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Table 2 Serious adverse events regardless of relationship to study drug

From: The use of erythropoiesis-stimulating agents with ruxolitinib in patients with myelofibrosis in COMFORT-II: an open-label, phase 3 study assessing efficacy and safety of ruxolitinib versus best available therapy in the treatment of myelofibrosis

 

Preferred term

Pt

Before ESA

After ESA

1

Cholesteatoma

 

2

Respiratory tract infection

General physical deteriorationa

Respiratory tract infectiona

Renal failure, acute

5

NA

Hip fracture

Septic shock

Pneumonitis

Depressed consciousness

6

Pulmonary arterial hypertension

Ascites

Anemiab

Encephalopathy

Varices esophageal

Enterococcal sepsis

Upper gastrointestinal hemorrhage

 

8

NA

Herpes zoster

Pulmonary embolism

Cardiac failure

9

NA

Abdominal pain

Urinary tract infection

Anemiaa,b

Radius fracture

Lung infiltration

Pneumonia

Sepsis

Renal failure

Supraventricular tachycardia

Hepatic failure

Tachypnea

Hyperuricemia

Lumbar vertebral fracture

Thoracic vertebral fracture

Respiratory failure

10

NA

Traumatic fracture

13

NA

Gastroenteritis

  1. ESA erythropoiesis-stimulating agent, NA not applicable (no SAE reported), pt patient, SAE serious adverse event
  2. aSuspected by the investigator to have a relationship to the study drug
  3. bCommon Toxicity Criteria Grade 3 anemia