Percentage of Participants Who Had a Hematopoietic Stem-Cell Transplant (HSCT)

Inotuzumab Ozogamicin

Participants were treated with inotuzumab ozogamicin at a starting dose of 1.8 mg/m\^2 (according to body surface area) per cycle with a divided-dose regimen using 3 weekly administrations. Participants received 0.8 mg/m\^2/cycle on Week 1 (Day 1), followed by 0.5 mg/m\^2 on Week 2 (Day 8) and Week 3 (Day 15) of a 21-day cycle, and administered as an intravenous infusion over 60 minutes. For participants who achieved a CR or CRi, or to allow recovery from toxicity, the length of Cycle 1 could be extended up to 28 days (ie, 1 week treatment-free interval starting on Day 21). For participants who achieved CR or CRi, the inotuzumab ozogamicin dose administered on Week 1 was reduced to 0.5 mg/m\^2 (for a total cycle dose of 1.5 mg/m\^2/cycle) for Cycles 2 through 6 (maximum number of cycles permitted). For Cycles 2 through 6, the cycle length was 28 days for all participants (regardless of remission status).

Defined Investigator's Choice of Chemotherapy

Participants received fludarabine, cytarabine, granulocyte-colony stimulating factor (FLAG), mitoxantrone + cytarabine (MXN/Ara-C), or high-dose cytarabine (HIDAC), according to the Investigator's choice.

Analysis denominator · Participants

1. ci Lower Limit

   22.6

   ci Num Sides

   TWO_SIDED

   ci Pct Value

   95

   ci Upper Limit

   40.6

   group Ids

   1. OG000
   2. OG001

   non Inferiority Type

   SUPERIORITY_OR_OTHER

   p Value

   <0.0001

   param Type

   Rate difference

   param Value

   31.6

   statistical Comment

   If any cell count was \<5, p-value was based on Fisher's exact test

   statistical Method

   1-sided p-value based on Chi-square test