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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126305994 | 12630599 | 4 | F | 20160716 | 20160909 | 20160808 | 20160916 | EXP | US-PFIZER INC-2016369140 | PFIZER | 16.00 | YR | M | Y | 59.00000 | KG | 20160916 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126305994 | 12630599 | 1 | SS | MYLOTARG | GEMTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 3 MG/M2, DAY 1 AND DAY 5 | Y | 0 | 3 | MG/M**2 | POWDER FOR SOLUTION FOR INJECTION | ||||||
| 126305994 | 12630599 | 2 | PS | DAPTOMYCIN. | DAPTOMYCIN | 1 | Intravenous (not otherwise specified) | 463 MG, DAILY FOR 7 DOSES | 202857 | 463 | MG | POWDER FOR INJECTION | QD | ||||||
| 126305994 | 12630599 | 3 | SS | DIFLUCAN | FLUCONAZOLE | 1 | Oral | 300 MG (1 TABLET), 2X/DAY FOR 21 DOSES | 19949 | 300 | MG | FILM-COATED TABLET | BID | ||||||
| 126305994 | 12630599 | 4 | SS | CORTEF | HYDROCORTISONE | 1 | Oral | 2.5 MG, 2X/DAY | 25 | MG | Y | 8697 | 2.5 | MG | TABLET | BID | |||
| 126305994 | 12630599 | 5 | SS | SOLU-MEDROL | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | 40 MG, ONCE PRIOR TO INFUSION | Y | 0 | 40 | MG | |||||||
| 126305994 | 12630599 | 6 | C | ATIVAN | LORAZEPAM | 1 | UNK | 0 | TABLET | ||||||||||
| 126305994 | 12630599 | 7 | C | MAGNESIUM OXIDE. | MAGNESIUM OXIDE | 1 | UNK | 0 | TABLET | ||||||||||
| 126305994 | 12630599 | 8 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 126305994 | 12630599 | 9 | C | ZOLINZA | VORINOSTAT | 1 | Oral | 400 MG, DAILY | 0 | 400 | MG | CAPSULE | |||||||
| 126305994 | 12630599 | 10 | C | LEVAQUIN | LEVOFLOXACIN | 1 | Oral | 500 MG, DAILY | 0 | 500 | MG | TABLET | |||||||
| 126305994 | 12630599 | 11 | C | ZYLOPRIM | ALLOPURINOL | 1 | UNK | 0 | TABLET |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126305994 | 12630599 | 1 | Acute myeloid leukaemia recurrent |
| 126305994 | 12630599 | 2 | Antibiotic therapy |
| 126305994 | 12630599 | 3 | Antifungal treatment |
| 126305994 | 12630599 | 4 | Adrenal insufficiency |
| 126305994 | 12630599 | 5 | Steroid therapy |
| 126305994 | 12630599 | 6 | Anxiety |
| 126305994 | 12630599 | 7 | Blood magnesium decreased |
| 126305994 | 12630599 | 8 | Nausea |
| 126305994 | 12630599 | 9 | Neoplasm malignant |
| 126305994 | 12630599 | 10 | Infection |
| 126305994 | 12630599 | 11 | Blood uric acid increased |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126305994 | 12630599 | OT |
| 126305994 | 12630599 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126305994 | 12630599 | Abdominal pain | |
| 126305994 | 12630599 | Blood bilirubin increased | |
| 126305994 | 12630599 | Hypokalaemia | |
| 126305994 | 12630599 | Hyponatraemia | |
| 126305994 | 12630599 | Lymphocyte count decreased | |
| 126305994 | 12630599 | Neutrophil count decreased | |
| 126305994 | 12630599 | Platelet count decreased | |
| 126305994 | 12630599 | Vomiting | |
| 126305994 | 12630599 | White blood cell count decreased |
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 |
|---|---|---|---|---|---|---|
| 126305994 | 12630599 | 1 | 20160715 | 20160719 | 0 | |
| 126305994 | 12630599 | 2 | 20160725 | 0 | ||
| 126305994 | 12630599 | 3 | 20160725 | 0 | ||
| 126305994 | 12630599 | 4 | 20160725 | 20160730 | 0 | |
| 126305994 | 12630599 | 5 | 20160724 | 20160724 | 0 | |
| 126305994 | 12630599 | 6 | 20160718 | 0 | ||
| 126305994 | 12630599 | 7 | 20160729 | 0 | ||
| 126305994 | 12630599 | 8 | 20151209 | 0 | ||
| 126305994 | 12630599 | 9 | 20160716 | 20160725 | 0 | |
| 126305994 | 12630599 | 10 | 20160725 | 20160808 | 0 | |
| 126305994 | 12630599 | 11 | 20160722 | 20160729 | 0 |