Endocrine disorders: hirsutism

Eye disorders: blindness, ocular hypertension

Gastrointestinal disorders: gastrointestinal hemorrhage, glossodynia

General disorders and administration site conditions: malaise

Investigations: liver function tests abnormal, alanine aminotransferase increased

Nervous system disorders: cerebral ischemia

Psychiatric disorders: mood swings, hallucination, loss of libido

Reproductive system and breast disorders: erectile dysfunction

Respiratory, thoracic and mediastinal disorders: cough, hoarseness

Skin and subcutaneous tissue disorders: exanthem, skin hyperpigmentation

Myelodysplastic Syndromes:

A total of 148 patients received at least 1 dose of 10 mg REVLIMID in the del 5q MDS clinical study. At least one adverse event was reported in all of the 148 patients who were treated with the 10 mg starting dose of REVLIMID. The most frequently reported adverse events were related to blood and lymphatic system disorders, skin and subcutaneous tissue disorders, gastrointestinal disorders, and general disorders and administrative site conditions.

Thrombocytopenia (61.5%; 91/148) and neutropenia (58.8%; 87/148) were the most frequently reported adverse events. The next most common adverse events observed were diarrhea (48.6%; 72/148), pruritus (41.9%; 62/148), rash (35.8%; 53/148) and fatigue (31.1%; 46/148). Table 9 summarizes the adverse events that were reported in ≥ 5% of the REVLIMID treated patients in the del 5q MDS clinical study. Table 10 summarizes the most frequently observed Grade 3 and Grade 4 adverse reactions regardless of relationship to treatment with REVLIMID. In the single-arm studies conducted, it is often not possible to distinguish adverse events that are drug-related and those that reflect the patient’s underlying disease.

Table 9: Summary of Adverse Events Reported in ≥5% of the REVLIMID Treated Patients in del 5q MDS Clinical Study

[a] Body System and adverse events are coded using the MedDRA dictionary. Body System and adverse events are listed in descending order of frequency for the Overall column. A patient with multiple occurrences of an AE is counted only once in the AE category.

 10 mg Overall 
Body System  
Adverse Event [a] (N=148) 
Patients with at least one adverse event 148 (100.0) 
Blood and Lymphatic System Disorders
Thrombocytopenia
Neutropenia
Anemia
Leukopenia
Febrile Neutropenia 91 (61.5)
87 (58.8)
17 (11.5)
12 (8.1)
8 (5.4) 
Skin and Subcutaneous Tissue Disorders 
Pruritus
Rash
Dry Skin
Contusion
Night Sweats
Sweating Increased
Ecchymosis
Erythema 62 (41.9)
53 (35.8)
21 (14.2)
12 (8.1)
12 (8.1)
10 (6.8)
8 (5.4)
8 (5.4) 
Gastrointestinal Disorders 
Diarrhea
Constipation
Nausea
Abdominal Pain
Vomiting
Abdominal Pain Upper
Dry Mouth
Loose Stools 72 (48.6)
35 (23.6)
35 (23.6)
 18 (12.2)
15 (10.1)
12 (8.1)
10 (6.8)
9 (6.1) 
Respiratory, Thoracic and Mediastinal Disorders
Nasopharyngitis
Cough
Dyspnea
Pharyngitis
Epistaxis
Dyspnea Exertional
Rhinitis
Bronchitis 34 (23.0)
29 (19.6)
25 (16.9)
23 (15.5)
22 (14.9)
10 (6.8)
10 (6.8)
9 (6.1) 
General Disorders and Administr