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. Author manuscript; available in PMC: 2022 Dec 13.
Published in final edited form as: Clin Cancer Res. 2022 Jun 13;28(12):2646–2656. doi: 10.1158/1078-0432.CCR-21-0645

Table 2.

Adverse Events Considered At Least Possibly Related to Lenalidomide (Phase I and II)

Organ System / Adverse Event Severity Grade Number of Occurrences TOTAL
1 2 3 4 5
Blood and Lymphatic System Disorders Anemia 16 1 17
Neutropenia 6 1 7
Other (increased platelets) 1 1
Cardiac Disorders Chest Pain - Cardiac 1 1
Ear and Labyrinth Disorders Tinnitus 2 2
Eye Disorders Conjunctivitis 1 1
Dry Eye 1 1
Other (vision changes) 2 2
Gastrointestinal Disorders Abdominal Distension 1 1
Abdominal Pain 2 2
Bloating 1 1
Constipation 5 1 6
Diarrhea 11 7 1 19
Dry Mouth 2 2
Dyspepsia 3 3
Gastroesophageal Reflux Disease 1 1
Nausea 11 11
Salivary Duct Inflammation 1 1
Vomiting 3 3
General Disorders and Administration Site Conditions Chills 1 1
Edema Limbs 2 2
Fatigue 22 7 29
Fever 3 3
Pain 3 1 4
Immune System Disorders Allergic Reaction 2 2
Infections and Infestations Lung Infection 1 1 2
Sinusitis 1 1
Skin Infection 1 2 3
Upper Respiratory Infection 4 4
Investigations Alanine Aminotransferase Increased 7 7
Aspartate Aminotransferase Increased 3 3
Lymphocyte Count Decreased 1 2 3
Neutrophil Count Decreased 2 23 15 1 41
Platelet Count Decreased 12 12
Weight Loss 2 2
White Blood Cell Decreased 13 6 19
Metabolism and Nutrition Disorders Anorexia 4 4
Bilirubin increased 1 1
Hyperglycemia 1 1
Hypocalcemia 1 1
Hypoglycemia 1 1
Hypophosphatemia 3 1 4
Musculoskeletal and Connective Tissue Disorders Arthralgia 3 1 4
Back Pain 1 1
Myalgia 2 1 3
Pain In Extremity 1 1 2
Skin nodules 1 1
Nervous System Disorders Dizziness 4 3 7
Dysgeusia 1 1
Facial Nerve Disorder 1 1
Headache 8 2 1 11
Neuralgia 1 1
Paresthesia 1 1 2
Peripheral Motor Neuropathy 2 2
Peripheral Sensory Neuropathy 1 1
Psychiatric Disorders Depression 1 1
Insomnia 1 1 2
Other (dysphoria) 1 1
Respiratory, Thoracic And Mediastinal Disorders Cough 3 3
Dyspnea 1 1
Nasal Congestion 6 6
Pharyngolaryngeal Pain 1 1
Sore Throat 1 1
Voice Alteration 1 1
Renal Acute kidney injury 1 1
Skin and Subcutaneous Tissue Disorders Dry Skin 3 1 4
Hyperhidrosis 1 1
Pruritus 8 2 10
Rash, Maculo-Papular 10 4 14
Other (Bleeding KS lesion, abnormal skin sensation) 2 2
Vascular Disorders Hypotension 1 1
Lymphedema 3 1 4
TOTAL (Occurrences) 215 84 23 2 324