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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124043624 | 12404362 | 4 | F | 20160508 | 20160701 | 20160525 | 20160713 | EXP | US-PFIZER INC-2016263093 | PFIZER | 5.00 | YR | F | Y | 23.50000 | KG | 20160713 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124043624 | 12404362 | 1 | SS | MYLOTARG | GEMTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 2.5 MG, REGIMEN 2, COMBINATION THERAPY | 0 | 2.5 | MG | POWDER FOR SOLUTION FOR INJECTION | |||||||
| 124043624 | 12404362 | 2 | PS | FLUDARABINE PHOSPHATE. | FLUDARABINE PHOSPHATE | 1 | Intravenous (not otherwise specified) | 25 MG, EVERY 4 HOURS FOR 5 DOSES | 77790 | 25 | MG | ||||||||
| 124043624 | 12404362 | 3 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 1080 MG, SINGLE | 0 | 1080 | MG | ||||||||
| 124043624 | 12404362 | 4 | SS | THIOTEPA. | THIOTEPA | 1 | Intravenous (not otherwise specified) | 110 MG, Q24 HOURS FOR 2 DOSES | 220 | MG | 0 | 110 | MG | QD | |||||
| 124043624 | 12404362 | 5 | C | TYLENOL | ACETAMINOPHEN | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 6 | C | ACYCLOVIR. | ACYCLOVIR | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 7 | C | AMBISOME | AMPHOTERICIN B | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 8 | C | AMPHOTERICIN B LIPID COMPLEX | AMPHOTERICIN B | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 9 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 10 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 124043624 | 12404362 | 11 | C | CEFEPIME | CEFEPIME HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 124043624 | 12404362 | 12 | C | CYCLOSPORINE. | CYCLOSPORINE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 13 | C | DAPSONE. | DAPSONE | 1 | Oral | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 14 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 15 | C | BENADRYL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | 0 | ||||||||||||
| 124043624 | 12404362 | 16 | C | FILGRASTIM | FILGRASTIM | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 17 | C | FLUCONAZOLE. | FLUCONAZOLE | 1 | Oral | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 18 | C | HYDRALAZINE | HYDRALAZINE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 19 | C | LORAZEPAM. | LORAZEPAM | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 20 | C | MAGNESIUM SULFATE. | MAGNESIUM SULFATE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 21 | C | MESNA. | MESNA | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 22 | C | REGLAN | METOCLOPRAMIDE HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 23 | C | FLAGYL | METRONIDAZOLEMETRONIDAZOLE HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 124043624 | 12404362 | 24 | C | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 25 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 26 | C | PANTOPRAZOLE | PANTOPRAZOLE SODIUM | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 27 | C | URSODIOL. | URSODIOL | 1 | Oral | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 28 | C | VORICONAZOLE. | VORICONAZOLE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 29 | C | LASIX | FUROSEMIDE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 30 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 31 | C | HYDROXYZINE | HYDROXYZINEHYDROXYZINE HYDROCHLORIDE | 1 | Oral | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 32 | C | MORPHINE | MORPHINE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 33 | C | MORPHINE | MORPHINE | 1 | Intravenous (not otherwise specified) | UNK | 0 | ||||||||||
| 124043624 | 12404362 | 34 | C | OXYCODONE | OXYCODONE | 1 | Oral | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124043624 | 12404362 | 1 | Acute myeloid leukaemia recurrent |
| 124043624 | 12404362 | 2 | Acute myeloid leukaemia recurrent |
| 124043624 | 12404362 | 3 | Acute myeloid leukaemia recurrent |
| 124043624 | 12404362 | 4 | Acute myeloid leukaemia recurrent |
| 124043624 | 12404362 | 5 | Premedication |
| 124043624 | 12404362 | 6 | Prophylaxis |
| 124043624 | 12404362 | 7 | Antifungal prophylaxis |
| 124043624 | 12404362 | 8 | Antifungal treatment |
| 124043624 | 12404362 | 9 | Febrile neutropenia |
| 124043624 | 12404362 | 10 | Bacteraemia |
| 124043624 | 12404362 | 11 | Antibiotic prophylaxis |
| 124043624 | 12404362 | 12 | Prophylaxis |
| 124043624 | 12404362 | 13 | Prophylaxis |
| 124043624 | 12404362 | 14 | Premedication |
| 124043624 | 12404362 | 15 | Nausea |
| 124043624 | 12404362 | 17 | Antifungal prophylaxis |
| 124043624 | 12404362 | 18 | Hypertension |
| 124043624 | 12404362 | 19 | Nausea |
| 124043624 | 12404362 | 20 | Hypomagnesaemia |
| 124043624 | 12404362 | 21 | Chemotherapy |
| 124043624 | 12404362 | 22 | Nausea |
| 124043624 | 12404362 | 23 | Clostridium difficile colitis |
| 124043624 | 12404362 | 24 | Prophylaxis |
| 124043624 | 12404362 | 25 | Nausea |
| 124043624 | 12404362 | 26 | Prophylaxis |
| 124043624 | 12404362 | 27 | Diuretic therapy |
| 124043624 | 12404362 | 28 | Antifungal prophylaxis |
| 124043624 | 12404362 | 29 | Diuretic therapy |
| 124043624 | 12404362 | 30 | Prophylaxis |
| 124043624 | 12404362 | 31 | Pruritus |
| 124043624 | 12404362 | 32 | Pain |
| 124043624 | 12404362 | 34 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124043624 | 12404362 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124043624 | 12404362 | Dyspnoea | |
| 124043624 | 12404362 | Pulmonary oedema | |
| 124043624 | 12404362 | Respiratory failure | |
| 124043624 | 12404362 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 124043624 | 12404362 | 1 | 20160320 | 20160326 | 0 | |
| 124043624 | 12404362 | 2 | 20160430 | 20160504 | 0 | |
| 124043624 | 12404362 | 3 | 20160430 | 20160430 | 0 | |
| 124043624 | 12404362 | 4 | 20160501 | 20160502 | 0 | |
| 124043624 | 12404362 | 5 | 20160428 | 20160506 | 0 | |
| 124043624 | 12404362 | 6 | 20150914 | 0 | ||
| 124043624 | 12404362 | 7 | 20160428 | 20160428 | 0 | |
| 124043624 | 12404362 | 8 | 20160429 | 20160505 | 0 | |
| 124043624 | 12404362 | 9 | 20160321 | 0 | ||
| 124043624 | 12404362 | 12 | 20160503 | 0 | ||
| 124043624 | 12404362 | 13 | 20151026 | 20160430 | 0 | |
| 124043624 | 12404362 | 14 | 20160428 | 0 | ||
| 124043624 | 12404362 | 16 | 20160507 | 0 | ||
| 124043624 | 12404362 | 17 | 20160321 | 20160425 | 0 | |
| 124043624 | 12404362 | 18 | 20160506 | 0 | ||
| 124043624 | 12404362 | 19 | 20160426 | 0 | ||
| 124043624 | 12404362 | 20 | 20160501 | 20160505 | 0 | |
| 124043624 | 12404362 | 21 | 20160430 | 20160430 | 0 | |
| 124043624 | 12404362 | 22 | 20160502 | 0 | ||
| 124043624 | 12404362 | 23 | 20160414 | 20160428 | 0 | |
| 124043624 | 12404362 | 24 | 20160506 | 0 | ||
| 124043624 | 12404362 | 25 | 20160131 | 0 | ||
| 124043624 | 12404362 | 26 | 20160506 | 0 | ||
| 124043624 | 12404362 | 27 | 20160321 | 0 | ||
| 124043624 | 12404362 | 28 | 20160426 | 0 | ||
| 124043624 | 12404362 | 29 | 20160501 | 20160506 | 0 | |
| 124043624 | 12404362 | 30 | 20160428 | 20160506 | 0 | |
| 124043624 | 12404362 | 31 | 20160507 | 20160507 | 0 | |
| 124043624 | 12404362 | 32 | 20160429 | 20160502 | 0 | |
| 124043624 | 12404362 | 33 | 20160506 | 0 | ||
| 124043624 | 12404362 | 34 | 20160429 | 20160503 | 0 |