Strategy for safety monitoring and follow up for ICT
| . | DFX . | DFP . | DFO . |
|---|---|---|---|
| Adverse effects | Gastrointestinal disturbances | Gastrointestinal | Auditory |
| Gastrointestinal bleeding | Neutropenia/agranulocytosis | Ophthalmologic (retinal) | |
| Increase in serum creatinine | Arthralgia | Reactions at site of infusion | |
| Rash | Increase in liver enzymes | Delay in bone growth | |
| Increase in liver enzymes | — | Yersinia infection | |
| Liver failure | — | — | |
| Renal insufficiency | — | — | |
| CBC with differential | Baseline and monthly | Baseline and weekly* | Baseline and monthly |
| Serum creatinine† | Baseline, weekly during the first month of therapy, then monthly | — | Baseline and monthly |
| Serum electrolytes | Baseline and every 1-3 mo | — | Baseline and every 1-3 mo |
| Urinalysis | Baseline and every 1-3 mo | — | — |
| Urine protein/creatinine | Baseline and monthly | — | — |
| Serum ALT, AST, and bilirubin | Baseline, every 2 wk during the first month, then monthly | Baseline and monthly | Baseline and monthly |
| Ophthalmic plus auditory examination | Baseline and yearly | — | Baseline and yearly |
| . | DFX . | DFP . | DFO . |
|---|---|---|---|
| Adverse effects | Gastrointestinal disturbances | Gastrointestinal | Auditory |
| Gastrointestinal bleeding | Neutropenia/agranulocytosis | Ophthalmologic (retinal) | |
| Increase in serum creatinine | Arthralgia | Reactions at site of infusion | |
| Rash | Increase in liver enzymes | Delay in bone growth | |
| Increase in liver enzymes | — | Yersinia infection | |
| Liver failure | — | — | |
| Renal insufficiency | — | — | |
| CBC with differential | Baseline and monthly | Baseline and weekly* | Baseline and monthly |
| Serum creatinine† | Baseline, weekly during the first month of therapy, then monthly | — | Baseline and monthly |
| Serum electrolytes | Baseline and every 1-3 mo | — | Baseline and every 1-3 mo |
| Urinalysis | Baseline and every 1-3 mo | — | — |
| Urine protein/creatinine | Baseline and monthly | — | — |
| Serum ALT, AST, and bilirubin | Baseline, every 2 wk during the first month, then monthly | Baseline and monthly | Baseline and monthly |
| Ophthalmic plus auditory examination | Baseline and yearly | — | Baseline and yearly |