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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127362461 | 12736246 | 1 | I | 201603 | 20160620 | 20160913 | 20160913 | PER | US-ASTRAZENECA-2016SE68203 | ASTRAZENECA | 904.00 | MON | F | Y | 56.70000 | KG | 20160913 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 127362461 | 12736246 | 1 | PS | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 80/4.5 MCG, 2 PUFFS TWICE A DAY | 21929 | ||||||||||
| 127362461 | 12736246 | 2 | SS | CRESTOR | ROSUVASTATIN CALCIUM | 1 | Oral | 0 | 10 | MG | TABLET | QD | |||||||
| 127362461 | 12736246 | 3 | C | TEMAZEPAM. | TEMAZEPAM | 1 | Oral | 0 | |||||||||||
| 127362461 | 12736246 | 4 | C | TRAMADOL. | TRAMADOL | 1 | Oral | 0 | |||||||||||
| 127362461 | 12736246 | 5 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Respiratory (inhalation) | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 127362461 | 12736246 | 1 | Chronic obstructive pulmonary disease |
| 127362461 | 12736246 | 2 | Prophylaxis |
| 127362461 | 12736246 | 3 | Insomnia |
| 127362461 | 12736246 | 5 | Chronic obstructive pulmonary disease |
Outcome of event
| no results found |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 127362461 | 12736246 | Decreased appetite | |
| 127362461 | 12736246 | Drug dose omission | |
| 127362461 | 12736246 | Dyspnoea | |
| 127362461 | 12736246 | Fatigue | |
| 127362461 | 12736246 | Off label use | |
| 127362461 | 12736246 | Product use issue | |
| 127362461 | 12736246 | Suffocation feeling | |
| 127362461 | 12736246 | Tachycardia | |
| 127362461 | 12736246 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 127362461 | 12736246 | 1 | 201603 | 0 | ||
| 127362461 | 12736246 | 5 | 2016 | 0 |