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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126691642 | 12669164 | 2 | F | 20160704 | 20160822 | 20160819 | 20160902 | EXP | GB-MHRA-ADR 23585960 | GB-CHIESI USA INC.-GB-2016CHI001227 | CHIESI | 23.00 | YR | F | Y | 0.00000 | 20160902 | PH | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126691642 | 12669164 | 1 | PS | TOBRAMYCIN. | TOBRAMYCIN | 1 | Intravenous (not otherwise specified) | 460 MG, QD | U | U | 201820 | 460 | MG | ||||||
| 126691642 | 12669164 | 2 | SS | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | 4.5 G, TID | 81 | G | Y | 2PT16001UK | 0 | 4.5 | G | INJECTION | |||
| 126691642 | 12669164 | 3 | SS | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | Intravenous (not otherwise specified) | 10 ML, UNK | 81 | G | Y | 16D21T3H | 0 | 10 | ML | INJECTION | |||
| 126691642 | 12669164 | 4 | SS | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | 81 | G | Y | 0 | INJECTION | ||||||||
| 126691642 | 12669164 | 5 | SS | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 460 MG, UNK | 36 | DF | U | U | 0 | 460 | MG | INJECTION | ||||
| 126691642 | 12669164 | 6 | SS | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | Intravenous (not otherwise specified) | 2 DF, TID | 36 | DF | U | U | 16D21T3H | 0 | 2 | DF | INJECTION | ||
| 126691642 | 12669164 | 7 | C | CALCICHEW D3 | CALCIUMCHOLECALCIFEROL | 1 | Oral | 2 DF, UNK | U | 0 | 2 | DF | POWDER AND SOLVENT FOR ORAL SOLUTION | ||||||
| 126691642 | 12669164 | 8 | C | CREON | PANCRELIPASE AMYLASEPANCRELIPASE LIPASEPANCRELIPASE PROTEASE | 1 | 1-5 DF, PRN | U | 0 | ||||||||||
| 126691642 | 12669164 | 9 | C | DORNASE ALFA | DORNASE ALFA | 1 | 2.5 MG, DAILY | U | 0 | 2.5 | MG | INHALER | |||||||
| 126691642 | 12669164 | 10 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | 1 DF, BID | U | 0 | 1 | DF | INHALER | |||||||
| 126691642 | 12669164 | 11 | C | TOBRAMYCIN. | TOBRAMYCIN | 1 | 112 MG, ON ALTERNATE MONTHS | U | 0 | 112 | MG | ||||||||
| 126691642 | 12669164 | 12 | C | COLOMYCIN /06445401/ | 2 | 1 MU, ON ALTERNATE MONTHS | U | 0 | INHALER | ||||||||||
| 126691642 | 12669164 | 13 | C | OMEPRAZOLE. | OMEPRAZOLE | 1 | Oral | 20 MG, DAILY | U | 0 | 20 | MG | |||||||
| 126691642 | 12669164 | 14 | C | SALBUTAMOL | ALBUTEROL | 1 | 100 ?G, PRN | U | 0 | 100 | UG | INHALER | |||||||
| 126691642 | 12669164 | 15 | C | VITAMIN E /00110501/ | TOCOPHEROL | 1 | Oral | 400 IU, DAILY | U | 0 | 400 | IU | |||||||
| 126691642 | 12669164 | 16 | C | VITAMIN K /00854101/ | 2 | Oral | 10 MG, DAILY | U | 0 | 10 | MG | ||||||||
| 126691642 | 12669164 | 17 | C | MULTIVITAMIN /00097801/ | VITAMINS | 1 | Oral | 3 DF, TID | U | 0 | 3 | DF | |||||||
| 126691642 | 12669164 | 18 | C | SODIUM CHLORIDE. | SODIUM CHLORIDE | 1 | 1 DF, BID | U | 0 | 1 | DF | INHALER | |||||||
| 126691642 | 12669164 | 19 | C | PIPERACILLIN AND TAZOBACTAM | PIPERACILLIN SODIUMTAZOBACTAM SODIUM | 1 | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126691642 | 12669164 | 1 | Infection |
| 126691642 | 12669164 | 2 | Catheter management |
| 126691642 | 12669164 | 3 | Infective pulmonary exacerbation of cystic fibrosis |
| 126691642 | 12669164 | 4 | Condition aggravated |
| 126691642 | 12669164 | 5 | Medication dilution |
| 126691642 | 12669164 | 6 | Infective pulmonary exacerbation of cystic fibrosis |
| 126691642 | 12669164 | 7 | Vitamin supplementation |
| 126691642 | 12669164 | 8 | Malabsorption |
| 126691642 | 12669164 | 9 | Increased viscosity of bronchial secretion |
| 126691642 | 12669164 | 10 | Wheezing |
| 126691642 | 12669164 | 11 | Product used for unknown indication |
| 126691642 | 12669164 | 12 | Product used for unknown indication |
| 126691642 | 12669164 | 13 | Gastrooesophageal reflux disease |
| 126691642 | 12669164 | 14 | Dyspnoea |
| 126691642 | 12669164 | 15 | Vitamin supplementation |
| 126691642 | 12669164 | 16 | Vitamin supplementation |
| 126691642 | 12669164 | 17 | Vitamin supplementation |
| 126691642 | 12669164 | 18 | Increased viscosity of bronchial secretion |
| 126691642 | 12669164 | 19 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126691642 | 12669164 | OT |
| 126691642 | 12669164 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126691642 | 12669164 | General physical condition abnormal | |
| 126691642 | 12669164 | 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 |
|---|---|---|---|---|---|---|
| 126691642 | 12669164 | 2 | 20160627 | 20160702 | 0 | |
| 126691642 | 12669164 | 3 | 20160627 | 0 | ||
| 126691642 | 12669164 | 5 | 20160627 | 0 | ||
| 126691642 | 12669164 | 6 | 20160627 | 20160702 | 0 |