. 2020 Jul 9;35(1):1–17. doi: 10.1038/s41375-020-0954-2

Table 2.

JAKARTA2 analysis populations [71].

ITT population (N = 97)	Stringent criteria cohort (n = 79)	Sensitivity analysis cohort (n = 66)
Ruxolitinib resistant or intolerant to ruxolitinib per investigator discretion: – Resistant: No response, stable disease, evidence of disease progression, or loss of response to ruxolitinib for ≥14 days – Intolerant: Discontinuation due to unacceptable toxicity after any duration of RUX exposure	Relapsed: Ruxolitinib treatment for ≥3 months with spleen regrowth, defined as <10% SVR or <30% decrease in spleen size from baseline, following an initial response. Response to ruxolitinib is defined as a ≥35% reduction in spleen volume from baseline, or a ≥50% reduction in spleen size for baseline spleen >10 cm; a non-palpable spleen for baseline spleen size between 5 and 10 cm; or not eligible for spleen response for baseline spleen <5 cm	Subgroup of patients within the Stringent Criteria Cohort who received 6 cycles of fedratinib therapy or discontinued before cycle 6 for reasons other than “study terminated by sponsor”
Refractory: Ruxolitinib treatment for ≥3 months with <10% SVR or <30% decrease in spleen size from baseline
Intolerant: Ruxolitinib treatment for ≥28 days complicated by development of RBC transfusion requirement (≥2 units per month for 2 months); or grade ≥ 3 thrombocytopenia, anemia, hematoma and/or hemorrhage while receiving ruxolitinib

ITT population (N = 97)

Stringent criteria cohort (n = 79)

Sensitivity analysis cohort (n = 66)

Ruxolitinib resistant or intolerant to ruxolitinib per investigator discretion:

– Resistant: No response, stable disease, evidence of disease progression, or loss of response to ruxolitinib for ≥14 days

– Intolerant: Discontinuation due to unacceptable toxicity after any duration of RUX exposure

Relapsed: Ruxolitinib treatment for ≥3 months with spleen regrowth, defined as <10% SVR or <30% decrease in spleen size from baseline, following an initial response. Response to ruxolitinib is defined as a ≥35% reduction in spleen volume from baseline, or a ≥50% reduction in spleen size for baseline spleen >10 cm; a non-palpable spleen for baseline spleen size between 5 and 10 cm; or not eligible for spleen response for baseline spleen <5 cm

Subgroup of patients within the Stringent Criteria Cohort who received 6 cycles of fedratinib therapy or discontinued before cycle 6 for reasons other than “study terminated by sponsor”

Refractory: Ruxolitinib treatment for ≥3 months with <10% SVR or <30% decrease in spleen size from baseline

Intolerant: Ruxolitinib treatment for ≥28 days complicated by development of RBC transfusion requirement (≥2 units per month for 2 months); or grade ≥ 3 thrombocytopenia, anemia, hematoma and/or hemorrhage while receiving ruxolitinib

RBC red blood cell, SVR spleen volume reduction.