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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116183714 | 11618371 | 4 | F | 20150827 | 20160715 | 20151012 | 20160725 | EXP | PHHO2015US014127 | SANDOZ | 68.65 | YR | M | Y | 101.30000 | KG | 20160725 | OT | US | US |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116183714 | 11618371 | 1 | PS | FLUDARABINE | FLUDARABINE PHOSPHATE | 1 | Unknown | UNK | U | 22137 | |||||||||
| 116183714 | 11618371 | 2 | SS | HSC835 | INVESTIGATIONAL PRODUCT | 1 | Intravenous drip | 1.87 X 10^7 NC/KG | 0 | LIQUID | |||||||||
| 116183714 | 11618371 | 3 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | 200 MG, BID | 8796.22168 | MG | Y | 0 | 200 | MG | BID | ||||
| 116183714 | 11618371 | 4 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Oral | UNK | 8796.22168 | MG | Y | 0 | |||||||
| 116183714 | 11618371 | 5 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | 800 MG, 5 X/ DAY | Y | 0 | 800 | MG | |||||||
| 116183714 | 11618371 | 6 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Oral | UNK | Y | 0 | |||||||||
| 116183714 | 11618371 | 7 | C | LEVOFLOXACIN. | LEVOFLOXACIN | 1 | Oral | 250 MG, UNK | Y | 0 | 250 | MG | |||||||
| 116183714 | 11618371 | 8 | C | SULFAMETHOXAZOLE/TRIMETHOPRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Oral | 160 MG, BID | 0 | 160 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116183714 | 11618371 | 1 | Product used for unknown indication |
| 116183714 | 11618371 | 2 | Haematological malignancy |
| 116183714 | 11618371 | 3 | Antifungal prophylaxis |
| 116183714 | 11618371 | 5 | Antiviral prophylaxis |
| 116183714 | 11618371 | 7 | Antibiotic prophylaxis |
| 116183714 | 11618371 | 8 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116183714 | 11618371 | HO |
| 116183714 | 11618371 | LT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116183714 | 11618371 | Encephalopathy | |
| 116183714 | 11618371 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 116183714 | 11618371 | 2 | 20150805 | 20150805 | 0 | |
| 116183714 | 11618371 | 3 | 20150806 | 20151110 | 0 | |
| 116183714 | 11618371 | 5 | 20150801 | 20151110 | 0 | |
| 116183714 | 11618371 | 7 | 20150804 | 20151110 | 0 | |
| 116183714 | 11618371 | 8 | 20150920 | 0 |