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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124449262 | 12444926 | 2 | F | 20160426 | 20160804 | 20160607 | 20160812 | EXP | US-PFIZER INC-2016278682 | PFIZER | 3.00 | YR | M | Y | 11.40000 | KG | 20160812 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124449262 | 12444926 | 1 | PS | TEMSIROLIMUS | TEMSIROLIMUS | 1 | Intravenous (not otherwise specified) | 35 MG/M2/ DOSE, OVER 30 MIN ON DAYS 1 AND 8 | U | AJ64IN | 22088 | 35 | MG/M**2 | ||||||
| 124449262 | 12444926 | 2 | SS | CAMPTOSAR | IRINOTECAN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 50 MG/M2/DOSE, OVER 90 MIN ON DAYS 1-5 | U | 20571 | 50 | MG/M**2 | SOLUTION FOR INFUSION | ||||||
| 124449262 | 12444926 | 3 | SS | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | Intravenous (not otherwise specified) | 1.5 MG/M2/DOSE, 1 MIN OR INFUSION VIA MINIBAG ON DAYS 1 AND 8 | U | 71484 | 1.5 | MG/M**2 | SOLUTION FOR INJECTION | ||||||
| 124449262 | 12444926 | 4 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | UNK | 0 | |||||||||||
| 124449262 | 12444926 | 5 | C | ALBUTEROL. | ALBUTEROL | 1 | UNK | 0 | |||||||||||
| 124449262 | 12444926 | 6 | C | ZYPREXA | OLANZAPINE | 1 | UNK | 0 | |||||||||||
| 124449262 | 12444926 | 7 | C | OXYCODONE | OXYCODONE | 1 | UNK | 0 | |||||||||||
| 124449262 | 12444926 | 8 | C | BACTRIM | SULFAMETHOXAZOLETRIMETHOPRIM | 1 | UNK | 0 | |||||||||||
| 124449262 | 12444926 | 9 | C | ZOFRAN | ONDANSETRON HYDROCHLORIDE | 1 | UNK | 0 | |||||||||||
| 124449262 | 12444926 | 10 | C | CLINDAMYCIN | CLINDAMYCINCLINDAMYCIN PHOSPHATE | 1 | UNK | 0 | |||||||||||
| 124449262 | 12444926 | 11 | C | DOCUSATE | DOCUSATE | 1 | UNK | 0 | |||||||||||
| 124449262 | 12444926 | 12 | C | SENNA /00142201/ | SENNA LEAF | 1 | UNK | 0 | |||||||||||
| 124449262 | 12444926 | 13 | C | MORPHINE | MORPHINE | 1 | UNK | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124449262 | 12444926 | 1 | Hepatoblastoma |
| 124449262 | 12444926 | 2 | Hepatoblastoma |
| 124449262 | 12444926 | 3 | Hepatoblastoma |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124449262 | 12444926 | HO |
| 124449262 | 12444926 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124449262 | 12444926 | Blood bilirubin increased | |
| 124449262 | 12444926 | Colitis | |
| 124449262 | 12444926 | Dehydration | |
| 124449262 | 12444926 | Gamma-glutamyltransferase increased |
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 |
|---|---|---|---|---|---|---|
| 124449262 | 12444926 | 1 | 20160416 | 20160425 | 0 | |
| 124449262 | 12444926 | 2 | 20160416 | 20160420 | 0 | |
| 124449262 | 12444926 | 3 | 20160416 | 20160425 | 0 |