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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113939963 | 11393996 | 3 | F | 20130826 | 20160729 | 20150819 | 20160804 | EXP | PHHY2013CA110056 | SANDOZ | 58.01 | YR | F | Y | 0.00000 | 20160804 | CN | COUNTRY NOT SPECIFIED | CA |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 113939963 | 11393996 | 1 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY FOUR WEEK | U | 0 | 300 | MG | |||||||
| 113939963 | 11393996 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY FOUR WEEK | U | 0 | 300 | MG | |||||||
| 113939963 | 11393996 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, UNK | U | 0 | 300 | MG | |||||||
| 113939963 | 11393996 | 4 | PS | PREDNISONE. | PREDNISONE | 1 | Unknown | 25 MG, QD | Y | 80336 | 25 | MG | QD | ||||||
| 113939963 | 11393996 | 5 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG, UNK | Y | 80336 | 20 | MG | |||||||
| 113939963 | 11393996 | 6 | C | QVAR | BECLOMETHASONE DIPROPIONATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113939963 | 11393996 | 7 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | UNK | U | 0 | |||||||||
| 113939963 | 11393996 | 8 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | 2 DF, BID | U | 0 | 2 | DF | BID | ||||||
| 113939963 | 11393996 | 9 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113939963 | 11393996 | 10 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | UNK | U | 0 | |||||||||
| 113939963 | 11393996 | 11 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | 2 DF (EVERY 2-3 WEEKS) | U | 0 | 2 | DF | |||||||
| 113939963 | 11393996 | 12 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 113939963 | 11393996 | 13 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | 1 DF, QD | U | 0 | 1 | DF | QD | ||||||
| 113939963 | 11393996 | 14 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 25 MG, QD (7 - 10 DAYS) | U | 0 | 25 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 113939963 | 11393996 | 1 | Asthma |
| 113939963 | 11393996 | 4 | Product used for unknown indication |
| 113939963 | 11393996 | 6 | Product used for unknown indication |
| 113939963 | 11393996 | 7 | Product used for unknown indication |
| 113939963 | 11393996 | 8 | Product used for unknown indication |
| 113939963 | 11393996 | 9 | Product used for unknown indication |
| 113939963 | 11393996 | 10 | Product used for unknown indication |
| 113939963 | 11393996 | 12 | Product used for unknown indication |
| 113939963 | 11393996 | 14 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 113939963 | 11393996 | HO |
| 113939963 | 11393996 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 113939963 | 11393996 | Asthma | |
| 113939963 | 11393996 | Blood glucose fluctuation | |
| 113939963 | 11393996 | Chest discomfort | |
| 113939963 | 11393996 | Cough | |
| 113939963 | 11393996 | Dyspnoea | |
| 113939963 | 11393996 | Emphysema | |
| 113939963 | 11393996 | Fatigue | |
| 113939963 | 11393996 | Granuloma | |
| 113939963 | 11393996 | Hyperglycaemia | |
| 113939963 | 11393996 | Hyperhidrosis | |
| 113939963 | 11393996 | Malaise | |
| 113939963 | 11393996 | Nodule | |
| 113939963 | 11393996 | Obstructive airways disorder | |
| 113939963 | 11393996 | Peripheral swelling | |
| 113939963 | 11393996 | Polydipsia | |
| 113939963 | 11393996 | Polyuria | |
| 113939963 | 11393996 | Rash | |
| 113939963 | 11393996 | Sarcoidosis | |
| 113939963 | 11393996 | Seasonal allergy | |
| 113939963 | 11393996 | Wheezing |
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 |
|---|---|---|---|---|---|---|
| 113939963 | 11393996 | 1 | 20120502 | 0 | ||
| 113939963 | 11393996 | 2 | 20131126 | 0 | ||
| 113939963 | 11393996 | 3 | 20141020 | 0 |