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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126499652 | 12649965 | 2 | F | 20160824 | 20160813 | 20160901 | EXP | JP-AMGEN-JPNSP2016105565 | AMGEN | OTOMO C. A PANCREATIC CANCER PATIENT IN WHOM PEGFILGRASTIM PROPHYLAXIS DID NOT PREVENT SEVERE NEUTROPENIA CAUSED BY THE FOLFIRINOX REGIMEN. JAPAN JOURNAL CANCER CHEMOTHERAPY. 2016;43:913-915 | 62.00 | YR | A | M | Y | 0.00000 | 20160901 | MD | JP | JP |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126499652 | 12649965 | 1 | PS | G-LASTA | PEGFILGRASTIM | 1 | Subcutaneous | 3.6 MG, 1X/2WEEKS | U | 125031 | 3.6 | MG | SOLUTION FOR INJECTION | QOW | |||||
| 126499652 | 12649965 | 2 | SS | GRAN | FILGRASTIM | 1 | Unknown | 75 MUG, UNK | U | 0 | 75 | UG | INJECTION | ||||||
| 126499652 | 12649965 | 3 | SS | GRAN | FILGRASTIM | 1 | Unknown | 75 MUG, UNK | U | 0 | 75 | UG | INJECTION | ||||||
| 126499652 | 12649965 | 4 | SS | GRAN | FILGRASTIM | 1 | Unknown | 75 MUG, UNK | U | 0 | 75 | UG | INJECTION | ||||||
| 126499652 | 12649965 | 5 | SS | GRAN | FILGRASTIM | 1 | Unknown | 150 MUG, UNK | U | 0 | 150 | UG | INJECTION | ||||||
| 126499652 | 12649965 | 6 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous bolus | 400 MG/M2, 1X/2WEEKS | 0 | 400 | MG/M**2 | QOW | |||||||
| 126499652 | 12649965 | 7 | SS | 5-FU /00098801/ | FLUOROURACIL | 1 | Intravenous drip | 2400 MG/M2, 1X/2WEEKS | 0 | 2400 | MG/M**2 | QOW | |||||||
| 126499652 | 12649965 | 8 | SS | OXALIPLATIN. | OXALIPLATIN | 1 | Intravenous drip | 85 MG, 1X/2WEEKS | 0 | 85 | MG | INJECTION | QOW | ||||||
| 126499652 | 12649965 | 9 | SS | IRINOTECAN HYDROCHLORIDE. | IRINOTECAN HYDROCHLORIDE | 1 | Intravenous drip | 150 MG, 1X/2WEEKS | 0 | 150 | MG | QOW | |||||||
| 126499652 | 12649965 | 10 | SS | LEVOFOLINATE CALCIUM | LEVOLEUCOVORIN CALCIUM | 1 | Intravenous drip | 200 MG/M2, 1X/2WEEKS | 0 | 200 | MG/M**2 | INJECTION | QOW | ||||||
| 126499652 | 12649965 | 11 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 4 G, UNK | 0 | 4 | G | ||||||||
| 126499652 | 12649965 | 12 | C | CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 1 | Intravenous drip | 70 MG, UNK | 0 | 70 | MG | INJECTION | |||||||
| 126499652 | 12649965 | 13 | C | CASPOFUNGIN ACETATE | CASPOFUNGIN ACETATE | 1 | Intravenous drip | 50 MG, UNK | 0 | 50 | MG | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126499652 | 12649965 | 1 | Colony stimulating factor prophylaxis |
| 126499652 | 12649965 | 2 | Colony stimulating factor prophylaxis |
| 126499652 | 12649965 | 6 | Pancreatic carcinoma |
| 126499652 | 12649965 | 8 | Pancreatic carcinoma |
| 126499652 | 12649965 | 9 | Pancreatic carcinoma |
| 126499652 | 12649965 | 10 | Pancreatic carcinoma |
| 126499652 | 12649965 | 11 | Febrile neutropenia |
| 126499652 | 12649965 | 12 | Febrile neutropenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126499652 | 12649965 | OT |
| 126499652 | 12649965 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126499652 | 12649965 | Colony stimulating factor therapy | |
| 126499652 | 12649965 | Febrile neutropenia | |
| 126499652 | 12649965 | Haemoglobin decreased | |
| 126499652 | 12649965 | Platelet count decreased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |