‡
MRD (minimal residual disease) response was defined as MRD by PCR < 1 x 10‑4

§
n1: number of patients who achieved MRD response and the respective remission status; n2: number of patients who achieved the respective remission status. Six CR/CRh* responders with missing MRD data were considered as MRD-nonresponders.

¶
DOR (duration of response)/RFS (relapse-free survival) was defined as time since first response of CR or CRh* to relapse or death, whichever is earlier.
  N = 185
 
  CR*  CRh*†  CR/CRh*
  n (%)
  [95% CI]
 60 (32.4)
[25.7–39.7]
 17 (9.2)
[5.4–14.3]
 77 (41.6)
[34.4–49.1]
 
  MRD response‡ 
 
  n1/n2 (%)§
  [95% CI]
 48/60 (80.0)
[67.7–89.2]
 10/17 (58.8)
[32.9–81.6]
 58/77 (75.3)
[64.2–84.4]
 
  DOR/RFS¶ 
 
  Median (months) (range)
 6.7 (0.46–16.5)
 5.0 (0.13–8.8)
 5.9 (0.13–16.5)
 

16. HOW SUPPLIED/STORAGE AND HANDLING

16.1     How Supplied
Each BLINCYTO package (NDC 55513-160-01) contains:

•One BLINCYTO 35 mcg single-use vial containing a sterile, preservative-free, white to off-white lyophilized powder and
•One IV Solution Stabilizer 10 mL single-use glass vial containing a sterile, preservative-free, colorless to slightly yellow, clear solution. Do not use the IV Solution Stabilizer to reconstitute BLINCYTO.

16.2     Storage and Handling
Store BLINCYTO and IV Solution Stabilizer vials in the original package refrigerated at 2°C to 8°C (36°F to 46°F) and protect from light until time of use. Do not freeze. 

Store and transport the prepared IV bag containing BLINCYTO solution for infusion at 2°C to 8°C (36°F to 46°F) conditions. Ship in packaging that has been validated to maintain temperature of the contents at 2°C to 8°C (36°F to 46°F). Do not freeze.

17. PATIENT COUNSELING INFORMATION
See FDA-approved Medication Guide.

Advise patients to contact a healthcare professional for any of the following:

•Signs and symptoms that may be associated with cytokine release syndrome and infusion reactions including pyrexia, fatigue, nausea, vomiting, chills, hypotension, rash, and wheezing [see Warnings and Precautions (5.1) and Adverse Reactions (6.1)]
•Signs and symptoms of neurological toxicities including convulsions, speech disorders, and confusion [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)]
•Signs and symptoms of infections including pneumonia [see Warnings and Precautions (5.3) and Adverse Reactions (6.1)]
Advise patients to refrain from driving and engaging in hazardous occupations or activities such as operating heavy or potentially dangerous machinery while BLINCYTO is being administered. Patients should be advised that they may experience neurological events [see Warnings and Precautions (5.6)]. 

Inform patients that:

•It is very important to keep the area around the intravenous catheter clean to reduce the risk of infection.
•They should not adjust