nd schedule was 1.8 mg/kg intravenously every 3 weeks. Median duration of treatment was 24 weeks (range, 3 to 56 weeks) [see Clinical Studies (14)].
The most common adverse reactions (≥20%), regardless of causality, were neutropenia, anemia, peripheral sensory neuropathy, fatigue, nausea, pyrexia, rash, diarrhea, and pain.
Combined Experience
Table 1: Most Commonly Reported (≥10%) Adverse Reactions *
Derived from laboratory values and adverse reaction data
HL sALCL
Total N = 102
% of patients Total N = 58
% of patients
Adverse Reaction Any
Grade Grade
3 Grade
4 Any
Grade Grade
3 Grade
4
Blood and lymphatic system disorders
Neutropenia* 54 15 6 55 12 9
Anemia* 33 8 2 52 2 -
Thrombocytopenia* 28 7 2 16 5 5
Lymphadenopathy 11 - - 10 - -
Nervous system disorders
Peripheral sensory neuropathy 52 8 - 53 10 -
Peripheral motor neuropathy 16 4 - 7 3 -
Headache 19 - - 16 2 -
Dizziness 11 - - 16 - -
General disorders and administration site conditions
Fatigue 49 3 - 41 2 2
Pyrexia 29 2 - 38 2 -
Chills 13 - - 12 - -
Pain 7 - - 28 - 5
Edema peripheral 4 - - 16 - -
Infections and infestations
Upper respiratory tract infection 47 - - 12 - -
Gastrointestinal disorders
Nausea 42 - - 38 2 -
Diarrhea 36 1 - 29 3 -
Abdominal pain 25 2 1 9 2 -
Vomiting 22 - - 17 3 -
Constipation 16 - - 19 2 -
Skin and subcutaneous tissue disorders
Rash 27 - - 31 - -
Pruritus 17 - - 19 - -
Alopecia 13 - - 14 - -
Night sweats 12 - - 9 - -
Dry skin 4 - - 10 - -
Respiratory, thoracic and mediastinal disorders
Cough 25 - - 17 - -
Dyspnea 13 1 - 19 2 -
Oropharyngeal pain 11 - - 9 - -
Musculoskeletal and connective tissue disorders
Arthralgia 19 - - 9 - -
Myalgia 17 - - 16 2 -
Back pain 14 - - 10 2 -
Pain in extremity 10 - - 10 2 2
Muscle spasms 9 - - 10 2 -
Psychiatric disorders
Insomnia 14 - - 16 - -
Anxiety 11 2 - 7 - -
Metabolism and nutrition disorders
Decreased appetite 11 - - 16 2 -
Investigations
Weight decreased 6 - - 12 3 -
Infusion reactions
Two cases of anaphylaxis were reported in phase 1 trials. There were no Grade 3 or 4 infusion-related reactions reported in the phase 2 trials, however, Grade 1 or 2 infusion-related reactions were reported for 19 patients (12%). The most common adverse reactions (≥2%) associated with infusion-related reactions were chills (4%), nausea (3%), dyspnea (3%), pruritus (3%), pyrexia (2%), and cough (2%).
Serious adverse events
In the phase 2 trials, serious adverse reactions, regardless of causality, were reported in 31% of patients receiving ADCETRIS. The most common serious adverse reactions experienced by patients with HL include peripheral motor neuropathy (4%), abdominal pain (3%), pulmonary embolism (2%), pneumonitis (2%), pneumothorax (2%), pyelonephritis (2%), and pyrexia (2%). The most common serious adverse reactions experienced by patients with sALCL were septic shock (3%), supraventricular arrhythmia (3%), pain in extremity (3%), and urinary tract infection (3%). Other impo |
