Table 5.
Incidence of Symptomatic Adverse Events in the Maintenance Phase
| Category | Adverse event | Protocol-infusion | ||
|---|---|---|---|---|
| Edmonton- 1st (n = 3) |
Edmonton- 2nd (n = 3) |
TCD- AI-1st (n = 4) |
||
| Allergy/immunology | Allergic rhinitis | 0 | 1 | 2 |
| Cardiac-general | Hypertension | 0 | 0 | 1 |
| Constitutional symptoms | Fatigue | 1 | 2 | 2 |
| Insomnia | 1 | 0 | 1 | |
| Weight loss | 0 | 0 | 1 | |
| Weight gain | 0 | 1 | 0 | |
| Rigors/chills | 0 | 1 | 0 | |
| Fever | 0 | 2 | 0 | |
| Dermatology | Bruising | 2 | 0 | 0 |
| Pruritus | 0 | 1 | 0 | |
| Rash | 1 | 2 | 1 | |
| Acne | 1 | 1 | 0 | |
| Wound complication, noninfection | 1 | 1 | 0 | |
| Hypopigmentation | 1 | 0 | 0 | |
| Gastrointestinal | Anorexia | 2 | 1 | 1 |
| Mucositis (functional/symptomatic)–stomach | 0 | 2 | 0 | |
| Diarrhea | 2 | 1a | 1 | |
| Nausea | 1 | 2 | 0 | |
| Mouth ulcerb | 3 | 2 | 0 | |
| Ileus | 0 | 0 | 1a | |
| Infection | Upper respiratory infection | 1 | 0 | 1 |
| Lymphatics | Edema: limbc | 3 | 3 | 1 |
| Neurology | Mood alteration–anxiety, depression | 1 | 0 | 1 |
| Dizziness | 1 | 0 | 1 | |
| Tremor | 0 | 1 | 1 | |
| Numbness | 0 | 1 | 1 | |
| Pain | Headache | 0 | 0 | 1 |
| Extremity-limb | 2 | 1 | 3 | |
| Sexual reproductive function | Irregular menses | 0 | 0 | 1 |
a
High-grade adverse event.
b
p = 0.03 for TCD-AI-1st vs. Edmonton-1st groups.
c
p = 0.09 for TCD-AI-1st vs. Edmonton-1st and -2nd groups.