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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115882533 | 11588253 | 3 | F | 20141016 | 20160913 | 20151002 | 20160920 | EXP | US-AMGEN-USASP2015100486 | AMGEN | 17.00 | YR | T | M | Y | 62.00000 | KG | 20160920 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115882533 | 11588253 | 1 | PS | NEULASTA | PEGFILGRASTIM | 1 | Unknown | UNK | U | 125031 | UNKNOWN FORMULATION | ||||||||
| 115882533 | 11588253 | 2 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2, CYCLIC (TWICE DAILY ON DAYS 1- 21) | 0 | 165 | MG/M**2 | ||||||||
| 115882533 | 11588253 | 3 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | 150 MG/M2,CYCLIC OVER 1-30 MINUTES EVERY 12 HOURS ON DAY 4 AND 5 | 0 | 150 | MG/M**2 | ||||||||
| 115882533 | 11588253 | 4 | SS | VP-16 | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 100 MG/M2, CYCLIC OVER 2 HOURS ON DAY 4 AND 5 | 0 | 100 | MG/M**2 | ||||||||
| 115882533 | 11588253 | 5 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 800 MG/M2, CYCLIC OVER 60 MINUTES ON DAY 1-5 | 0 | 800 | MG/M**2 | ||||||||
| 115882533 | 11588253 | 6 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | 7.5-12 MG, ON DAY 1 | 0 | ||||||||||
| 115882533 | 11588253 | 7 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | 3000 MG/M2, OVER 3 HOURS ON DAY 1 | 0 | 3000 | MG/M**2 | ||||||||
| 115882533 | 11588253 | 8 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 5 MG/M2, ONCE DAILY ON DAYS1-2 | 0 | 5 | MG/M**2 | QD | |||||||
| 115882533 | 11588253 | 9 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 5 MG/M2, CYCLIC TWICE DAILY ON DAYS 1-5 | 0 | 5 | MG/M**2 | ||||||||
| 115882533 | 11588253 | 10 | C | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 200 MG/M2, UNK | 0 | 200 | MG/M**2 | ||||||||
| 115882533 | 11588253 | 11 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | UNK (7.5-12 MG IT ON DAY 1 (AGE BASED DOSING) | 0 | |||||||||||
| 115882533 | 11588253 | 12 | C | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 25 MG/M2 IV OVER 1-15 MIN ON DAYS 4 AND 5 | 0 | 25 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115882533 | 11588253 | 1 | Product used for unknown indication |
| 115882533 | 11588253 | 2 | Anaplastic large cell lymphoma T- and null-cell types |
| 115882533 | 11588253 | 3 | Anaplastic large cell lymphoma T- and null-cell types |
| 115882533 | 11588253 | 4 | Anaplastic large cell lymphoma T- and null-cell types |
| 115882533 | 11588253 | 5 | Anaplastic large cell lymphoma T- and null-cell types |
| 115882533 | 11588253 | 6 | Anaplastic large cell lymphoma T- and null-cell types |
| 115882533 | 11588253 | 8 | Anaplastic large cell lymphoma T- and null-cell types |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115882533 | 11588253 | OT |
| 115882533 | 11588253 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115882533 | 11588253 | Back pain | |
| 115882533 | 11588253 | Hypertension | |
| 115882533 | 11588253 | Off label use |
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 |
|---|---|---|---|---|---|---|
| 115882533 | 11588253 | 6 | 20140708 | 0 | ||
| 115882533 | 11588253 | 9 | 20140708 | 0 | ||
| 115882533 | 11588253 | 10 | 20140708 | 0 | ||
| 115882533 | 11588253 | 11 | 20140708 | 20140708 | 0 |