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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124831973 | 12483197 | 3 | F | 20160407 | 20160712 | 20160621 | 20160714 | EXP | US-009507513-1606USA007778 | MERCK | 12.00 | YR | M | Y | 50.00000 | KG | 20160714 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124831973 | 12483197 | 1 | PS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 5 MG/M2, BID, | 25 | MG/M2 | U | U | 12675 | 5 | MG/M**2 | TABLET | BID | ||
| 124831973 | 12483197 | 2 | SS | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | 5 MG/M2, BID, CYCLE 6, ON DAYS 1-5 | 25 | MG/M2 | U | U | 12675 | 5 | MG/M**2 | TABLET | BID | ||
| 124831973 | 12483197 | 3 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2, BID | 3300 | MG/M2 | U | U | 0 | 165 | MG/M**2 | BID | |||
| 124831973 | 12483197 | 4 | SS | CRIZOTINIB | CRIZOTINIB | 1 | Oral | 165 MG/M2, BID, CYCLE 6, ON DAYS 1-21 | 3300 | MG/M2 | U | U | 0 | 165 | MG/M**2 | BID | |||
| 124831973 | 12483197 | 5 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 25 MG/M2, QD, OVER 1-15 MINUTES | U | U | 0 | 25 | MG/M**2 | INJECTION | |||||
| 124831973 | 12483197 | 6 | SS | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | 25 MG/M2, QD, OVER 1-15 MINUTES, ON DAYS 4 AND 5, CYCLE 6 | U | U | 0 | 25 | MG/M**2 | INJECTION | |||||
| 124831973 | 12483197 | 7 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intrathecal | 3000 MG/M2 OVER 3 HOURS ON DAY 1 | U | U | 0 | 1X | |||||||
| 124831973 | 12483197 | 8 | SS | METHOTREXATE SODIUM. | METHOTREXATE SODIUM | 1 | Intravenous (not otherwise specified) | 3000 MG/M2 OVER 3 HOURS ON DAY 1, CYCLE 6 | U | U | 0 | ||||||||
| 124831973 | 12483197 | 9 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 200 MG/M2, OVER 15-30 MINUTES | 1000 | MG/M2 | U | U | 0 | 200 | MG/M**2 | QD | |||
| 124831973 | 12483197 | 10 | SS | CYCLOPHOSPHAMIDE. | CYCLOPHOSPHAMIDE | 1 | Intravenous (not otherwise specified) | 200 MG/M2, OVER 15-30 MINUTES, ON DAYS 1 AND 5, CYCLE 6 | 1000 | MG/M2 | U | U | 0 | 200 | MG/M**2 | QD | |||
| 124831973 | 12483197 | 11 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | UNK | U | U | 0 | |||||||||
| 124831973 | 12483197 | 12 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | UNK | U | U | 0 | |||||||||
| 124831973 | 12483197 | 13 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | UNK | U | U | 0 | |||||||||
| 124831973 | 12483197 | 14 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | UNK | U | U | 0 | |||||||||
| 124831973 | 12483197 | 15 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | UNK | U | U | 0 | |||||||||
| 124831973 | 12483197 | 16 | SS | LEUCOVORIN. | LEUCOVORIN | 1 | UNK | U | U | 0 | |||||||||
| 124831973 | 12483197 | 17 | SS | MESNA. | MESNA | 1 | UNK | U | U | 0 | |||||||||
| 124831973 | 12483197 | 18 | SS | MESNA. | MESNA | 1 | UNK | U | U | 0 | |||||||||
| 124831973 | 12483197 | 19 | SS | MESNA. | MESNA | 1 | UNK | U | U | 0 | |||||||||
| 124831973 | 12483197 | 20 | C | FOLINIC ACID | LEUCOVORIN | 1 | CYCLE 6 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124831973 | 12483197 | 1 | Anaplastic large cell lymphoma T- and null-cell types |
| 124831973 | 12483197 | 3 | Anaplastic large cell lymphoma T- and null-cell types |
| 124831973 | 12483197 | 5 | Anaplastic large cell lymphoma T- and null-cell types |
| 124831973 | 12483197 | 7 | Anaplastic large cell lymphoma T- and null-cell types |
| 124831973 | 12483197 | 9 | Anaplastic large cell lymphoma T- and null-cell types |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124831973 | 12483197 | OT |
| 124831973 | 12483197 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124831973 | 12483197 | Febrile neutropenia | |
| 124831973 | 12483197 | Gastroenteritis | |
| 124831973 | 12483197 | Hypotension | |
| 124831973 | 12483197 | Leptotrichia infection | |
| 124831973 | 12483197 | Pulmonary oedema | |
| 124831973 | 12483197 | Respiratory failure | |
| 124831973 | 12483197 | Sepsis | |
| 124831973 | 12483197 | Sinus tachycardia | |
| 124831973 | 12483197 | Stomatitis |
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 |
|---|---|---|---|---|---|---|
| 124831973 | 12483197 | 1 | 20151130 | 2016 | 0 | |
| 124831973 | 12483197 | 2 | 20160402 | 20160406 | 0 | |
| 124831973 | 12483197 | 3 | 20151130 | 2016 | 0 | |
| 124831973 | 12483197 | 4 | 20160402 | 20160411 | 0 | |
| 124831973 | 12483197 | 5 | 20151130 | 2016 | 0 | |
| 124831973 | 12483197 | 6 | 20160405 | 20160406 | 0 | |
| 124831973 | 12483197 | 7 | 20151130 | 2016 | 0 | |
| 124831973 | 12483197 | 8 | 20160402 | 20160402 | 0 | |
| 124831973 | 12483197 | 9 | 20151130 | 2016 | 0 | |
| 124831973 | 12483197 | 10 | 20160402 | 20160406 | 0 | |
| 124831973 | 12483197 | 11 | 20150209 | 20150210 | 0 | |
| 124831973 | 12483197 | 12 | 20151231 | 20160301 | 0 | |
| 124831973 | 12483197 | 13 | 20160123 | 20160124 | 0 | |
| 124831973 | 12483197 | 14 | 20160221 | 20160222 | 0 | |
| 124831973 | 12483197 | 15 | 20160313 | 20160315 | 0 | |
| 124831973 | 12483197 | 16 | 20160403 | 20160409 | 0 | |
| 124831973 | 12483197 | 17 | 20151207 | 20151212 | 0 | |
| 124831973 | 12483197 | 18 | 20160122 | 20160126 | 0 | |
| 124831973 | 12483197 | 19 | 20160312 | 20160316 | 0 | |
| 124831973 | 12483197 | 20 | 20160403 | 20160409 | 0 |