Trial Outcomes & Findings for Emend for Multiple-day Emetogenic Chemotherapy (NCT NCT00711555)

Results Overview

defined as a no emetic episodes and no use of rescue therapy

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

cycle 1, day 1

Results posted on

2021-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	Aprepitant, Dexamethasone, Ondansetron, Multiple Days
Overall Study STARTED	22
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Aprepitant, Dexamethasone, Ondansetron, Multiple Days
Overall Study Adverse Event	3

Baseline Characteristics

Emend for Multiple-day Emetogenic Chemotherapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Aprepitant, Dexamethasone, Ondansetron, Multiple Days n=22 Participants
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	21 Participants n=99 Participants
Age, Categorical >=65 years	1 Participants n=99 Participants
Age, Continuous	42 years STANDARD_DEVIATION 15 • n=99 Participants
Sex: Female, Male Female	10 Participants n=99 Participants
Sex: Female, Male Male	12 Participants n=99 Participants
Region of Enrollment United States	22 participants n=99 Participants

PRIMARY outcome

Timeframe: cycle 1, day 1

defined as a no emetic episodes and no use of rescue therapy

Outcome measures

Outcome measures
Measure	Aprepitant, Dexamethasone, Ondansetron, Multiple Days n=19 Participants
Complete Response (Percentage of Patients)	84 percentage of participants

SECONDARY outcome

Timeframe: cycle 1, day 1

defined as no emesis, no use of rescue medications, and a maximum nausea severity \< 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)

Outcome measures

Outcome measures
Measure	Aprepitant, Dexamethasone, Ondansetron, Multiple Days n=19 Participants
Complete Protection	74 percentage of participants

SECONDARY outcome

Timeframe: cycle 1, day 1

Outcome measures

Outcome measures
Measure	Aprepitant, Dexamethasone, Ondansetron, Multiple Days n=19 Participants
no Emesis	100 percentage of participants

SECONDARY outcome

Timeframe: cycle 1, day 1

defined as maximum nausea severity \< 5 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)

Outcome measures

Outcome measures
Measure	Aprepitant, Dexamethasone, Ondansetron, Multiple Days n=19 Participants
no Nausea	74 percentage of participants

SECONDARY outcome

Timeframe: cycle 1, day 1

defined as a maximum nausea severity \< 25 mm (100 mm visual analog scale, 0 = no nausea, 100 = worst nausea)

Outcome measures

Outcome measures
Measure	Aprepitant, Dexamethasone, Ondansetron, Multiple Days n=19 Participants
no Significant Nausea	79 percentage of participants

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sandra Cuellar

University of Illinois

Phone: 312-996-6985

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place