Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Study PMA112509, a Phase I/II Study of Eltrombopag in Thrombocytopenic Subjects With Advanced Myelodysplastic Syndrome (MDS) or Secondary Acute Myeloid Leukemia After MDS (sAML/MDS)
Brief Summary: This study will evaluate the safety and tolerability of eltrombopag in the treatment of low platelet counts in adult subjects with advanced myelodysplastic syndrome (MDS), secondary acute myeloid leukemia after MDS (sAML/MDS), or de novo AML that are relapsed, refractory or ineligible to receive azacitidine, decitabine, intensive chemotherapy or autologous/allogeneic stem cell transplantation. This is a placebo-controlled study in which patients will receive study medication daily for 6 months, during which time the dose of study medication may be adjusted based upon individual platelet counts and bone marrow blast counts. All subjects will receive best standard of care (platelet transfusions, mild chemotherapy, cytokines, valproic acid, all-trans retinoic acid, ESAs or G-CSF) in addition to study medication. Subjects taking placebo may be allowed to crossover to eltrombopag treatment if a clinically and statistically significant improvement in bone marrow blast counts is seen in subjects treated with eltrombopag.


Options:
A: Arm Label: Eltrombopag; Type: ACTIVE_COMPARATOR; Interventions: Drug: eltrombopag olamine | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Other: Placebo | Intervention Type: DRUG; Name: eltrombopag olamine; Assigned to Arm(s): Eltrombopag | Intervention Type: OTHER; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: FXIII17.5IU/Kg; Type: EXPERIMENTAL; Interventions: Drug: catridecacog | Arm Label: FXIII35IU/Kg; Type: EXPERIMENTAL; Interventions: Drug: catridecacog | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: placebo | Intervention Type: DRUG; Name: catridecacog; Assigned to Arm(s): FXIII17.5IU/Kg | Intervention Type: DRUG; Name: catridecacog; Assigned to Arm(s): FXIII35IU/Kg | Intervention Type: DRUG; Name: placebo; Assigned to Arm(s): Placebo
C: Arm Label: 750 mcg AMG 531; Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 | Arm Label: Placebo Part B; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Placebo Part A; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: 500 mcg AMG 531; Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 | Arm Label: 750 mcg AMG531 Part B; Type: ACTIVE_COMPARATOR; Interventions: Biological: AMG 531 | Intervention Type: BIOLOGICAL; Name: AMG 531; Assigned to Arm(s): 500 mcg AMG 531, 750 mcg AMG 531, 750 mcg AMG531 Part B | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo Part A, Placebo Part B
D: Arm Label: WAS patients receiving Promacta; Type: EXPERIMENTAL; Interventions: Drug: Promacta | Arm Label: WAS patients for blood drawing only; Type: EXPERIMENTAL; Interventions: Diagnostic Test: blood drawing in patients with WAS | Arm Label: healthy children for blood drawing only; Type: PLACEBO_COMPARATOR; Interventions: Diagnostic Test: blood drawing in healthy controls | Intervention Type: DRUG; Name: Promacta; Assigned to Arm(s): WAS patients receiving Promacta | Intervention Type: DIAGNOSTIC_TEST; Name: blood drawing in patients with WAS; Assigned to Arm(s): WAS patients for blood drawing only | Intervention Type: DIAGNOSTIC_TEST; Name: blood drawing in healthy controls; Assigned to Arm(s): healthy children for blood drawing only

Answer: A