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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1168883111 | 11688831 | 11 | F | 201404 | 20160926 | 20151102 | 20160929 | EXP | CA-ROCHE-1653300 | ROCHE | 24.07 | YR | F | Y | 0.00000 | 20160929 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1168883111 | 11688831 | 1 | PS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | 300 MG, EVERY 4 WEEKS | U | S0060A,S0062,S0068B,S00068D | 103976 | 300 | MG | SOLUTION FOR INJECTION | |||||
| 1168883111 | 11688831 | 2 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0062,S0068B,S00068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 1168883111 | 11688831 | 3 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0062,S0068B,S00068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 1168883111 | 11688831 | 4 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0062,S0068B,S00068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 1168883111 | 11688831 | 5 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0062,S0068B,S00068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 1168883111 | 11688831 | 6 | SS | XOLAIR | OMALIZUMAB | 1 | Subcutaneous | UNK | U | S0060A,S0062,S0068B,S00068D | 103976 | SOLUTION FOR INJECTION | |||||||
| 1168883111 | 11688831 | 7 | SS | VYVANSE | LISDEXAMFETAMINE DIMESYLATE | 1 | Unknown | UNK | D | 0 | 40 | MG | |||||||
| 1168883111 | 11688831 | 8 | SS | CODEINE | CODEINE | 1 | Unknown | U | 0 | ||||||||||
| 1168883111 | 11688831 | 9 | SS | CONCERTA | METHYLPHENIDATE HYDROCHLORIDE | 1 | Unknown | D | 0 | ||||||||||
| 1168883111 | 11688831 | 10 | C | VENTOLIN | ALBUTEROL SULFATE | 1 | Unknown | U | 0 | ||||||||||
| 1168883111 | 11688831 | 11 | C | PULMICORT TURBUHALER | BUDESONIDE | 1 | Unknown | U | 0 | ||||||||||
| 1168883111 | 11688831 | 12 | C | ZENHALE | FORMOTEROL FUMARATEMOMETASONE FUROATE | 1 | Unknown | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1168883111 | 11688831 | 1 | Asthma |
| 1168883111 | 11688831 | 7 | Disturbance in attention |
| 1168883111 | 11688831 | 8 | Product used for unknown indication |
| 1168883111 | 11688831 | 9 | Product used for unknown indication |
| 1168883111 | 11688831 | 10 | Product used for unknown indication |
| 1168883111 | 11688831 | 11 | Product used for unknown indication |
| 1168883111 | 11688831 | 12 | Product used for unknown indication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1168883111 | 11688831 | OT |
| 1168883111 | 11688831 | HO |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1168883111 | 11688831 | Abdominal pain | |
| 1168883111 | 11688831 | Bronchitis bacterial | |
| 1168883111 | 11688831 | Confusional state | |
| 1168883111 | 11688831 | Diarrhoea | |
| 1168883111 | 11688831 | Dizziness | |
| 1168883111 | 11688831 | Ear pain | |
| 1168883111 | 11688831 | Eczema | |
| 1168883111 | 11688831 | Eye allergy | |
| 1168883111 | 11688831 | Gastrooesophageal reflux disease | |
| 1168883111 | 11688831 | Gingivitis | |
| 1168883111 | 11688831 | Haematochezia | |
| 1168883111 | 11688831 | Headache | |
| 1168883111 | 11688831 | Heart rate increased | |
| 1168883111 | 11688831 | Irritable bowel syndrome | |
| 1168883111 | 11688831 | Mood swings | |
| 1168883111 | 11688831 | Nausea | |
| 1168883111 | 11688831 | Pain | |
| 1168883111 | 11688831 | Productive cough | |
| 1168883111 | 11688831 | Pyrexia | |
| 1168883111 | 11688831 | Sinus congestion | |
| 1168883111 | 11688831 | Sinusitis | |
| 1168883111 | 11688831 | Skin plaque | |
| 1168883111 | 11688831 | Somnolence | |
| 1168883111 | 11688831 | Tooth resorption | |
| 1168883111 | 11688831 | Tremor |
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 |
|---|---|---|---|---|---|---|
| 1168883111 | 11688831 | 1 | 20140219 | 0 | ||
| 1168883111 | 11688831 | 2 | 20140828 | 0 | ||
| 1168883111 | 11688831 | 3 | 20160308 | 0 | ||
| 1168883111 | 11688831 | 4 | 20160405 | 0 | ||
| 1168883111 | 11688831 | 5 | 20160505 | 0 | ||
| 1168883111 | 11688831 | 6 | 20160628 | 0 | ||
| 1168883111 | 11688831 | 7 | 20150714 | 20150812 | 0 | |
| 1168883111 | 11688831 | 9 | 201412 | 0 |