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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1221435612 | 12214356 | 12 | F | 20111119 | 20160829 | 20160328 | 20160905 | EXP | CA-ROCHE-1730531 | ROCHE | 49.05 | YR | F | Y | 54.00000 | KG | 20160905 | MD | CA | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1221435612 | 12214356 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 375 MG, BIW (EVERY 2 WEEKS) | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||
| 1221435612 | 12214356 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 10 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 11 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 12 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 13 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0061D,S0062,S0065E,S0066B,S0001E,S | 103976 | SOLUTION FOR INJECTION | |||||||
| 1221435612 | 12214356 | 14 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | 0 | ||||||||||
| 1221435612 | 12214356 | 15 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | Y | 0 | ||||||||||
| 1221435612 | 12214356 | 16 | SS | PREDNISONE. | PREDNISONE | 1 | Y | 0 | |||||||||||
| 1221435612 | 12214356 | 17 | SS | PREDNISONE. | PREDNISONE | 1 | Y | 0 | |||||||||||
| 1221435612 | 12214356 | 18 | C | SPIRIVA | TIOTROPIUM BROMIDE MONOHYDRATE | 1 | Unknown | U | 0 | ||||||||||
| 1221435612 | 12214356 | 19 | C | ADVAIR HFA | FLUTICASONE PROPIONATESALMETEROL XINAFOATE | 1 | Unknown | U | 0 | ||||||||||
| 1221435612 | 12214356 | 20 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | Unknown | U | 0 | ||||||||||
| 1221435612 | 12214356 | 21 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 1221435612 | 12214356 | 22 | C | ALVESCO | CICLESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 1221435612 | 12214356 | 23 | C | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | 50 MG, UNK | U | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1221435612 | 12214356 | 1 | Asthma |
| 1221435612 | 12214356 | 14 | Productive cough |
| 1221435612 | 12214356 | 15 | Dyspnoea |
| 1221435612 | 12214356 | 16 | Lung infection |
| 1221435612 | 12214356 | 17 | Pulmonary function test decreased |
| 1221435612 | 12214356 | 18 | Product used for unknown indication |
| 1221435612 | 12214356 | 19 | Product used for unknown indication |
| 1221435612 | 12214356 | 20 | Product used for unknown indication |
| 1221435612 | 12214356 | 21 | Product used for unknown indication |
| 1221435612 | 12214356 | 22 | Product used for unknown indication |
| 1221435612 | 12214356 | 23 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1221435612 | 12214356 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1221435612 | 12214356 | Blood pressure decreased | |
| 1221435612 | 12214356 | Contusion | |
| 1221435612 | 12214356 | Dizziness | |
| 1221435612 | 12214356 | Dry mouth | |
| 1221435612 | 12214356 | Dry throat | |
| 1221435612 | 12214356 | Dyspnoea | |
| 1221435612 | 12214356 | Emphysema | |
| 1221435612 | 12214356 | Fatigue | |
| 1221435612 | 12214356 | Forced expiratory volume decreased | |
| 1221435612 | 12214356 | Haemorrhage | |
| 1221435612 | 12214356 | Injection site pain | |
| 1221435612 | 12214356 | Insomnia | |
| 1221435612 | 12214356 | Laceration | |
| 1221435612 | 12214356 | Lung infection | |
| 1221435612 | 12214356 | Lung neoplasm malignant | |
| 1221435612 | 12214356 | Nasopharyngitis | |
| 1221435612 | 12214356 | Nausea | |
| 1221435612 | 12214356 | Paraesthesia | |
| 1221435612 | 12214356 | Petechiae | |
| 1221435612 | 12214356 | Pharyngitis | |
| 1221435612 | 12214356 | Pneumonia | |
| 1221435612 | 12214356 | Productive cough | |
| 1221435612 | 12214356 | Pruritus | |
| 1221435612 | 12214356 | Pruritus generalised | |
| 1221435612 | 12214356 | Pulmonary function test abnormal | |
| 1221435612 | 12214356 | Pulmonary function test decreased | |
| 1221435612 | 12214356 | Pulmonary mass | |
| 1221435612 | 12214356 | Rash erythematous | |
| 1221435612 | 12214356 | Skin lesion | |
| 1221435612 | 12214356 | Weight decreased | |
| 1221435612 | 12214356 | Weight increased |
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 |
|---|---|---|---|---|---|---|
| 1221435612 | 12214356 | 1 | 20111119 | 0 | ||
| 1221435612 | 12214356 | 2 | 20111229 | 0 | ||
| 1221435612 | 12214356 | 3 | 20130114 | 0 | ||
| 1221435612 | 12214356 | 4 | 20151027 | 0 | ||
| 1221435612 | 12214356 | 5 | 20151208 | 0 | ||
| 1221435612 | 12214356 | 6 | 20160315 | 0 | ||
| 1221435612 | 12214356 | 7 | 20160412 | 0 | ||
| 1221435612 | 12214356 | 8 | 20160426 | 0 | ||
| 1221435612 | 12214356 | 9 | 20160511 | 0 | ||
| 1221435612 | 12214356 | 10 | 20160622 | 0 | ||
| 1221435612 | 12214356 | 11 | 20160719 | 0 | ||
| 1221435612 | 12214356 | 12 | 20160801 | 0 | ||
| 1221435612 | 12214356 | 13 | 20160817 | 0 |