Skip to main content

Table 4 Treatment-emergent adverse events resulting in death*

From: Long-term treatment with ruxolitinib for patients with myelofibrosis: 5-year update from the randomized, double-blind, placebo-controlled, phase 3 COMFORT-I trial

Cause of death, n (%)a

Ruxolitinib randomized (n = 155)

After ruxolitinib crossoverb (n = 111)

During placebo treatment (n = 151)

Death caused by any treatment-emergent adverse event

28 (18.1)

28 (25.2)

11 (7.3)

Sepsis

4 (2.6)

2 (1.8)

1 (0.7)

Disease progression

3 (1.9)

4 (3.6)

3 (2.0)

Pneumonia

3 (1.9)

1 (0.9)

1 (0.7)

Acute myeloid leukemia

2 (1.3)

3 (2.7)

0

Cerebral hemorrhage

2 (1.3)

1 (0.9)

1 (0.7)

Septic shock

2 (1.3)

2 (1.8)

0

Acute renal failure

1 (0.6)

1 (0.9)

0

Anemia

1 (0.6)

0

0

Cardiac arrest

1 (0.6)

0

0

Death, unspecified

1 (0.6)

1 (0.9)

0

Falling injury

1 (0.6)

0

0

Hemorrhagic shock

1 (0.6)

1 (0.9)

0

Metastatic NSCLC

1 (0.6)

0

0

Multiorgan failure

1 (0.6)

0

1 (0.7)

Muscular weakness

1 (0.6)

0

0

Myocardial infarction

1 (0.6)

1 (0.9)

0

Pancreatic carcinoma

1 (0.6)

0

0

Renal failure

1 (0.6)

0

0

Respiratory failure

1 (0.6)

0

0

Splenic infarction

1 (0.6)

0

0

Congestive cardiac failure

0

2 (1.8)

0

Myelofibrosis

0

2 (1.8)

1 (0.7)

Cardiac failure

0

1 (0.9)

0

Pneumonia aspiration

0

2 (1.8)

0

Anastomotic hemorrhage

0

1 (0.9)

0

Cholecystitis

0

1 (0.9)

0

Delirium

0

1 (0.9)

0

Road traffic accident

0

1 (0.9)

0

Splenic rupture

0

1 (0.9)

0

Suicide

0

1 (0.9)

0

Gastrointestinal hemorrhage

0

0

1 (0.7)

Intestinal perforation

0

0

1 (0.7)

Staphylococcal infection

0

0

1 (0.7)

  1. NSCLC, non-small cell lung cancer
  2. *Limited to fatal treatment-emergent adverse events occurring during treatment with study drug or within 28 days of the last dose of study drug
  3. aPatient deaths were counted once under each Medical Dictionary for Regulatory Activities system organ class and preferred term, and therefore individual patients may have had >1 cause of death
  4. bFatal treatment-emergent adverse events that occurred following the first dose of ruxolitinib (ie, after crossover from placebo) were included in the ruxolitinib crossover group