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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118093835 | 11809383 | 5 | F | 20141209 | 20160908 | 20151207 | 20160912 | EXP | CA-ROCHE-1506267 | ROCHE | 69.63 | YR | F | Y | 0.00000 | 20160912 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 118093835 | 11809383 | 1 | PS | RITUXAN | RITUXIMAB | 1 | Intravenous (not otherwise specified) | FREQUENCY: DAY 1 AND DAY 15 AND ON 23/DEC/2014- DATE OF MOST RECENT DOSE. | H0736B04,N3708B01,N3722 | 103705 | 1000 | MG | SOLUTION FOR INFUSION | ||||||
| 118093835 | 11809383 | 2 | SS | DAPSONE. | DAPSONE | 1 | Unknown | U | 0 | 50 | MG | QD | |||||||
| 118093835 | 11809383 | 3 | C | DIPHENHYDRAMINE HCL | DIPHENHYDRAMINE HYDROCHLORIDE | 1 | Oral | 0 | 50 | MG | |||||||||
| 118093835 | 11809383 | 4 | C | ACETAMINOPHEN. | ACETAMINOPHEN | 1 | Oral | 0 | 650 | MG | |||||||||
| 118093835 | 11809383 | 5 | C | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 0 | 100 | MG | |||||||||
| 118093835 | 11809383 | 6 | C | MYFORTIC | MYCOPHENOLATE SODIUM | 1 | Unknown | 0 | 720 | MG | BID | ||||||||
| 118093835 | 11809383 | 7 | C | SYNTHROID | LEVOTHYROXINE SODIUM | 1 | 0 | ||||||||||||
| 118093835 | 11809383 | 8 | C | VITAMIN B12 | CYANOCOBALAMIN | 1 | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 118093835 | 11809383 | 1 | Pemphigoid |
| 118093835 | 11809383 | 2 | Product used for unknown indication |
| 118093835 | 11809383 | 3 | Premedication |
| 118093835 | 11809383 | 4 | Premedication |
| 118093835 | 11809383 | 5 | Premedication |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 118093835 | 11809383 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 118093835 | 11809383 | Angina bullosa haemorrhagica | |
| 118093835 | 11809383 | Anxiety | |
| 118093835 | 11809383 | Blood pressure increased | |
| 118093835 | 11809383 | Blood pressure systolic increased | |
| 118093835 | 11809383 | Bronchitis | |
| 118093835 | 11809383 | Cardiac flutter | |
| 118093835 | 11809383 | Dacryostenosis acquired | |
| 118093835 | 11809383 | Feeling hot | |
| 118093835 | 11809383 | Haemoglobin decreased | |
| 118093835 | 11809383 | Infusion related reaction | |
| 118093835 | 11809383 | Off label use | |
| 118093835 | 11809383 | Pemphigoid | |
| 118093835 | 11809383 | Pemphigus | |
| 118093835 | 11809383 | Stress |
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 |
|---|---|---|---|---|---|---|
| 118093835 | 11809383 | 1 | 20141209 | 0 | ||
| 118093835 | 11809383 | 3 | 20141209 | 0 | ||
| 118093835 | 11809383 | 4 | 20141209 | 0 | ||
| 118093835 | 11809383 | 5 | 20141209 | 0 |