Adverse events observed during the first 6 weeks of therapy
| . | Total no. grades 3/4 adverse events . | All adverse events likely related to IT combination . |
|---|---|---|
| Allergy/immunology | 0 | 15-151 |
| Auditory/hearing | 0 | 0 |
| Blood/bone marrow | 0 | 0 |
| Cardiovascular | 0 | 15-152 |
| Coagulation | 15-153 | 0 |
| Constitutional symptoms | 25-155 | 15-151 |
| Dermatology/skin | 0 | 0 |
| Endocrine | 0 | 0 |
| Gastrointestinal | 0 | 0 |
| Hemorrhage | 0 | 0 |
| Hepatic | 15-154 | 0 |
| Infection/febrile neutropenia | 2# | 0 |
| Lymphatics | 0 | 0 |
| Metabolic/laboratory | 0 | 0 |
| Musculoskeletal | 0 | 15-160 |
| Neurology | 15-164 | 0 |
| Ocular/visual | 0 | 0 |
| Pain | 0 | 0 |
| Pulmonary | 0 | 0 |
| Renal/genitourinary | 0 | 0 |
| Sexual/reproductive | 0 | 0 |
| Syndromes | 0 | 0 |
| . | Total no. grades 3/4 adverse events . | All adverse events likely related to IT combination . |
|---|---|---|
| Allergy/immunology | 0 | 15-151 |
| Auditory/hearing | 0 | 0 |
| Blood/bone marrow | 0 | 0 |
| Cardiovascular | 0 | 15-152 |
| Coagulation | 15-153 | 0 |
| Constitutional symptoms | 25-155 | 15-151 |
| Dermatology/skin | 0 | 0 |
| Endocrine | 0 | 0 |
| Gastrointestinal | 0 | 0 |
| Hemorrhage | 0 | 0 |
| Hepatic | 15-154 | 0 |
| Infection/febrile neutropenia | 2# | 0 |
| Lymphatics | 0 | 0 |
| Metabolic/laboratory | 0 | 0 |
| Musculoskeletal | 0 | 15-160 |
| Neurology | 15-164 | 0 |
| Ocular/visual | 0 | 0 |
| Pain | 0 | 0 |
| Pulmonary | 0 | 0 |
| Renal/genitourinary | 0 | 0 |
| Sexual/reproductive | 0 | 0 |
| Syndromes | 0 | 0 |
NCI-CTC criteria (version 2.0), using the bone marrow transplantation-specific scaling when applicable.
Episodes of fever during and between infusions.
Limited capillary leakage.
TTP.
40% decrease Karnofsky (n = 2).
Transient rise of SGOT & SGPT (after day 24).
#Aspergillosis, CMV-infection.
Rise in CK levels to 1.45 times upper normal value.
Transient aphasia (<1 hour), probably related to TTP.