Table 3:
Adverse Reactions (≥ 15% Incidence) in Patients Receiving Pemigatinib in FIGHT-202
| Pemigatinib N=146 | ||
|---|---|---|
| Adverse Reaction | All Gradesa (%) | Grades ≥ 3* (%) |
| Metabolism and nutrition disorders | ||
| Hyperphosphatemiab | 60 | 0 |
| Decreased appetite | 33 | 1.4 |
| Hypophosphatemiac | 23 | 12 |
| Dehydration | 15 | 3.4 |
| Skin and subcutaneous tissue disorders | ||
| Alopecia | 49 | 0 |
| Nail toxicityd | 43 | 2.1 |
| Dry skin | 20 | 0.7 |
| Palmar-plantar erythrodysesthesia syndrome | 15 | 4.1 |
| Gastrointestinal disorders | ||
| Diarrhea | 47 | 2.7 |
| Nausea | 40 | 2.1 |
| Constipation | 35 | 0.7 |
| Stomatitis | 35 | 5 |
| Dry mouth | 34 | 0 |
| Vomiting | 27 | 1.4 |
| Abdominal pain | 23 | 4.8 |
| General disorders | ||
| Fatigue | 42 | 4.8 |
| Edema peripheral | 18 | 0.7 |
| Nervous system disorders | ||
| Dysgeusia | 40 | 0 |
| Headache | 16 | 0 |
| Eye disorders | ||
| Dry eyee | 35 | 0.7 |
| Musculoskeletal and connective tissue disorders | ||
| Arthralgia | 25 | 6 |
| Back pain | 20 | 2.7 |
| Pain in extremity | 19 | 2.1 |
| Infections and infestations | ||
| Urinary tract infection | 16 | 2.7 |
| Investigations | ||
| Weight loss | 16 | 2.1 |
Source: US package insert (11).
*
Only Grades 3 – 4 were identified.
a
Graded per NCI CTCAE 4.03
b
Includes hyperphosphatemia and blood phosphorous increased; graded based on clinical severity and medical interventions taken according to the “investigations-other, specify” category in NCI CTCAE v4.03.
c
Includes hypophosphatemia and blood phosphorous decreased
d
Includes nail toxicity, nail disorder, nail discoloration, nail dystrophy, nail hypertrophy, nail ridging, nail infection, onychalgia, onychoclasis, onycholysis, onychomadesis, onychomycosis, and paronychia.
e
Includes dry eye, keratitis, lacrimation increased, pinguecula, and punctate keratitis.