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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126892581 | 12689258 | 1 | I | 20160813 | 20160815 | 20160826 | 20160826 | EXP | ZA-JNJFOC-20160813559 | JANSSEN | 63.13 | YR | A | F | Y | 77.20000 | KG | 20160826 | MD | ZA | ZA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126892581 | 12689258 | 1 | PS | YONDELIS | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | N | 4371677 | 207953 | INTRAVENOUS INFUSION | ||||||||
| 126892581 | 12689258 | 2 | SS | YONDELIS | TRABECTEDIN | 1 | Intravenous (not otherwise specified) | MEDICATION KIT: 100032, 100041 | N | 4371677 | 114938 | 1.7 | MG | INTRAVENOUS INFUSION | |||||
| 126892581 | 12689258 | 3 | SS | DOXIL | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | N | 4371766 | 50718 | LIPOSOME INJECTION | ||||||||
| 126892581 | 12689258 | 4 | SS | DOXIL | DOXORUBICIN HYDROCHLORIDE | 1 | Intravenous (not otherwise specified) | MEDICATION KIT: 80437, 80438, 80439 | N | 4371766 | 36778 | 47.5 | MG | LIPOSOME INJECTION | |||||
| 126892581 | 12689258 | 5 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Intravenous drip | 0 | 20 | MG | UNSPECIFIED | ||||||||
| 126892581 | 12689258 | 6 | C | R-LOC | 2 | Intravenous drip | 0 | 50 | MG | UNSPECIFIED | |||||||||
| 126892581 | 12689258 | 7 | C | ONICIT | PALONOSETRON HYDROCHLORIDE | 1 | Intravenous drip | 0 | .25 | MG | UNSPECIFIED | ||||||||
| 126892581 | 12689258 | 8 | C | APREPITANT. | APREPITANT | 1 | Oral | 0 | 80 | MG | UNSPECIFIED | ||||||||
| 126892581 | 12689258 | 9 | C | APREPITANT. | APREPITANT | 1 | Oral | 0 | 125 | MG | UNSPECIFIED | ||||||||
| 126892581 | 12689258 | 10 | C | NEULASTIM | PEGFILGRASTIM | 1 | Subcutaneous | 0 | 6 | MG | UNSPECIFIED | ||||||||
| 126892581 | 12689258 | 11 | C | NEULASTIM | PEGFILGRASTIM | 1 | Subcutaneous | 0 | 6 | MG | UNSPECIFIED | ||||||||
| 126892581 | 12689258 | 12 | C | NEULASTIM | PEGFILGRASTIM | 1 | Subcutaneous | 0 | 6 | MG | UNSPECIFIED | ||||||||
| 126892581 | 12689258 | 13 | C | NEULASTIM | PEGFILGRASTIM | 1 | Subcutaneous | 0 | 6 | MG | UNSPECIFIED | ||||||||
| 126892581 | 12689258 | 14 | C | CLOPAMON | METOCLOPRAMIDE | 1 | Oral | 0 | 10 | MG | UNSPECIFIED | ||||||||
| 126892581 | 12689258 | 15 | C | CANNABIS | CANNABIS SATIVA SUBSP. INDICA TOP | 1 | Oral | 0 | .5 | ML | ORAL LIQUID | ||||||||
| 126892581 | 12689258 | 16 | C | PARACETAMOL | ACETAMINOPHEN | 1 | Oral | 0 | 500 | MG | UNSPECIFIED | BID | |||||||
| 126892581 | 12689258 | 17 | C | CIPROBAY URO | 2 | Oral | 0 | 500 | MG | UNSPECIFIED | BID | ||||||||
| 126892581 | 12689258 | 18 | C | CIPROBAY URO | 2 | Oral | 0 | 1000 | MG | UNSPECIFIED |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126892581 | 12689258 | 2 | Neoplasm malignant |
| 126892581 | 12689258 | 4 | Neoplasm malignant |
| 126892581 | 12689258 | 5 | Premedication |
| 126892581 | 12689258 | 6 | Gastrointestinal disorder therapy |
| 126892581 | 12689258 | 7 | Prophylaxis of nausea and vomiting |
| 126892581 | 12689258 | 8 | Prophylaxis of nausea and vomiting |
| 126892581 | 12689258 | 9 | Prophylaxis of nausea and vomiting |
| 126892581 | 12689258 | 10 | Neutropenia |
| 126892581 | 12689258 | 11 | Neutropenia |
| 126892581 | 12689258 | 12 | Prophylaxis |
| 126892581 | 12689258 | 13 | Prophylaxis |
| 126892581 | 12689258 | 14 | Nausea |
| 126892581 | 12689258 | 15 | Abdominal pain |
| 126892581 | 12689258 | 16 | Abdominal pain |
| 126892581 | 12689258 | 17 | Neutropenia |
| 126892581 | 12689258 | 18 | Neutropenia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126892581 | 12689258 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126892581 | 12689258 | Diarrhoea | |
| 126892581 | 12689258 | Small intestinal obstruction | |
| 126892581 | 12689258 | Vomiting |
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 |
|---|---|---|---|---|---|---|
| 126892581 | 12689258 | 2 | 20160419 | 0 | ||
| 126892581 | 12689258 | 4 | 20160419 | 0 | ||
| 126892581 | 12689258 | 5 | 20160419 | 0 | ||
| 126892581 | 12689258 | 6 | 20160419 | 0 | ||
| 126892581 | 12689258 | 7 | 20160419 | 0 | ||
| 126892581 | 12689258 | 8 | 20160420 | 0 | ||
| 126892581 | 12689258 | 9 | 20160419 | 0 | ||
| 126892581 | 12689258 | 10 | 20160428 | 20160428 | 0 | |
| 126892581 | 12689258 | 11 | 20160420 | 0 | ||
| 126892581 | 12689258 | 12 | 20160420 | 0 | ||
| 126892581 | 12689258 | 13 | 20160428 | 20160428 | 0 | |
| 126892581 | 12689258 | 14 | 20160426 | 0 | ||
| 126892581 | 12689258 | 15 | 201604 | 0 | ||
| 126892581 | 12689258 | 16 | 20160426 | 0 | ||
| 126892581 | 12689258 | 17 | 20160816 | 0 | ||
| 126892581 | 12689258 | 18 | 20160426 | 20160503 | 0 |