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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127284331 | 12728433 | 1 | I | 201607 | 20160718 | 20160909 | 20160909 | EXP | US-PFIZER INC-2016351918 | PFIZER | 2.00 | YR | M | Y | 11.79000 | KG | 20160909 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127284331 | 12728433 | 1 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 0.45 MG, 0.8 MG/M2, ONCE | 5 | MG/M2 | 111-004189 | 0 | .45 | MG | |||||
| 127284331 | 12728433 | 2 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 0.28 MG, 0.5 MG/M2, ONE TIME | 5 | MG/M2 | 14-004189 | 0 | .28 | MG | |||||
| 127284331 | 12728433 | 3 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 0.28 MG, 0.5 MG/M2, ONE TIME | 5 | MG/M2 | 0 | .28 | MG | ||||||
| 127284331 | 12728433 | 4 | SS | INOTUZUMAB OZOGAMICIN | INOTUZUMAB OZOGAMICIN | 1 | Intravenous (not otherwise specified) | 0.45 MG, 0.8 MG/M2, ONCE A WEEK | 5 | MG/M2 | 111-004189 | 0 | .45 | MG/M**2 | /wk | ||||
| 127284331 | 12728433 | 5 | PS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intrathecal | 10 MG,(25MG/ML), SINGLE | U | 11719 | 10 | MG | |||||||
| 127284331 | 12728433 | 6 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | 20 MG, SINGLE | U | 71868 | 20 | MG | |||||||
| 127284331 | 12728433 | 7 | C | VINCRISTINE | VINCRISTINE | 1 | Intravenous (not otherwise specified) | 0.83 MG, 1.5 MG/M2, ONCE A DAY | .83 | MG | 0 | .83 | MG | QD | |||||
| 127284331 | 12728433 | 8 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous (not otherwise specified) | 2.752 MG, 5 MG/M2, ONCE | 0 | 2.752 | MG | ||||||||
| 127284331 | 12728433 | 9 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intrathecal | 10MG (100M/M2), ONE TIME | 0 | 10 | MG | ||||||||
| 127284331 | 12728433 | 10 | C | AMBISOME | AMPHOTERICIN B | 1 | Intravenous (not otherwise specified) | 80 MG, ONCE AT 15ML/HR OVER 2 HOURS | 0 | 80 | MG | ||||||||
| 127284331 | 12728433 | 11 | C | MEROPENEM. | MEROPENEM | 1 | Intravenous (not otherwise specified) | 500 MG, EVERY 8 HOURS | 0 | 500 | MG | TID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127284331 | 12728433 | 1 | Acute lymphocytic leukaemia recurrent |
| 127284331 | 12728433 | 5 | Acute lymphocytic leukaemia |
| 127284331 | 12728433 | 6 | Acute lymphocytic leukaemia |
| 127284331 | 12728433 | 7 | Acute lymphocytic leukaemia recurrent |
| 127284331 | 12728433 | 8 | Acute lymphocytic leukaemia recurrent |
| 127284331 | 12728433 | 9 | Acute lymphocytic leukaemia recurrent |
| 127284331 | 12728433 | 10 | Pneumonia fungal |
| 127284331 | 12728433 | 11 | Enterobacter infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127284331 | 12728433 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127284331 | 12728433 | Amylase decreased | |
| 127284331 | 12728433 | Blood bilirubin increased | |
| 127284331 | 12728433 | Blood chloride decreased | |
| 127284331 | 12728433 | Blood creatinine increased | |
| 127284331 | 12728433 | Blood urea increased | |
| 127284331 | 12728433 | Blood uric acid decreased | |
| 127284331 | 12728433 | Brain oedema | |
| 127284331 | 12728433 | Carbon dioxide abnormal | |
| 127284331 | 12728433 | Depressed level of consciousness | |
| 127284331 | 12728433 | Diarrhoea | |
| 127284331 | 12728433 | Febrile neutropenia | |
| 127284331 | 12728433 | Glossopharyngeal nerve disorder | |
| 127284331 | 12728433 | Hypersensitivity | |
| 127284331 | 12728433 | Hypertension | |
| 127284331 | 12728433 | Hypoalbuminaemia | |
| 127284331 | 12728433 | Hypocalcaemia | |
| 127284331 | 12728433 | Hypogammaglobulinaemia | |
| 127284331 | 12728433 | Hypokalaemia | |
| 127284331 | 12728433 | Hypomagnesaemia | |
| 127284331 | 12728433 | Hyponatraemia | |
| 127284331 | 12728433 | Hypophosphataemia | |
| 127284331 | 12728433 | Hypotension | |
| 127284331 | 12728433 | Lethargy | |
| 127284331 | 12728433 | Leukoencephalopathy | |
| 127284331 | 12728433 | Lipase decreased | |
| 127284331 | 12728433 | Mucosal haemorrhage | |
| 127284331 | 12728433 | Mucosal inflammation | |
| 127284331 | 12728433 | Oxygen saturation decreased | |
| 127284331 | 12728433 | Platelet count decreased | |
| 127284331 | 12728433 | Protein total abnormal | |
| 127284331 | 12728433 | Pyrexia | |
| 127284331 | 12728433 | Sinus tachycardia | |
| 127284331 | 12728433 | Swelling face | |
| 127284331 | 12728433 | Vomiting | |
| 127284331 | 12728433 | White blood cell count decreased | |
| 127284331 | 12728433 | Wound infection |
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 |
|---|---|---|---|---|---|---|
| 127284331 | 12728433 | 1 | 20160715 | 20160715 | 0 | |
| 127284331 | 12728433 | 2 | 20160722 | 20160722 | 0 | |
| 127284331 | 12728433 | 3 | 20160729 | 20160729 | 0 | |
| 127284331 | 12728433 | 4 | 20160819 | 0 | ||
| 127284331 | 12728433 | 5 | 20160802 | 20160819 | 0 | |
| 127284331 | 12728433 | 6 | 20160802 | 20160819 | 0 | |
| 127284331 | 12728433 | 7 | 20160707 | 20160707 | 0 | |
| 127284331 | 12728433 | 8 | 20160707 | 20160707 | 0 | |
| 127284331 | 12728433 | 9 | 20160802 | 20160802 | 0 | |
| 127284331 | 12728433 | 10 | 20160715 | 20160715 | 0 | |
| 127284331 | 12728433 | 11 | 20160712 | 0 |