/DAY) | U | 0 | 25 | MG | FILM-COATED TABLET | QD | |||||
| 127416341 | 12741634 | 32 | C | LAMICTAL | LAMOTRIGINE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127416341 | 12741634 | 1 | Chemotherapy |
| 127416341 | 12741634 | 2 | Osteosarcoma |
| 127416341 | 12741634 | 3 | Osteosarcoma |
| 127416341 | 12741634 | 11 | Chemotherapy |
| 127416341 | 12741634 | 12 | Osteosarcoma |
| 127416341 | 12741634 | 13 | Prophylaxis |
| 127416341 | 12741634 | 14 | Osteosarcoma |
| 127416341 | 12741634 | 16 | Osteosarcoma |
| 127416341 | 12741634 | 17 | Osteosarcoma |
| 127416341 | 12741634 | 20 | Osteosarcoma |
| 127416341 | 12741634 | 21 | Osteosarcoma |
| 127416341 | 12741634 | 22 | Osteosarcoma |
| 127416341 | 12741634 | 29 | Product used for unknown indication |
| 127416341 | 12741634 | 30 | Product used for unknown indication |
| 127416341 | 12741634 | 31 | Prophylaxis |
| 127416341 | 12741634 | 32 | Epilepsy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127416341 | 12741634 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127416341 | 12741634 | Death | |
| 127416341 | 12741634 | Off label use | |
| 127416341 | 12741634 | Product use issue |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 127416341 | 12741634 | 1 | 20100930 | 0 | ||
| 127416341 | 12741634 | 3 | 201004 | 0 | ||
| 127416341 | 12741634 | 4 | 201005 | 0 | ||
| 127416341 | 12741634 | 5 | 20100604 | 0 | ||
| 127416341 | 12741634 | 6 | 20100623 | 0 | ||
| 127416341 | 12741634 | 7 | 201007 | 0 | ||
| 127416341 | 12741634 | 8 | 20100812 | 20100812 | 0 | |
| 127416341 | 12741634 | 9 | 20100901 | 0 | ||
| 127416341 | 12741634 | 10 | 20100923 | 0 | ||
| 127416341 | 12741634 | 11 | 20100930 | 0 | ||
| 127416341 | 12741634 | 12 | 20100812 | 0 | ||
| 127416341 | 12741634 | 14 | 201004 | 0 | ||
| 127416341 | 12741634 | 15 | 20100901 | 0 | ||
| 127416341 | 12741634 | 16 | 20100316 | 0 | ||
| 127416341 | 12741634 | 17 | 201005 | 0 | ||
| 127416341 | 12741634 | 18 | 20100623 | 0 | ||
| 127416341 | 12741634 | 19 | 20100812 | 0 | ||
| 127416341 | 12741634 | 20 | 20100811 | 20100811 | 0 | |
| 127416341 | 12741634 | 21 | 20100811 | 20100811 | 0 | |
| 127416341 | 12741634 | 22 | 201005 | 0 | ||
| 127416341 | 12741634 | 23 | 20100604 | 0 | ||
| 127416341 | 12741634 | 24 | 20100623 | 0 | ||
| 127416341 | 12741634 | 25 | 201007 | 0 | ||
| 127416341 | 12741634 | 26 | 20100812 | 0 | ||
| 127416341 | 12741634 | 27 | 20100901 | 0 | ||
| 127416341 | 12741634 | 28 | 20100923 | 0 | ||
| 127416341 | 12741634 | 29 | 2006 | 0 | ||
| 127416341 | 12741634 | 30 | 2006 | 0 | ||
| 127416341 | 12741634 | 31 | 201005 | 0 |