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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112210389 | 11221038 | 9 | F | 20141029 | 20160816 | 20150626 | 20160822 | EXP | CA-ROCHE-1599654 | ROCHE | 30.07 | YR | F | Y | 0.00000 | 20160822 | CN | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 112210389 | 11221038 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY FOUR WEEKS | U | S0060,S0062,S0065E,S0002F,S0003C | 103976 | 300 | MG | SOLUTION FOR INJECTION | |||||
| 112210389 | 11221038 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0062,S0065E,S0002F,S0003C | 103976 | SOLUTION FOR INJECTION | |||||||
| 112210389 | 11221038 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0062,S0065E,S0002F,S0003C | 103976 | SOLUTION FOR INJECTION | |||||||
| 112210389 | 11221038 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0062,S0065E,S0002F,S0003C | 103976 | SOLUTION FOR INJECTION | |||||||
| 112210389 | 11221038 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0062,S0065E,S0002F,S0003C | 103976 | SOLUTION FOR INJECTION | |||||||
| 112210389 | 11221038 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0062,S0065E,S0002F,S0003C | 103976 | SOLUTION FOR INJECTION | |||||||
| 112210389 | 11221038 | 7 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0062,S0065E,S0002F,S0003C | 103976 | SOLUTION FOR INJECTION | |||||||
| 112210389 | 11221038 | 8 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0062,S0065E,S0002F,S0003C | 103976 | SOLUTION FOR INJECTION | |||||||
| 112210389 | 11221038 | 9 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060,S0062,S0065E,S0002F,S0003C | 103976 | SOLUTION FOR INJECTION | |||||||
| 112210389 | 11221038 | 10 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | Respiratory (inhalation) | 8-12 INH/DAY | U | 0 | |||||||||
| 112210389 | 11221038 | 11 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 112210389 | 11221038 | 12 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | U | 0 | ||||||||||
| 112210389 | 11221038 | 13 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | FOR 5 DAYS AND FOR EXTRA 3 DAYS FOR A TOTAL OF 8 DAYS. | U | 0 | 50 | MG | |||||||
| 112210389 | 11221038 | 14 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 50 MG, UNK (FOR 3 DAYS) | U | 0 | 50 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 112210389 | 11221038 | 1 | Asthma |
| 112210389 | 11221038 | 10 | Product used for unknown indication |
| 112210389 | 11221038 | 11 | Product used for unknown indication |
| 112210389 | 11221038 | 12 | Pharyngitis streptococcal |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 112210389 | 11221038 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 112210389 | 11221038 | Aphonia | |
| 112210389 | 11221038 | Asthma | |
| 112210389 | 11221038 | Bronchitis | |
| 112210389 | 11221038 | Decreased activity | |
| 112210389 | 11221038 | Dyspnoea | |
| 112210389 | 11221038 | Fatigue | |
| 112210389 | 11221038 | Glossodynia | |
| 112210389 | 11221038 | Hypertension | |
| 112210389 | 11221038 | Joint dislocation | |
| 112210389 | 11221038 | Ligament sprain | |
| 112210389 | 11221038 | Ludwig angina | |
| 112210389 | 11221038 | Lung infection | |
| 112210389 | 11221038 | Malaise | |
| 112210389 | 11221038 | Mouth ulceration | |
| 112210389 | 11221038 | Nasopharyngitis | |
| 112210389 | 11221038 | Oropharyngeal pain | |
| 112210389 | 11221038 | Palatal swelling | |
| 112210389 | 11221038 | Pharyngitis streptococcal | |
| 112210389 | 11221038 | Sinusitis | |
| 112210389 | 11221038 | Swollen tongue | |
| 112210389 | 11221038 | Throat irritation |
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 |
|---|---|---|---|---|---|---|
| 112210389 | 11221038 | 1 | 20141029 | 0 | ||
| 112210389 | 11221038 | 2 | 20141126 | 0 | ||
| 112210389 | 11221038 | 3 | 20150219 | 0 | ||
| 112210389 | 11221038 | 4 | 20160301 | 0 | ||
| 112210389 | 11221038 | 5 | 20160331 | 0 | ||
| 112210389 | 11221038 | 6 | 20160426 | 0 | ||
| 112210389 | 11221038 | 7 | 20160524 | 0 | ||
| 112210389 | 11221038 | 8 | 20160621 | 0 | ||
| 112210389 | 11221038 | 9 | 20160719 | 0 | ||
| 112210389 | 11221038 | 12 | 20160323 | 0 | ||
| 112210389 | 11221038 | 14 | 20160323 | 0 |