Percentage of Patients With Complete Response (CR) Defined as no Emesis, no Rescue Medication at Cycle 1

Netupitant and Palonosetron Plus Dexamethasone

Oral netupitant/palonosetron (300 mg/0.50 mg) hard capsule with oral dexamethasone, both given on Day 1, prior to each scheduled chemotherapy cycle Netupitant and Palonosetron Dexamethasone

Palonosetron Plus Dexamethasone

Oral palonosetron 0.50 mg (Aloxi) with oral dexamethasone both given on Day 1, prior to each scheduled chemotherapy cycle Palonosetron Dexamethasone

Analysis denominator · Participants

1. ci Lower Limit

   1.0

   ci Num Sides

   TWO_SIDED

   ci Pct Value

   95

   ci Upper Limit

   1.87

   group Description

   CR in the acute phase was to be tested using the same 2 sided CMH test as for the primary endpoint. netupitant/palonosetron combination was to be considered superior to palonosetron in the acute phase if the 2 sided p value from the CMH was less than or equal to 0.050 and in the right direction.

   group Ids

   1. OG000
   2. OG001

   non Inferiority Type

   SUPERIORITY_OR_OTHER

   p Value

   0.047

   p Value Comment

   If the null hypothesis for CR delayed was rejected, analysis of the first key secondary endpoint CR acute was to be performed. Since the analysis was performed according to a hierarchical procedure, no further adjustment for multiplicity was needed.

   param Type

   Odds Ratio (OR)

   param Value

   1.37

   statistical Comment

   Cochran Mantel Haenszel (CMH) test including treatment, age class and region as strata. All missing data were to be imputed as treatment failures.

   statistical Method

   Cochran-Mantel-Haenszel

   tested Non Inferiority

   false