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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126925541 | 12692554 | 1 | I | 20160816 | 20160829 | 20160829 | EXP | IT-CIPLA LTD.-2016IT17636 | CIPLA | FABBIANI M, MONDI A, COLAFIGLI M, D^ETTORRE G, PAOLETTI F, D^AVINO A, ET AL.. SAFETY AND EFFICACY OF TREATMENT SWITCH TO RALTEGRAVIR PLUS TENOFOVIR/EMTRICITABINE OR ABACAVIR/LAMIVUDINE IN PATIENTS WITH OPTIMAL VIROLOGICAL CONTROL: 48-WEEK RESULTS FROM A RANDOMIZED PILOT STUDY (RALTEGRAVIR SWITCH FOR TOXICITY OR ADVERSE EVENTS, RASTA STUDY). SCANDINAVIAN JOURNAL OF INFECTIOUS DISEASES. 2014;46:34 TO 45 | 0.00 | Y | 0.00000 | 20160829 | OT | IT | IT |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126925541 | 12692554 | 1 | PS | Tenofovir | TENOFOVIR | 1 | Unknown | 245 MG, QD | U | 78800 | 245 | MG | QD | ||||||
| 126925541 | 12692554 | 2 | SS | Emtricitabine | EMTRICITABINE | 1 | Unknown | 200 MG, QD | U | 0 | 200 | MG | QD | ||||||
| 126925541 | 12692554 | 3 | SS | ABACAVIR. | ABACAVIR | 1 | Unknown | 600 MG, QD | U | 0 | 600 | MG | QD | ||||||
| 126925541 | 12692554 | 4 | SS | LAMIVUDINE. | LAMIVUDINE | 1 | Unknown | 300 MG, QD | U | 0 | 300 | MG | QD | ||||||
| 126925541 | 12692554 | 5 | SS | RALTEGRAVIR. | RALTEGRAVIR | 1 | Unknown | 400 MG, BID | U | 0 | 400 | MG | BID | ||||||
| 126925541 | 12692554 | 6 | SS | RALTEGRAVIR. | RALTEGRAVIR | 1 | Unknown | UNK | U | 0 |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126925541 | 12692554 | 1 | Antiretroviral therapy |
| 126925541 | 12692554 | 2 | Antiretroviral therapy |
| 126925541 | 12692554 | 3 | Antiretroviral therapy |
| 126925541 | 12692554 | 4 | Antiretroviral therapy |
| 126925541 | 12692554 | 5 | Antiretroviral therapy |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126925541 | 12692554 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126925541 | 12692554 | Rash | |
| 126925541 | 12692554 | Renal tubular dysfunction | |
| 126925541 | 12692554 | Treatment failure |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |