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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116892143 | 11689214 | 3 | F | 20150831 | 20160628 | 20151102 | 20160705 | EXP | BE-ASTELLAS-2015US039076 | ASTELLAS | 15.00 | YR | M | Y | 0.00000 | 20160705 | CN | GB | BE |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 116892143 | 11689214 | 1 | PS | AMBISOME | AMPHOTERICIN B | 1 | Intravenous (not otherwise specified) | Y | 50740 | 3 | MG/KG | INJECTION | |||||||
| 116892143 | 11689214 | 2 | C | EUSAPRIM /00086101/ | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN | ||||||||
| 116892143 | 11689214 | 3 | C | DAFALGAN | ACETAMINOPHEN | 1 | Unknown | UNK UNK, UNKNOWN FREQ. | U | 0 | FORMULATION UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 116892143 | 11689214 | 1 | Antifungal treatment |
| 116892143 | 11689214 | 2 | Product used for unknown indication |
| 116892143 | 11689214 | 3 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 116892143 | 11689214 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 116892143 | 11689214 | Dyspnoea | |
| 116892143 | 11689214 | Oxygen saturation abnormal | |
| 116892143 | 11689214 | Product quality issue | |
| 116892143 | 11689214 | Swelling face | |
| 116892143 | 11689214 | Tachycardia | |
| 116892143 | 11689214 | Tachypnoea |
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 |
|---|---|---|---|---|---|---|
| 116892143 | 11689214 | 1 | 20150831 | 20150831 | 0 | |
| 116892143 | 11689214 | 2 | 20150831 | 0 |