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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1061510624 | 10615106 | 24 | F | 20130708 | 20160720 | 20141201 | 20160727 | EXP | CA-ROCHE-1498147 | ROCHE | 52.09 | YR | F | Y | 83.00000 | KG | 20160727 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1061510624 | 10615106 | 1 | PS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | 375 | MG | SOLUTION FOR INJECTION | QOW | ||||||
| 1061510624 | 10615106 | 2 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 3 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 4 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 5 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 6 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 7 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 8 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 9 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 10 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 11 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 12 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 13 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 14 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 15 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 16 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 17 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 18 | SS | Omalizumab | OMALIZUMAB | 1 | Subcutaneous | S0060A,S0061D,S0062,S0065E,S006B,S0 | 103976 | SOLUTION FOR INJECTION | |||||||||
| 1061510624 | 10615106 | 19 | SS | TRAMADOL. | TRAMADOL | 1 | Unknown | TWICE EVERY 4 HOURS | U | 0 | 50 | MG | |||||||
| 1061510624 | 10615106 | 20 | SS | CORTISONE | CORTISONEHYDROCORTISONE | 1 | Unknown | U | 0 | ||||||||||
| 1061510624 | 10615106 | 21 | SS | PREGABALIN. | PREGABALIN | 1 | Unknown | U | 0 | ||||||||||
| 1061510624 | 10615106 | 22 | C | SYMBICORT | BUDESONIDEFORMOTEROL FUMARATE DIHYDRATE | 1 | 0 | ||||||||||||
| 1061510624 | 10615106 | 23 | C | QVAR | BECLOMETHASONE DIPROPIONATE | 1 | 0 | ||||||||||||
| 1061510624 | 10615106 | 24 | C | SINGULAIR | MONTELUKAST SODIUM | 1 | 0 | ||||||||||||
| 1061510624 | 10615106 | 25 | C | PREDNISONE. | PREDNISONE | 1 | Unknown | 0 | 20 | MG |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1061510624 | 10615106 | 1 | Asthma |
| 1061510624 | 10615106 | 19 | Product used for unknown indication |
| 1061510624 | 10615106 | 20 | Headache |
| 1061510624 | 10615106 | 21 | Herpes zoster |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1061510624 | 10615106 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1061510624 | 10615106 | Acne | |
| 1061510624 | 10615106 | Adverse drug reaction | |
| 1061510624 | 10615106 | Asthenia | |
| 1061510624 | 10615106 | Blood pressure decreased | |
| 1061510624 | 10615106 | Blood pressure increased | |
| 1061510624 | 10615106 | Blood urine present | |
| 1061510624 | 10615106 | Chalazion | |
| 1061510624 | 10615106 | Chills | |
| 1061510624 | 10615106 | Cholelithiasis | |
| 1061510624 | 10615106 | Dizziness | |
| 1061510624 | 10615106 | Eye infection | |
| 1061510624 | 10615106 | Fatigue | |
| 1061510624 | 10615106 | Flank pain | |
| 1061510624 | 10615106 | Gait disturbance | |
| 1061510624 | 10615106 | Headache | |
| 1061510624 | 10615106 | Herpes zoster | |
| 1061510624 | 10615106 | Herpes zoster oticus | |
| 1061510624 | 10615106 | Lacrimation increased | |
| 1061510624 | 10615106 | Malaise | |
| 1061510624 | 10615106 | Migraine | |
| 1061510624 | 10615106 | Nasopharyngitis | |
| 1061510624 | 10615106 | Nausea | |
| 1061510624 | 10615106 | Oedema | |
| 1061510624 | 10615106 | Ophthalmic herpes zoster | |
| 1061510624 | 10615106 | Oropharyngeal pain | |
| 1061510624 | 10615106 | Otorrhoea | |
| 1061510624 | 10615106 | Pain in extremity | |
| 1061510624 | 10615106 | Periarthritis | |
| 1061510624 | 10615106 | Post herpetic neuralgia | |
| 1061510624 | 10615106 | Post procedural complication | |
| 1061510624 | 10615106 | Productive cough | |
| 1061510624 | 10615106 | Pyrexia | |
| 1061510624 | 10615106 | Red blood cell count increased | |
| 1061510624 | 10615106 | Sense of oppression | |
| 1061510624 | 10615106 | Somnolence | |
| 1061510624 | 10615106 | Sputum discoloured | |
| 1061510624 | 10615106 | Urinary tract infection | |
| 1061510624 | 10615106 | Varicose vein | |
| 1061510624 | 10615106 | Weight increased | |
| 1061510624 | 10615106 | White blood cell count 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 |
|---|---|---|---|---|---|---|
| 1061510624 | 10615106 | 1 | 20130708 | 0 | ||
| 1061510624 | 10615106 | 2 | 201309 | 0 | ||
| 1061510624 | 10615106 | 3 | 20131020 | 0 | ||
| 1061510624 | 10615106 | 4 | 20131227 | 0 | ||
| 1061510624 | 10615106 | 5 | 20140206 | 0 | ||
| 1061510624 | 10615106 | 6 | 20140305 | 0 | ||
| 1061510624 | 10615106 | 7 | 20140416 | 0 | ||
| 1061510624 | 10615106 | 8 | 20141112 | 0 | ||
| 1061510624 | 10615106 | 9 | 20150917 | 0 | ||
| 1061510624 | 10615106 | 10 | 20151111 | 0 | ||
| 1061510624 | 10615106 | 11 | 20160205 | 0 | ||
| 1061510624 | 10615106 | 13 | 20160316 | 0 | ||
| 1061510624 | 10615106 | 14 | 20160413 | 0 | ||
| 1061510624 | 10615106 | 15 | 20160429 | 0 | ||
| 1061510624 | 10615106 | 16 | 20160511 | 0 | ||
| 1061510624 | 10615106 | 17 | 20160706 | 0 | ||
| 1061510624 | 10615106 | 18 | 20160720 | 0 | ||
| 1061510624 | 10615106 | 20 | 20130819 | 0 |