tepain and injection-site erythema.
The data in Table 3 were obtained from the HannaH trial for adverse reactions that occurred in ≥ 5% of thepatients treated with HERCEPTIN HYLECTA.
Table 3
Adverse Reactions* (≥ 5% Incidence) Reported in HannaH
Adverse Reactions HERCEPTIN HYLECTA
600 mg
n=297
Intravenous Trastuzumab
(loading dose: 8 mg/kg; maintenance
dose: 6 mg/kg)
n=298
All Grades
%
Grades 3 to 5
%
All Grades
%
Grades 3 to 5
%
SKIN AND SUBCUTANEOUS TISSUE DISORDERS
Alopecia*,† 63 1.3 63 1.7
Rash*,† 26 < 1 26 -
Nail Disorder*,† 14 - 14 < 1
Pruritus*,† 9 - 9 -
Skin Discoloration* 9 - 8 -
Erythema* 7 < 1 3 -
GASTROINTESTINAL DISORDERS
Nausea 49 1.3 49 1.3
Diarrhea*,† 34 2.7 37 2.7
Vomiting† 23 1 23 1.7
Stomatitis* 21 < 1 18 < 1
Abdominal Pain*,† 14 - 14 < 1
Dyspepsia 11 - 10 -
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS
Fatigue*,† 46 < 1 49 2
Edema*,† 14 - 15 -
Pyrexia* 13 1 12 < 1
Mucosal Inflammation† 10 < 1 13 -
Pain*,† 5 - 8 < 1
Injection Site Reaction*,‡ 10 - < 1 -
BLOOD AND LYMPHATIC SYSTEM DISORDERS
Neutropenia† 44 30 47 34
Leukopenia*,† 11 5 16 8
Anemia*,† 12 < 1 14 1
Febrile Neutropenia* 6 6 4 4
INFECTIONS AND INFESTATIONS
Upper Respiratory Tract
Infection*,† 24 1 27 < 1
Urinary Tract Infection*,† 4 - 8 < 1
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS
Myalgia* 21 - 19 < 1
Arthralgia*,† 18 - 21 < 1
Back Pain* 11 1 9 1
Pain in Extremity 10 - 9 < 1
Pain*,† 8 < 1 9 -
Bone Pain 6 < 1 3.4 -
NERVOUS SYSTEM DISORDERS
Neuropathy Peripheral* 20 - 15 -
Headache* 17 < 1 15 < 1
Dizziness* 10 < 1 9 < 1
Dysgeusia* 10 - 8 -
INJURY, POISONING AND PROCEDURAL COMPLICATIONS
Incision Site Complication* 11 - 8 < 1
Pain* 6 - 5 < 1
Table 3
Adverse Reactions* (≥ 5% Incidence) Reported in HannaH
Adverse Reactions HERCEPTIN HYLECTA
600 mg
n=297
Intravenous Trastuzumab
(loading dose: 8 mg/kg; maintenance
dose: 6 mg/kg)
n=298
All Grades
%
Grades 3 to 5
%
All Grades
%
Grades 3 to 5
%
RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS
Cough* 12 < 1 8 -
Dyspnea*,† 7 - 8 -
Epistaxis 6 - 6 -
Nasal Inflammation /
Discomfort*,† 5 - 7 -
VASCULAR DISORDERS
Flushing* 14 < 1 13 < 1
Hypertension* 8 2.4 5 < 1
METABOLISM AND NUTRITION DISORDERS
Decreased Appetite 20 < 1 20 < 1
INVESTIGATIONS
Liver Function Analysis
Abnormal*,† 6 1 9 1.7
CARDIAC DISORDERS
Arrhythmia*† 5 - 5 < 1
IMMUNE SYSTEM DISORDERS
Hypersensitivity*,† 7 1 7 1.3 * Contains grouped terms
† The HannaH trial was not designed to demonstrate a statistically significant difference in adverse reaction rates between HERCEPTINHYLECTA and intravenous trastuzumab. ‡ Injection Site Reaction includes terms for injection related reaction and injection site joint pain, bruising, dermatitis, discoloration,
discomfort, erythema, extravasation, fibrosis, hematoma, hemorrhage, hypersensitivity, induration, inflammation, irritation, macule,mass, nodule, edema, pallor, paraesthesia, pruritus, rash, reaction, swelling, ulcer, vesicles and warmth.
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