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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115846063 | 11584606 | 3 | F | 20150116 | 20160914 | 20151001 | 20160919 | EXP | US-009507513-1509USA014140 | MERCK | 14.00 | YR | F | Y | 56.00000 | KG | 20160919 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 115846063 | 11584606 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | PROPHASE: 5 MG/M2 (ONCE DAILY ON DAYS 1-2, AND TWICE DAILY ON DAYS 3-5) | D | 12675 | 5 | MG/M**2 | TABLET | ||||||
| 115846063 | 11584606 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | COURSE A AND B: 5MG/M2 (TWICE DAILY ON DAYS 1-5) | D | 12675 | 5 | MG/M**2 | TABLET | ||||||
| 115846063 | 11584606 | 3 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | PROPHASE: 7.5-12 MG ON DAY 1 (AGE BASED DOSING) | D | 0 | TABLET | ||||||||
| 115846063 | 11584606 | 4 | SS | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | COURSE A,B: 3000 MG/M2, CYCLIC, (OVER 3 HOURS ON DAY 1) | D | 0 | TABLET | ||||||||
| 115846063 | 11584606 | 5 | SS | HYDROCORTONE | HYDROCORTISONE | 1 | Intrathecal | 7.5-12MG, ON DAY 1, AGE BASED DOSING | U | 0 | TABLET | ||||||||
| 115846063 | 11584606 | 6 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | 25 MG/M2, CYCLICAL, OVER 1-15 MINUTES ON DAYS 4 AND 5 | D | 0 | 25 | MG/M**2 | INJECTION | |||||||
| 115846063 | 11584606 | 7 | SS | ETOPOSIDE. | ETOPOSIDE | 1 | Intravenous (not otherwise specified) | COURSE A: 100 MG/M2, CYCLICAL, OVER 2 HOURS ON DAYS 4 AND 5 | D | 0 | 100 | MG/M**2 | |||||||
| 115846063 | 11584606 | 8 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2, CYCLICAL, TWICE DAILY ON DAYS 1-21 | D | 0 | 165 | MG/M**2 | |||||||
| 115846063 | 11584606 | 9 | SS | CYTARABINE. | CYTARABINE | 1 | Intrathecal | PROPHASE: 15-24 MG ON DAY 1 (AGE BASED DOSING) | D | 0 | |||||||||
| 115846063 | 11584606 | 10 | SS | CYTARABINE. | CYTARABINE | 1 | Intravenous (not otherwise specified) | COURSE A: 150 MG/M2, CYCLICAL (OVER 1-30 MINUTES EVERY 12 HOURS ON DAYS 4 AND 5; TOTAL 4 DOSES) | D | 0 | 150 | MG/M**2 | |||||||
| 115846063 | 11584606 | 11 | SS | IFOSFAMIDE. | IFOSFAMIDE | 1 | Intravenous (not otherwise specified) | 800 MG/M2, CYCLICAL, OVER 60 MINUTES ON DAYS 1-5 | D | 0 | 800 | MG/M**2 | |||||||
| 115846063 | 11584606 | 12 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | PRO-PHASE: 200MG/M2, OVER 15-30 MINUTES ON DAYS 1 AND 2, ON DAYS 1-5 IN COURSE B | D | 0 | 200 | MG/M**2 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 115846063 | 11584606 | 1 | Anaplastic large cell lymphoma T- and null-cell types |
| 115846063 | 11584606 | 3 | Anaplastic large cell lymphoma T- and null-cell types |
| 115846063 | 11584606 | 7 | Anaplastic large cell lymphoma T- and null-cell types |
| 115846063 | 11584606 | 8 | Anaplastic large cell lymphoma T- and null-cell types |
| 115846063 | 11584606 | 9 | Anaplastic large cell lymphoma T- and null-cell types |
| 115846063 | 11584606 | 11 | Anaplastic large cell lymphoma T- and null-cell types |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 115846063 | 11584606 | HO |
| 115846063 | 11584606 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 115846063 | 11584606 | Haemoglobin decreased | |
| 115846063 | 11584606 | Pyrexia | |
| 115846063 | 11584606 | 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 |
|---|---|---|---|---|---|---|
| 115846063 | 11584606 | 2 | 20140710 | 20150112 | 0 | |
| 115846063 | 11584606 | 4 | 20140710 | 20150108 | 0 | |
| 115846063 | 11584606 | 6 | 20141220 | 0 | ||
| 115846063 | 11584606 | 7 | 20141010 | 20150112 | 0 | |
| 115846063 | 11584606 | 8 | 20150112 | 0 | ||
| 115846063 | 11584606 | 10 | 20141010 | 20150112 | 0 | |
| 115846063 | 11584606 | 11 | 20140710 | 20150111 | 0 | |
| 115846063 | 11584606 | 12 | 20141220 | 0 |