remainder of the treatment.
All Systems, Any Adverse Reaction 94.8 96.4 88.5
Blood and Lymphatic System Disorder 10.4 1.8 15.4
Anemia 1.7 0.0 7.7
Cardiac Disorders 17.4 12.5 19.2
Tachycardia 3.5 10.7 19.2
Gastrointestinal Disorders 41.7 41.1 34.6
Abdominal Pain 7.0 3.6 11.5
Diarrhea 17.4 7.1 15.4
Nausea 3.5 3.6 7.7
Vomiting 7.8 10.7 11.5
General Disorders and Administration Site Conditions 47.0 58.9 42.3
Chills 10.4 12.5 7.7
Edema 2.6 3.6 7.7
Mucosal Inflammation 10.4 3.6 3.8
Pyrexia 28.7 30.4 23.1
Immune System Disorders 7.0 7.1 11.5
Graft Versus Host Disease 0.9 3.6 7.7
Infections and Infestations 40.0 30.4 34.6
Central Line Infection 0.9 8.9 0.0
Investigations 54.8 41.1 50.0
Alanine Aminotransferase Increased 13.9 5.4 11.5
Aspartate Aminotransferase Increased 16.5 1.8 11.5
Blood Potassium Decreased 18.3 8.9 26.9
Blood Potassium Increased 2.6 0.0 7.7
Protein Total Decreased 0.0 0.0 7.7
Metabolism and Nutrition Disorders 21.7 10.7 23.1
Hypokalemia 7.8 5.4 3.8
Musculoskeletal and Connective Tissue Disorders 11.3 14.3 11.5
Back Pain 3.5 0.0 7.7
Nervous System Disorders 13.0 16.1 7.7
Headache 5.2 8.9 3.8
Respiratory, Thoracic and Mediastinal Disorders 42.6 32.1 26.9
Cough 6.1 8.9 7.7
Respiratory Distress 7.8 0.0 3.8
Skin and Subcutaneous Tissue Disorders 33.0 41.1 38.5
Erythema 3.5 8.9 0.0
Pruritus 7.0 5.4 7.7
Rash 6.1 23.2 7.7
Vascular Disorders 24.3 21.4 19.2
Hypertension 9.6 8.9 3.8
Hypotension 12.2 8.9 7.7
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5
An infusion-related adverse reaction was defined as a systemic event, such as pyrexia, chills, flushing, hypotension, hypertension, tachycardia, dyspnea, tachypnea, rash, or anaphylaxis, that developed during the study therapy infusion and one hour following infusion.
6.3 Overall Safety Experience of CANCIDAS in Clinical Trials
The overall safety of CANCIDAS was assessed in 1832 individuals (including 1438 adult or pediatric patients and 394 volunteers) from 33 clinical studies. These individuals received single or multiple (once daily) doses of CANCIDAS, ranging from 5 mg to 210 mg. Full safety data is available from 1747 individuals, as the safety data from 85 patients enrolled in 2 compassionate use studies was limited solely to serious adverse reactions. Treatment emergent adverse reactions, regardless of causality, which occurred in ≥5% of all individuals who received CANCIDAS in these trials, are shown in Table 6.
Overall, 1496 of the 1747 (85.6%) patients/volunteers who received CANCIDAS experienced an adverse reaction.
TABLE 6: Treatment-Emergent * Adverse Reactions in Patients Who Received CANCIDAS in Clinical Trials † — Incidence ≥5% for at Least One Treatment Group by System Organ Class or Preferred Term Adverse Reaction‡
(MedDRA v10 System Organ Class and Preferred Term) CANCIDAS
(N = 1747)
n (%)
*
De
