Table 4.
Incidence of Symptomatic Adverse Events in the Induction Phase
| Category | Adverse event | Protocol-infusion | ||
|---|---|---|---|---|
| Edmonton- 1st (n = 4) |
Edmonton- 2nd (n = 4) |
TCD-AI- 1st (n = 4) |
||
| Allergy/immunology | Allergic rhinitis | 0 | 1 | 2 |
| Cardiac-general | Hypertension | 0 | 1 | 0 |
| Cardiac ischemia/infarction | 0 | 0 | 1a | |
| Constitutional symptoms | Fatigue | 3 | 2 | 3 |
| Insomnia | 1 | 1 | 2 | |
| Weight loss | 2 | 1 | 2 | |
| Rigors/chills | 0 | 1 | 0 | |
| Dermatology | Bruisingc | 2 | 3 | 0 |
| Flushing | 1 | 0 | 0 | |
| Pruritus | 0 | 1 | 0 | |
| Rashd | 1 | 3 | 0 | |
| Acne | 0 | 0 | 1 | |
| Alopecia | 1 | 0 | 0 | |
| Gastrointestinal | Anorexia | 0 | 0 | 1 |
| Mucositis (functional/symptomatic)—stomach | 3 | 1 | 1 | |
| Diarrhea | 2 | 2 | 0 | |
| Nausea | 3 | 3 | 1 | |
| Mouth ulcerb | 4 | 4 | 0 | |
| Vomiting | 2 | 1 | 3 | |
| Lymphatics | Edema: limb | 0 | 2 | 0 |
| Neurology | Mood alteration—anxiety | 0 | 0 | 1 |
| Dizziness | 0 | 0 | 1 | |
| Tremor | 0 | 1 | 0 | |
| Pain | Headache | 0 | 0 | 2 |
| Throat/pharynx/larynx | 1 | 1 | 0 | |
| Extremity-limb | 3 | 3 | 1 | |
| Renal-genitourinary | Urinary frequency/urgency | 0 | 1 | 0 |
a
High-grade adverse event.
b
p < 0.01 for TCD-AI-1st versus Edmonton-1st and -2nd groups.
c
p = 0.09 between TCD-AI-1st and Edmonton-2nd group.
d
p = 0.07 between TCD-AI-1st and Edmonton-2nd group.