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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118521873 | 11852187 | 3 | F | 20141221 | 20160923 | 20151218 | 20160928 | EXP | US-009507513-1512USA008244 | MERCK | 14.00 | YR | F | Y | 59.00000 | KG | 20160928 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118521873 | 11852187 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 5 MG/M2, PROPHASE (CYCLE =5DAYS): QD ON DAYS 1-2 AND PO BID ON DAYS 3-5 | U | 12675 | 5 | MG/M**2 | TABLET | ||||||
| 118521873 | 11852187 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 5 MG/M2, COURSE A: BID ON DAYS 1-5 | U | 12675 | 5 | MG/M**2 | TABLET | ||||||
| 118521873 | 11852187 | 3 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 5 MG/M2, BID ON DAYS 1-5, COURSE B | U | 12675 | 5 | MG/M**2 | TABLET | ||||||
| 118521873 | 11852187 | 4 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 85 MG TOTAL DOSE | U | 12675 | TABLET | ||||||||
| 118521873 | 11852187 | 5 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 25 MG/M2, COURSE B: OVER 1-15 MIN ON DAYS 4 AND 5 | U | 0 | 25 | MG/M**2 | INJECTION | ||||||
| 118521873 | 11852187 | 6 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 84 MG TOTAL DOSE | U | 0 | INJECTION | ||||||||
| 118521873 | 11852187 | 7 | SS | ONDANSETRON HYDROCHLORIDE. | ONDANSETRON HYDROCHLORIDE | 1 | UNK | U | 0 | INJECTION | |||||||||
| 118521873 | 11852187 | 8 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intrathecal | 7.5-12 MG, PROPHASE (CYCLE=5DAYS), ON AGE 1 (AGE BASED DOSING) | U | 0 | |||||||||
| 118521873 | 11852187 | 9 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intravenous (not otherwise specified) | 3000 MG/M2, COURSE A: OVER 3 HOURS ON DAY 1 | U | 0 | |||||||||
| 118521873 | 11852187 | 10 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intravenous (not otherwise specified) | 3000 MG/M2, COURSE B: OVER 3 HOURS ON 1 DAY | U | 0 | |||||||||
| 118521873 | 11852187 | 11 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Unknown | 5070 MG TOTAL DOSE | U | 0 | |||||||||
| 118521873 | 11852187 | 12 | SS | VP-16 | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | 100 MG/M2, OVER 2 HOURS ON DAYS 4 AND 5 | U | 0 | 100 | MG/M**2 | |||||||
| 118521873 | 11852187 | 13 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 200 MG/M2, PROPHASE (CYCLE 5 DAYS), OVER 15-30 MINUTES ON DAYS 1 AND 2 | U | 0 | 200 | MG/M**2 | |||||||
| 118521873 | 11852187 | 14 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 200 MG/M2, COURSE B (CYCLE 5 DAYS), OVER 15-30 MINUTES ON 1 AND 5 | U | 0 | 200 | MG/M**2 | |||||||
| 118521873 | 11852187 | 15 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 1700 TOTAL DOSE | U | 0 | |||||||||
| 118521873 | 11852187 | 16 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2, BID ON DAYS 1-21 (TOTAL DOSE 2500 MG) | 157.143005 | MG/M2 | Y | ANHL12P1 | 0 | 165 | MG/M**2 | BID | |||
| 118521873 | 11852187 | 17 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2, BID ON DAYS 1-21 (TOTAL DOSE 2500 MG) | 157.143005 | MG/M2 | Y | ANHL12P1 | 0 | 165 | MG/M**2 | BID | |||
| 118521873 | 11852187 | 18 | C | CYTARABINE. | CYTARABINE | 1 | Intrathecal | 15-24 MG ON DAY 1 (AGE BASED DOSING) COURSE A: CYCLES 1, 3 AND 5 (CYCLE=21 DAYS) | U | 0 | |||||||||
| 118521873 | 11852187 | 19 | C | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 800 MG/M2 IV OVER 60 MINUTES ON DAYS 1-5 | U | 0 | |||||||||
| 118521873 | 11852187 | 20 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intrathecal | 7.5-12 MG IT ON DAY 1 (AGE BASED DOSING) | U | 0 | INJECTION |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118521873 | 11852187 | 1 | Anaplastic large cell lymphoma T- and null-cell types |
| 118521873 | 11852187 | 5 | Anaplastic large cell lymphoma T- and null-cell types |
| 118521873 | 11852187 | 8 | Anaplastic large cell lymphoma T- and null-cell types |
| 118521873 | 11852187 | 12 | Anaplastic large cell lymphoma T- and null-cell types |
| 118521873 | 11852187 | 13 | Anaplastic large cell lymphoma T- and null-cell types |
| 118521873 | 11852187 | 16 | Anaplastic large cell lymphoma T- and null-cell types |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118521873 | 11852187 | LT |
| 118521873 | 11852187 | HO |
| 118521873 | 11852187 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118521873 | 11852187 | Electrocardiogram QT prolonged | |
| 118521873 | 11852187 | Hypotension | |
| 118521873 | 11852187 | Sepsis |
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 |
|---|---|---|---|---|---|---|
| 118521873 | 11852187 | 1 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 2 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 3 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 4 | 20141217 | 20141221 | 0 | |
| 118521873 | 11852187 | 5 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 6 | 20141221 | 0 | ||
| 118521873 | 11852187 | 8 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 9 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 10 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 11 | 20141218 | 20141218 | 0 | |
| 118521873 | 11852187 | 12 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 13 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 14 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 15 | 20141217 | 20141221 | 0 | |
| 118521873 | 11852187 | 16 | 20141222 | 0 | ||
| 118521873 | 11852187 | 17 | 20141217 | 20141222 | 0 | |
| 118521873 | 11852187 | 18 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 19 | 201410 | 201412 | 0 | |
| 118521873 | 11852187 | 20 | 201410 | 201412 | 0 |