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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125521781 | 12552178 | 1 | I | 20160524 | 20160704 | 20160713 | 20160713 | EXP | PT-INFARMED-L201606-130 | PT-ACTAVIS-2016-15251 | ACTAVIS | 53.32 | YR | F | Y | 66.00000 | KG | 20160713 | CN | PT | PT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125521781 | 12552178 | 1 | PS | DOCETAXEL. | DOCETAXEL | 1 | Intravenous bolus | 132 MG, CYCLICAL (EVERY 21 DAYS) | 5GJ5024 | 203551 | 132 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125521781 | 12552178 | 2 | SS | PERJETA | PERTUZUMAB | 1 | Intravenous bolus | 840 MG, CYCLICAL (EVERY 21 DAYS) | H0132B04 | 0 | 840 | MG | CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125521781 | 12552178 | 3 | SS | HERCEPTIN | TRASTUZUMAB | 1 | Intravenous bolus | 528 MG, CYCLICAL (EVERY 21 DAYS) | H4619H05 | 0 | 528 | MG | POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION | ||||||
| 125521781 | 12552178 | 4 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 1 DF, BID | U | 0 | 1 | DF | INHALATION POWDER | BID | |||||
| 125521781 | 12552178 | 5 | C | SALBUTAMOL | ALBUTEROL | 1 | Respiratory (inhalation) | 1 DF, PRN | U | 0 | 1 | DF | |||||||
| 125521781 | 12552178 | 6 | C | AAS | ASPIRIN | 1 | Oral | 150 MG, DAILY | U | 0 | 150 | MG | TABLET | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125521781 | 12552178 | 1 | Breast cancer |
| 125521781 | 12552178 | 2 | Breast cancer |
| 125521781 | 12552178 | 3 | Breast cancer |
| 125521781 | 12552178 | 4 | Chronic obstructive pulmonary disease |
| 125521781 | 12552178 | 5 | Chronic obstructive pulmonary disease |
| 125521781 | 12552178 | 6 | Thrombocytosis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125521781 | 12552178 | HO |
| 125521781 | 12552178 | DE |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125521781 | 12552178 | Acute kidney injury | |
| 125521781 | 12552178 | Anaemia | |
| 125521781 | 12552178 | Blood creatinine increased | |
| 125521781 | 12552178 | Blood urea increased | |
| 125521781 | 12552178 | Blood uric acid increased | |
| 125521781 | 12552178 | C-reactive protein increased | |
| 125521781 | 12552178 | Hypochromic anaemia | |
| 125521781 | 12552178 | Infection | |
| 125521781 | 12552178 | Leukocytosis | |
| 125521781 | 12552178 | Metabolic acidosis | |
| 125521781 | 12552178 | Microcytic anaemia | |
| 125521781 | 12552178 | Multiple organ dysfunction syndrome | |
| 125521781 | 12552178 | Neutrophil count increased | |
| 125521781 | 12552178 | Oliguria | |
| 125521781 | 12552178 | Pneumocystis jirovecii pneumonia | |
| 125521781 | 12552178 | Pyrexia | |
| 125521781 | 12552178 | Renal function test abnormal | |
| 125521781 | 12552178 | Respiratory failure | |
| 125521781 | 12552178 | Sepsis | |
| 125521781 | 12552178 | Tachycardia | |
| 125521781 | 12552178 | Tachypnoea |
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 |
|---|---|---|---|---|---|---|
| 125521781 | 12552178 | 1 | 20160506 | 20160506 | 0 | |
| 125521781 | 12552178 | 2 | 20160505 | 20160505 | 0 | |
| 125521781 | 12552178 | 3 | 20160506 | 20160506 | 0 | |
| 125521781 | 12552178 | 6 | 201511 | 0 |