p;Grades 3 and 4
% All Grades
% Grades 3 and 4
%
National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03.
Grades 1 through 5 are included in All Grades.
One Grade 5 (fatal) event in the VIZIMPRO arm.
Stomatitis includes mucosal inflammation and stomatitis.
Rash includes dermatitis acneiform, rash, and rash maculo-papular.
Paronychia includes nail infection, nail toxicity, onychoclasis, onycholysis, onychomadesis, paronychia.
Dry skin includes dry skin, xerosis.
Pruritus includes pruritus, pruritus generalized, rash pruritic.
Nasal mucosal disorder includes epistaxis, nasal inflammation, nasal mucosal disorder, nasal mucosal ulcer, rhinitis.
Gastrointestinal
Diarrhea‡ 87 8 56 0.9
Stomatitis§ 45 4.4 19 0.4
Nausea 19 1.3 22 0.4
Constipation 13 0 14 0
Mouth ulceration 12 0 6 0
Skin and Subcutaneous Tissue
Rash¶ 69 23 47 0.4
Paronychia# 64 8 21 1.3
Dry skinÞ 30 1.8 19 0.4
Alopecia 23 0.4 13 0
Pruritusß 21 0.9 15 1.3
Palmar-plantar erythrodysesthesia syndrome 15 0.9 3.1 0
Dermatitis 11 1.8 4 0.4
Metabolism and Nutrition
Decreased appetite 31 3.1 25 0.4
Decreased weight 26 2.2 17 0.4
Respiratory
Cough 21 0 19 0.4
Nasal mucosal disorderà 19 0 4.9 0
Dyspnea 13 2.2 13 1.8
Upper respiratory tract infection 12 1.3 13 0
Chest pain 10 0 14 0
Eye
Conjunctivitis 19 0 4 0
Musculoskeletal
Pain in extremity 14 0 12 0
Musculoskeletal pain 12 0.9 13 0
General
Asthenia 13 2.2 13 1.3
Psychiatric
Insomnia 11 0.4 15 0
Additional adverse reactions (All Grades) that were reported in <10% of patients who received VIZIMPRO in ARCHER 1050 include:
General: fatigue 9%
Skin and subcutaneous tissue: skin fissures 9%, hypertrichosis 1.3%, skin exfoliation/exfoliative skin reactions 3.5%
Gastrointestinal: vomiting 9%
Nervous system: dysgeusia 7%
Respiratory: interstitial lung disease 2.6%
Ocular: keratitis 1.8%
Metabolism and nutrition: dehydration 1.3%
Table 4. Laboratory Abnormalities Worsening from Baseline in >20% of Patients in ARCHER 1050*
Laboratory Test Abnormality† VIZIMPRO Gefitinib
Change from Baseline All Grades
(%) Change from Baseline to Grade 3 or Grade 4
(%) Change from Baseline All Grades
(%) Change from Baseline to Grade 3 or Grade 4
(%)
ALT=alanine aminotransferase; AST=aspartate aminotransferase.
NCI CTCAE v4.03, except for increased creatinine which only includes patients with creatinine increase based on upper limit of normal definition.
Based on the number of patients with available baseline and at least one on-treatment laboratory test.
Hematology
Anemia 44 0.9 26 2.7
Lymphopenia 42 6 |
