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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126015441 | 12601544 | 1 | I | 20150203 | 20160728 | 20160728 | EXP | CA-JAZZ-2015-CA-022898 | JAZZ | 35.00 | MON | M | Y | 15.00000 | KG | 20160728 | CN | CA | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126015441 | 12601544 | 1 | PS | Asparaginase | ASPARAGINASE | 1 | Intravenous (not otherwise specified) | 1500 IU, CYCLICAL | U | 125359 | 1500 | IU | INJECTION | ||||||
| 126015441 | 12601544 | 2 | SS | Asparaginase | ASPARAGINASE | 1 | Intravenous (not otherwise specified) | 1500 IU, SINGLE | U | 125359 | 1500 | IU | INJECTION | ||||||
| 126015441 | 12601544 | 3 | SS | Asparaginase | ASPARAGINASE | 1 | Intravenous (not otherwise specified) | 1600 IU, CYCLICAL | U | 125359 | 1600 | IU | INJECTION | ||||||
| 126015441 | 12601544 | 4 | SS | LORAZEPAM. | LORAZEPAM | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 126015441 | 12601544 | 5 | SS | LORAZEPAM. | LORAZEPAM | 1 | Oral | UNK | U | 0 | |||||||||
| 126015441 | 12601544 | 6 | C | CYTARABINE. | CYTARABINE | 1 | Intrathecal | U | 0 | ||||||||||
| 126015441 | 12601544 | 7 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Oral | UNK | U | 0 | |||||||||
| 126015441 | 12601544 | 8 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | INTRA-AURAL | UNK | U | 0 | |||||||||
| 126015441 | 12601544 | 9 | C | DOXORUBICIN HYDROCHLORIDE. | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 126015441 | 12601544 | 10 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 126015441 | 12601544 | 11 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Topical | UNK | U | 0 | |||||||||
| 126015441 | 12601544 | 12 | C | HYDROCORTISONE. | HYDROCORTISONE | 1 | Intrathecal | UNK | U | 0 | |||||||||
| 126015441 | 12601544 | 13 | C | METHOTREXATE. | METHOTREXATE | 1 | Intramuscular | UNK | U | 0 | |||||||||
| 126015441 | 12601544 | 14 | C | METHOTREXATE. | METHOTREXATE | 1 | Intravenous (not otherwise specified) | UNK | U | 0 | |||||||||
| 126015441 | 12601544 | 15 | C | METHOTREXATE. | METHOTREXATE | 1 | Intrathecal | UNK | U | 0 | |||||||||
| 126015441 | 12601544 | 16 | C | METHYLPREDNISOLONE SODIUM SUCCINATE. | METHYLPREDNISOLONE SODIUM SUCCINATE | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 126015441 | 12601544 | 17 | C | Ondansetron | ONDANSETRON | 1 | Intravenous (not otherwise specified) | U | 0 | ||||||||||
| 126015441 | 12601544 | 18 | C | PREDNISONE. | PREDNISONE | 1 | Oral | U | 0 | ||||||||||
| 126015441 | 12601544 | 19 | C | VINCRISTINE SULFATE. | VINCRISTINE SULFATE | 1 | Intravenous (not otherwise specified) | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126015441 | 12601544 | 1 | Acute lymphocytic leukaemia |
| 126015441 | 12601544 | 4 | Product used for unknown indication |
| 126015441 | 12601544 | 6 | Product used for unknown indication |
| 126015441 | 12601544 | 7 | Product used for unknown indication |
| 126015441 | 12601544 | 9 | Product used for unknown indication |
| 126015441 | 12601544 | 10 | Product used for unknown indication |
| 126015441 | 12601544 | 13 | Product used for unknown indication |
| 126015441 | 12601544 | 16 | Product used for unknown indication |
| 126015441 | 12601544 | 17 | Product used for unknown indication |
| 126015441 | 12601544 | 18 | Product used for unknown indication |
| 126015441 | 12601544 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126015441 | 12601544 | HO |
| 126015441 | 12601544 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126015441 | 12601544 | Abdominal pain | |
| 126015441 | 12601544 | Apathy | |
| 126015441 | 12601544 | Ataxia | |
| 126015441 | 12601544 | Condition aggravated | |
| 126015441 | 12601544 | Decreased appetite | |
| 126015441 | 12601544 | Diplopia | |
| 126015441 | 12601544 | General physical health deterioration | |
| 126015441 | 12601544 | Headache | |
| 126015441 | 12601544 | Intracranial pressure increased | |
| 126015441 | 12601544 | Irritability | |
| 126015441 | 12601544 | Nausea | |
| 126015441 | 12601544 | Neutropenia | |
| 126015441 | 12601544 | Papilloedema | |
| 126015441 | 12601544 | Somnolence | |
| 126015441 | 12601544 | Strabismus | |
| 126015441 | 12601544 | Superior sagittal sinus thrombosis | |
| 126015441 | 12601544 | VIth nerve paralysis | |
| 126015441 | 12601544 | Vomiting |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |