Table 3 Listing of TRAEs in two studies.
PT | Site | 0 ~ 24 h | Day 2 ~ 7 | Day 8 ~ 14 | Day 15 ~ 21 | Day 22 ~ 63 | Relationship to Study Medication | Action Taken with | Outcome |
|---|---|---|---|---|---|---|---|---|---|
(Severity of AE) | Study Treatment | ||||||||
0.01 mg/kg | China | Oral mucositis | Possible | None | Resolved | ||||
(Grade 1) | |||||||||
Limbs pain | Probable | None | Resolved | ||||||
(Grade 1) | |||||||||
0.04 mg/kg | China | Lymph node pain | Possible | None | Resolved | ||||
(Grade 1) | |||||||||
New Zealand | Nasal congestion | Possible | None | Resolved | |||||
(Grade 1) | |||||||||
0.12 mg/kg | China | Diarrhea | Possible | None | Resolved | ||||
(Grade 1) | |||||||||
Elevated alanine aminotransferase | Probable | None | Resolved | ||||||
(Grade 1) | |||||||||
Elevated aspartate aminotransferase | Probable | None | Resolved | ||||||
(Grade 1) | |||||||||
New Zealand | Fatigue | Possible | None | Resolving | |||||
(Grade 1) | |||||||||
0.25 mg/kg | China | Bacterial infections | Probable | None | Resolved | ||||
(Grade 1) | |||||||||
Elevated alanine aminotransferase | Probable | None | Resolved | ||||||
(Grade 1) | |||||||||
Elevated blood uric acid | Possible | None | Resolved | ||||||
(Grade 1) | |||||||||
Elevated gamma-glutamyl transpeptidase | Possible | None | Resolved | ||||||
(Grade 1) | |||||||||
Decreased lymphocyte count (Grade 2) | Possible | None | Resolved | ||||||
New Zealand | Vulvovaginal candidiasis | Possible | None | Resolved | |||||
(Grade 1) | |||||||||
Limb discomfort | Possible | None | Resolved | ||||||
(Grade 1) | |||||||||
Diarrhea | Possible | None | Resolved | ||||||
(Grade 2) | |||||||||
Rash | Possible | None | Resolved | ||||||
(Grade 1) | |||||||||
0.40 mg/kg | New Zealand | Infusion related reaction (Grade 2) | Definite | Medication | Resolved | ||||
Deranged liver blood testsa | Probable | None | Resolved | ||||||
(Grade 3) |
