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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127551841 | 12755184 | 1 | I | 20160704 | 20160801 | 20160916 | 20160916 | EXP | GB-BAUSCH-BL-2016-018480 | BAUSCH AND LOMB | 23.00 | YR | F | Y | 46.20000 | KG | 20160916 | OT | GB | GB |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127551841 | 12755184 | 1 | PS | TOBRAMYCIN. | TOBRAMYCIN | 1 | Intravenous (not otherwise specified) | U | 64052 | 460 | MG | QD | |||||||
| 127551841 | 12755184 | 2 | SS | TOBRAMYCIN. | TOBRAMYCIN | 1 | U | 64052 | |||||||||||
| 127551841 | 12755184 | 3 | SS | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 16D21T3H | 0 | 10 | MG | SOLUTION | |||||||
| 127551841 | 12755184 | 4 | SS | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Intravenous bolus | 16D21T3H | 0 | 10 | MG | SOLUTION | TID | ||||||
| 127551841 | 12755184 | 5 | SS | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | Y | 2PT16001UK | 0 | 4.5 | G | POWDER FOR SOLUTION FOR INFUSION | TID | |||||
| 127551841 | 12755184 | 6 | SS | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Y | 2PT16001UK | 0 | ||||||||||
| 127551841 | 12755184 | 7 | C | CALCICHEW D3 | CALCIUMCHOLECALCIFEROL | 1 | Oral | 0 | 2 | DF | |||||||||
| 127551841 | 12755184 | 8 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | Unknown | 1/1 AS NECESSARY | 0 | 10000 | IU | ||||||||
| 127551841 | 12755184 | 9 | C | DORNASE ALFA | DORNASE ALFA | 1 | 0 | 2.5 | MG | ||||||||||
| 127551841 | 12755184 | 10 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 0 | 20 | MG | |||||||||
| 127551841 | 12755184 | 11 | C | SALBUTAMOL | ALBUTEROL | 1 | 1 / 1 AS?NECESSARY | 0 | 100 | UG | |||||||||
| 127551841 | 12755184 | 12 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 0 | 1 | DF | BID | |||||||||
| 127551841 | 12755184 | 13 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | 0 | 1 | DF | BID | |||||||||
| 127551841 | 12755184 | 14 | C | VITAMIN E | .ALPHA.-TOCOPHEROL | 1 | Oral | 0 | 400 | IU | |||||||||
| 127551841 | 12755184 | 15 | C | VITAMIN K | PHYTONADIONE | 1 | Oral | 0 | 10 | MG | |||||||||
| 127551841 | 12755184 | 16 | C | TOBI PODHALER | TOBRAMYCIN | 1 | Unknown | 0 | 112 | MG | |||||||||
| 127551841 | 12755184 | 17 | C | COLOMYCIN | COLISTIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127551841 | 12755184 | 1 | Infective pulmonary exacerbation of cystic fibrosis |
| 127551841 | 12755184 | 2 | Infection |
| 127551841 | 12755184 | 3 | Catheter management |
| 127551841 | 12755184 | 4 | Medication dilution |
| 127551841 | 12755184 | 5 | Infective pulmonary exacerbation of cystic fibrosis |
| 127551841 | 12755184 | 6 | Condition aggravated |
| 127551841 | 12755184 | 7 | Product used for unknown indication |
| 127551841 | 12755184 | 8 | Malabsorption |
| 127551841 | 12755184 | 9 | Increased viscosity of bronchial secretion |
| 127551841 | 12755184 | 10 | Gastrooesophageal reflux disease |
| 127551841 | 12755184 | 11 | Dyspnoea |
| 127551841 | 12755184 | 12 | Increased viscosity of bronchial secretion |
| 127551841 | 12755184 | 13 | Wheezing |
| 127551841 | 12755184 | 14 | Vitamin supplementation |
| 127551841 | 12755184 | 15 | Vitamin supplementation |
| 127551841 | 12755184 | 16 | Product used for unknown indication |
| 127551841 | 12755184 | 17 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 127551841 | 12755184 | HO |
| 127551841 | 12755184 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127551841 | 12755184 | General physical condition abnormal | |
| 127551841 | 12755184 | Rash |
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 |
|---|---|---|---|---|---|---|
| 127551841 | 12755184 | 1 | 20160627 | 0 | ||
| 127551841 | 12755184 | 3 | 20160627 | 20160702 | 0 | |
| 127551841 | 12755184 | 4 | 20160627 | 0 | ||
| 127551841 | 12755184 | 5 | 20160627 | 20160702 | 0 |