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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126114501 | 12611450 | 1 | I | 20160726 | 20160801 | 20160801 | EXP | IT-PFIZER INC-2016364112 | PFIZER | FEDERICA SORA. MASSIVE PULMONARY EMBOLISM AT THE ONSET OF ACUTE PROMYELOCYTIC LEUKEMIA. MEDITERRANEAN JOURNAL OF HEMATOLOGY AND INFECTIOUS DISEASES. 2016;8(1): E2016027 | 24.00 | YR | F | Y | 0.00000 | 20160801 | MD | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126114501 | 12611450 | 1 | PS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | 0.5 MG/KG, UNK | U | 11153 | .5 | MG/KG | ||||||||
| 126114501 | 12611450 | 2 | SS | HEPARIN SODIUM. | HEPARIN SODIUM | 1 | Intravenous (not otherwise specified) | UNK | U | 18916 | SOLUTION FOR INJECTION | ||||||||
| 126114501 | 12611450 | 3 | SS | ATRA | TRETINOIN | 1 | Oral | 45MG/M2 PER DAY IN TWO DIVIDED | Y | 0 | 45 | MG/M**2 | |||||||
| 126114501 | 12611450 | 4 | SS | ALTEPLASE | ALTEPLASE | 1 | 100 MG, UNK | U | 0 | 100 | MG | ||||||||
| 126114501 | 12611450 | 5 | SS | ARSENIC TRIOXIDE | ARSENIC TRIOXIDE | 1 | 0.15 MG/KG, DAILY | U | 0 | .15 | MG/KG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126114501 | 12611450 | 1 | Prophylaxis |
| 126114501 | 12611450 | 3 | Acute promyelocytic leukaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126114501 | 12611450 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126114501 | 12611450 | Asthenia | |
| 126114501 | 12611450 | Chest pain | |
| 126114501 | 12611450 | Electrocardiogram T wave abnormal | |
| 126114501 | 12611450 | Hypotension | |
| 126114501 | 12611450 | Hypoxia | |
| 126114501 | 12611450 | Leukocytosis | |
| 126114501 | 12611450 | Tachypnoea | |
| 126114501 | 12611450 | Troponin increased |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |