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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1109967921 | 11099679 | 21 | F | 201208 | 20160829 | 20150508 | 20160901 | EXP | MX-ROCHE-1407562 | ROCHE | 66.93 | YR | F | Y | 36.00000 | KG | 20160901 | CN | MX | MX |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1109967921 | 11099679 | 1 | PS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 1000 MG AND BOOSTER DOSE OF 1000 MG AFTER 15 DAYS | U | N | 103705 | 2000 | MG | SOLUTION FOR INFUSION | |||||
| 1109967921 | 11099679 | 2 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 500 MG AND BOOSTER DOSE OF 500 MG AFTER 15 DAYS | U | N | 103705 | 1000 | MG | SOLUTION FOR INFUSION | |||||
| 1109967921 | 11099679 | 3 | SS | MABTHERA | RITUXIMAB | 1 | Intravenous (not otherwise specified) | 1000 MG AND BOOSTER DOSE OF 1000 MG AFTER 15 DAYS | U | N | 103705 | 2000 | MG | SOLUTION FOR INFUSION | |||||
| 1109967921 | 11099679 | 4 | C | DICLOFENAC | DICLOFENAC | 1 | Oral | EVERY 8 HOURS FOR 5 DAYS | 0 | Q8H | |||||||||
| 1109967921 | 11099679 | 5 | C | AZULFIDINE | SULFASALAZINE | 1 | Oral | 6 TABLETS (2-2-2) | 0 | TABLET | QD | ||||||||
| 1109967921 | 11099679 | 6 | C | AZULFIDINE | SULFASALAZINE | 1 | Oral | 3 TABLETS (1-1-1) | 0 | QD | |||||||||
| 1109967921 | 11099679 | 7 | C | METHOTREXATE. | METHOTREXATE | 1 | Oral | 2 TABLETS (1-0-1) | 0 | TABLET | QD | ||||||||
| 1109967921 | 11099679 | 8 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | EVERY 8 HOURS FOR 5 DAYS | 0 | Q8H | |||||||||
| 1109967921 | 11099679 | 9 | C | CARBAFEN | 2 | Oral | EVERY 8 HOURS FOR 5 DAYS. | 0 | Q8H |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 1109967921 | 11099679 | 1 | Rheumatoid arthritis |
| 1109967921 | 11099679 | 4 | Pain |
| 1109967921 | 11099679 | 5 | Rheumatoid arthritis |
| 1109967921 | 11099679 | 7 | Rheumatoid arthritis |
| 1109967921 | 11099679 | 8 | Pain |
| 1109967921 | 11099679 | 9 | Pain |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 1109967921 | 11099679 | HO |
| 1109967921 | 11099679 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 1109967921 | 11099679 | Abdominal distension | |
| 1109967921 | 11099679 | Abdominal pain | |
| 1109967921 | 11099679 | Anxiety | |
| 1109967921 | 11099679 | Arthralgia | |
| 1109967921 | 11099679 | Asthenia | |
| 1109967921 | 11099679 | Chest pain | |
| 1109967921 | 11099679 | Constipation | |
| 1109967921 | 11099679 | Diarrhoea | |
| 1109967921 | 11099679 | Fall | |
| 1109967921 | 11099679 | Fatigue | |
| 1109967921 | 11099679 | Flatulence | |
| 1109967921 | 11099679 | Gait disturbance | |
| 1109967921 | 11099679 | Gastrointestinal sounds abnormal | |
| 1109967921 | 11099679 | Gluten sensitivity | |
| 1109967921 | 11099679 | Lymphoma | |
| 1109967921 | 11099679 | Muscle spasms | |
| 1109967921 | 11099679 | Musculoskeletal pain | |
| 1109967921 | 11099679 | Myalgia | |
| 1109967921 | 11099679 | Nasopharyngitis | |
| 1109967921 | 11099679 | Nervous system disorder | |
| 1109967921 | 11099679 | Neuritis | |
| 1109967921 | 11099679 | Nodule | |
| 1109967921 | 11099679 | Pain | |
| 1109967921 | 11099679 | Pain in extremity | |
| 1109967921 | 11099679 | Paraesthesia | |
| 1109967921 | 11099679 | Peripheral swelling | |
| 1109967921 | 11099679 | Post procedural haematoma | |
| 1109967921 | 11099679 | Postoperative abscess | |
| 1109967921 | 11099679 | Procedural pain | |
| 1109967921 | 11099679 | Pulmonary mass | |
| 1109967921 | 11099679 | Scoliosis | |
| 1109967921 | 11099679 | Spinal pain | |
| 1109967921 | 11099679 | Tendon rupture | |
| 1109967921 | 11099679 | Throat irritation | |
| 1109967921 | 11099679 | Urticaria | |
| 1109967921 | 11099679 | Vomiting | |
| 1109967921 | 11099679 | 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 |
|---|---|---|---|---|---|---|
| 1109967921 | 11099679 | 1 | 201104 | 201204 | 0 | |
| 1109967921 | 11099679 | 2 | 201204 | 20141121 | 0 | |
| 1109967921 | 11099679 | 3 | 20141121 | 0 | ||
| 1109967921 | 11099679 | 5 | 2004 | 2004 | 0 | |
| 1109967921 | 11099679 | 6 | 2004 | 2011 | 0 | |
| 1109967921 | 11099679 | 7 | 2004 | 2011 | 0 |