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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124665207 | 12466520 | 7 | F | 20160414 | 20160915 | 20160615 | 20160919 | EXP | CA-ROCHE-1743001 | ROCHE | 24.97 | YR | F | Y | 0.00000 | 20160919 | OT | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 124665207 | 12466520 | 1 | PS | ACTEMRA | TOCILIZUMAB | 1 | Intravenous (not otherwise specified) | B2041B22,B2051B07,B2044B08,B2052B07 | 125276 | 440 | MG | SOLUTION FOR INFUSION | |||||||
| 124665207 | 12466520 | 2 | SS | ACTEMRA | TOCILIZUMAB | 1 | B2041B22,B2051B07,B2044B08,B2052B07 | 125276 | |||||||||||
| 124665207 | 12466520 | 3 | SS | TOPIRAMATE. | TOPIRAMATE | 1 | Unknown | D | 0 | ||||||||||
| 124665207 | 12466520 | 4 | SS | ACETYLSALICYLIC ACID | ASPIRIN | 1 | Unknown | D | 0 | ||||||||||
| 124665207 | 12466520 | 5 | SS | ADVIL | IBUPROFEN | 1 | Unknown | D | 0 | ||||||||||
| 124665207 | 12466520 | 6 | C | PREDNISONE. | PREDNISONE | 1 | 0 | ||||||||||||
| 124665207 | 12466520 | 7 | C | PANTOLOC | PANTOPRAZOLE SODIUM | 1 | 0 | ||||||||||||
| 124665207 | 12466520 | 8 | C | ASPIRIN. | ASPIRIN | 1 | 0 | ||||||||||||
| 124665207 | 12466520 | 9 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | 0 | 50 | MG | BID | ||||||||
| 124665207 | 12466520 | 10 | C | METOPROLOL. | METOPROLOL | 1 | Unknown | 0 | 50 | MG | |||||||||
| 124665207 | 12466520 | 11 | C | COVERSYL | PERINDOPRIL | 1 | 0 | ||||||||||||
| 124665207 | 12466520 | 12 | C | AMLODIPINE | AMLODIPINE BESYLATE | 1 | Unknown | 0 | 5 | MG | QD | ||||||||
| 124665207 | 12466520 | 13 | C | FOLIC ACID. | FOLIC ACID | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 124665207 | 12466520 | 1 | Vasculitis |
| 124665207 | 12466520 | 2 | Takayasu's arteritis |
| 124665207 | 12466520 | 3 | Headache |
| 124665207 | 12466520 | 4 | Product used for unknown indication |
| 124665207 | 12466520 | 5 | Product used for unknown indication |
| 124665207 | 12466520 | 9 | Hypertension |
| 124665207 | 12466520 | 11 | Hypertension |
| 124665207 | 12466520 | 12 | Hypertension |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 124665207 | 12466520 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 124665207 | 12466520 | Abdominal pain | |
| 124665207 | 12466520 | Abdominal pain upper | |
| 124665207 | 12466520 | Blood pressure diastolic increased | |
| 124665207 | 12466520 | Blood pressure fluctuation | |
| 124665207 | 12466520 | Blood pressure increased | |
| 124665207 | 12466520 | Chills | |
| 124665207 | 12466520 | Diarrhoea | |
| 124665207 | 12466520 | Diarrhoea haemorrhagic | |
| 124665207 | 12466520 | Hypersensitivity | |
| 124665207 | 12466520 | Hypotension | |
| 124665207 | 12466520 | Infusion related reaction | |
| 124665207 | 12466520 | Lip swelling | |
| 124665207 | 12466520 | Musculoskeletal pain | |
| 124665207 | 12466520 | Nausea | |
| 124665207 | 12466520 | Neck pain | |
| 124665207 | 12466520 | Pruritus | |
| 124665207 | 12466520 | Rectal haemorrhage | |
| 124665207 | 12466520 | Swelling face | |
| 124665207 | 12466520 | Swollen tongue | |
| 124665207 | 12466520 | Throat tightness | |
| 124665207 | 12466520 | Vasculitis | |
| 124665207 | 12466520 | Vomiting | |
| 124665207 | 12466520 | Weight decreased |
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 |
|---|---|---|---|---|---|---|
| 124665207 | 12466520 | 1 | 20160414 | 0 | ||
| 124665207 | 12466520 | 3 | 20160603 | 0 |