Research Article
NCCAM/NCI Phase 1 Study of Mistletoe Extract and Gemcitabine in Patients with Advanced Solid Tumors
Table 3
Nonhematologic CTCAE adverse events at least possibly related to mistletoe (
).
| | Nonhematologic adverse events |
Number of events (possibly multiple same events from participant) |
Number of participants experiencing (multiple) events |
Number of participants (with most severe event if there are multiple) | | Grade 1 | Grade 2 | Grade 3 | Total | Grade 1 | Grade 2 | Grade 3 |
| | Injection site reaction | 30 | 12 | | 42 | 26 | 14 | 12 | | | Fever (in the absence of neutropenia) | 18 | 4 | | 22 | 14 | 11 | 3 | | | Induration/fibrosis skin and subcutaneous tissue | 13 | 7 | | 20 | 15 | 8 | 7 | | | Flu-like syndrome | 6 | 4 | | 10 | 9 | 5 | 4 | | | Pruritus | 3 | 1 | | 4 | 3 | 2 | 1 | | | Cellulitis (with normal ANC or grade 1 or 2 ANC) | | 1 | 1 | 2 | 2 | | 1 | 1 | | Allergic reaction/hypersensitivity | | 1 | | 1 | 1 | | 1 | | | Dermatology skin reaction-NOS | | 1 | | 1 | 1 | | 1 | | | Cellulitis with unknown ANC | | | 1 | 1 | 1 | | | 1 | | Lymphatics-NOS | 1 | | | 1 | 1 | 1 | | | | Lymphedema | | 1 | | 1 | 1 | | 1 | | | Myalgia NOS | 1 | | | 1 | 1 | 1 | | | | Pain-joint | | 1 | | 1 | 1 | | 1 | | | Pain-skin | 1 | | | 1 | 1 | 1 | | | | Phlebitis | | 1 | | 1 | 1 | | 1 | | | Rash: erythema multiforme | | 1 | | 1 | 1 | | 1 | | | Rigors/chills | 1 | | | 1 | 1 | 1 | | | | Total nonheme AEs | 75 | 35 | 2 | 112 | | | | |
|
|
NOS: not otherwise specified.
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