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Multicenter study of romiplostim for CIT
Table 2. Venous thromboembolic events in cohort while on romiplostim treatment for chemotherapy-induced thrombocytopenia (CIT) and within 30 days of romiplostim discontinuation.
Patient information
46 y M, Astrocytoma
61 y M, Pancreatic Ca Stage IIB
49 y F, Cervical Ca Stage IV
58 y M, Pancreatic Ca Stage III
67 y M, Pancreatic Ca Stage IV
67 y M, Cholangiocarcinoma Stage IV
53 y M, Cholangiocarcinoma Stage IV
59 y M, Pancreatic Ca Stage IV
Type of VTE
Proximal lower extremity DVT
Peripherally inserted
central venous catheter-associated
upper extremity DVT
Renal vein thrombosis
Segmental PE, splenic infarct
Proximal lower extremity DVT
Central venous
catheter-associated
internal jugular vein thrombus
Bilateral distal lower extremity DVT
Segmental PE
Platelet count at VTE
150×109/L
119×109/L
147×109/L 146×109/L 156×109/L 65×109/L
307×109/L
118×109/L
Notes
Plt: platelet count; Ca: cancer;VTE: venous thromboembolism; y: years; M: male; F: female; DVT: deep venous thrombosis; PE: pulmonary embolus.
Table 3. Bleeding events in cohort while on romiplostim treatment for chemotherapy-induced thrombocytopenia (CIT).
Occurred in setting of hospitalization, following T4 compression fracture, bilateral thoracic decompression surgery; thrombocytosis with platelet count in 500-600x109/L range present the week prior
Patient information
84 y M, DLBCL Stage IV
61 y M, Pancreatic
Ca Stage IIB
63 y F, SCLC Stage IV
59 y M, GIST Stage IV
85 y M, Pancreatic Ca Stage IIB
74 y M, NSCLC Stage IV
40 y F, Endometrial Ca Stage IVa
40 y F, Endometrial Ca
Stage IVa
60 y F, Lung Ca
Stage IV
72 y F, Endometrial Ca
Type of bleed
Subdural hematoma
Upper
GI bleed
Hemorrhagic brain metastases
Upper GI bleed
Oral mucosa
bleeding
Upper GI
bleed
Lower GI bleed
Lower GI
bleed
Cutaneous ecchymoses Vaginal bleeding GI bleed Upper GI bleed Epistaxis
GI bleed
Platelet count at bleed
198×109/L
142×109/L
55×109/L
115×109L
19×109/L
80×109/L
49×109/L
49×109/L
11×109/L
10×109/L
170×109/L
82×109/L
79×109/L 239×109/L
On WHO anticoagulation grade
at bleed?
No 4
No 4
No 4
Yes 4
(fondaparinux)
Yes (rivaroxaban) 1
Yes (aspirin) 3
No 3
No 3
No 2
No 3
No 3
No 2
Yes (rivaroxaban) 3 No 3
CTCAE Red cell v.4.03 transfusion grade requirements
2 None
4 9 units
pRBC 1 None
4 6 units pRBC
1 None
3 3 units pRBC
3 4 units pRBC
3 9 units pRBC
2 None
3 2 units pRBC
3 2 units pRBC
2 None
3 1 unit pRBC 3 3 units pRBC
Notes
Occurred after a fall and strike to the head
Bleeding from
duodenal ulcer
Asymptomatic, incidentally discovered
In setting of radiation proctitis
In setting
of radiation
proctitis
Stage IV
61 y M, Colorectal Ca Stage IV 58 y M, Pancreatic Ca Stage III
66 y M, Cholangiocarcinoma Stage IV
39 y M, Colorectal Ca Stage IV
Ca: cancer; CTCAE: Common Terminology Criteria for Adverse Events; DLBCL: diffuse large B-cell lymphoma; GI: gastrointestinal; NSCLC: non-small cell lung cancer; Plt: platelet count; pRBC: packed red blood cells; SCLC: small cell lung cancer; WHO: World Health Organization. aSame patient, two separate bleeding events (separated by 2 months) that each occurred at the same platelet count.
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