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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125468611 | 12546861 | 1 | I | 20160628 | 20160711 | 20160711 | EXP | CA-CELGENEUS-CAN-2016066643 | CELGENE | VIEL-THERIAULT. THALIDOMIDE IN REFRACTORY TUBERCULOMAS AND PSEUDO-ABSCESSES.. PEDIATR INFECT DIS J.. 2016 JUN 21;. | 13.00 | YR | F | Y | 0.00000 | 20160711 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125468611 | 12546861 | 1 | PS | THALOMID | THALIDOMIDE | 1 | Oral | U | U | 20785 | 6 | MG/KG | CAPSULES | QD | |||||
| 125468611 | 12546861 | 2 | SS | THALOMID | THALIDOMIDE | 1 | Oral | U | U | 20785 | 2 | MG/KG | CAPSULES | QD | |||||
| 125468611 | 12546861 | 3 | SS | THALOMID | THALIDOMIDE | 1 | Oral | U | U | 20785 | 6 | MG/KG | CAPSULES | QD | |||||
| 125468611 | 12546861 | 4 | C | ISONIAZID. | ISONIAZID | 1 | Unknown | 300 MILLIGRAM | 0 | 300 | MG | UNKNOWN | |||||||
| 125468611 | 12546861 | 5 | C | Rifampicin | RIFAMPIN | 1 | Unknown | 0 | 600 | MG | UNKNOWN | ||||||||
| 125468611 | 12546861 | 6 | C | PYRAZINAMIDE. | PYRAZINAMIDE | 1 | Unknown | 600 MILLIGRAM | 0 | 1500 | MG | UNKNOWN | |||||||
| 125468611 | 12546861 | 7 | C | ETHAMBUTOL | ETHAMBUTOL HYDROCHLORIDE | 1 | Unknown | 1500 MILLIGRAM | 0 | 800 | MG | UNKNOWN | |||||||
| 125468611 | 12546861 | 8 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 800 MILLIGRAM | 0 | .4 | MG/KG | UNKNOWN | QD | ||||||
| 125468611 | 12546861 | 9 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | 5 | MG | UNKNOWN | QD | |||||||
| 125468611 | 12546861 | 10 | C | DEXAMETHASONE. | DEXAMETHASONE | 1 | Unknown | 0 | .4 | MG | UNKNOWN | QD | |||||||
| 125468611 | 12546861 | 11 | C | Ethionamide | ETHIONAMIDE | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125468611 | 12546861 | 12 | C | MOXIFLOXACIN. | MOXIFLOXACIN | 1 | Unknown | 0 | UNKNOWN | ||||||||||
| 125468611 | 12546861 | 13 | C | PREGABALIN. | PREGABALIN | 1 | Unknown | 0 | UNKNOWN |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125468611 | 12546861 | 1 | Tuberculoma of central nervous system |
| 125468611 | 12546861 | 2 | Abscess |
| 125468611 | 12546861 | 4 | Tuberculosis |
| 125468611 | 12546861 | 5 | Tuberculosis |
| 125468611 | 12546861 | 6 | Tuberculosis |
| 125468611 | 12546861 | 7 | Tuberculosis |
| 125468611 | 12546861 | 8 | Tuberculosis |
| 125468611 | 12546861 | 11 | Tuberculosis |
| 125468611 | 12546861 | 12 | Tuberculosis |
| 125468611 | 12546861 | 13 | Paraesthesia |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125468611 | 12546861 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125468611 | 12546861 | Brain oedema | |
| 125468611 | 12546861 | Epilepsy | |
| 125468611 | 12546861 | Memory impairment | |
| 125468611 | 12546861 | Optic neuropathy | |
| 125468611 | 12546861 | Paraesthesia | |
| 125468611 | 12546861 | Seizure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |