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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119847652 | 11984765 | 2 | F | 20160731 | 20160201 | 20160815 | EXP | US-APOPHARMA USA, INC.-2016AP006036 | APOTEX | 7.00 | MON | F | Y | 0.00000 | 20160815 | MD | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 119847652 | 11984765 | 1 | PS | ALKERAN | MELPHALAN | 1 | Intra-arterial | 0.4 MG/KG, OTHER | U | 20207 | .4 | MG/KG | INJECTION | ||||||
| 119847652 | 11984765 | 2 | C | CARBOPLATIN. | CARBOPLATIN | 1 | Intra-arterial | 50 MG, UNK | U | 0 | 50 | MG | |||||||
| 119847652 | 11984765 | 3 | C | TOPOTECAN | TOPOTECANTOPOTECAN HYDROCHLORIDE | 1 | Intra-arterial | 0.2 MG, UNK | U | 0 | .2 | MG | |||||||
| 119847652 | 11984765 | 4 | C | EPINEPHRINE. | EPINEPHRINE | 1 | Nasal | U | 0 | ||||||||||
| 119847652 | 11984765 | 5 | C | NEOSYNEPHRINE | PHENYLEPHRINE HYDROCHLORIDE | 1 | Topical | U | 0 | ||||||||||
| 119847652 | 11984765 | 6 | C | NEOSYNEPHRINE | PHENYLEPHRINE HYDROCHLORIDE | 1 | U | 0 | |||||||||||
| 119847652 | 11984765 | 7 | C | NEOSYNEPHRINE | PHENYLEPHRINE HYDROCHLORIDE | 1 | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 119847652 | 11984765 | 1 | Congenital retinoblastoma |
| 119847652 | 11984765 | 2 | Congenital retinoblastoma |
| 119847652 | 11984765 | 3 | Congenital retinoblastoma |
| 119847652 | 11984765 | 4 | Vasoconstriction |
| 119847652 | 11984765 | 5 | Oedema |
| 119847652 | 11984765 | 6 | Rash |
| 119847652 | 11984765 | 7 | Hyperaemia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 119847652 | 11984765 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 119847652 | 11984765 | Bronchospasm | |
| 119847652 | 11984765 | Neutropenia |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |