Trial Outcomes & Findings for Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting (NCT NCT02484911)

NCT ID: NCT02484911

Last Updated: 2017-03-30

Results Overview

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 120 participants
• Primary outcome timeframe: 0 to 120 hours
• Results posted on: 2017-03-30

Participant Flow

Participant milestones

Measure	Olanzapine Regimen Olanzapine in combination with aprepitant ,palonosetron and dexamethasone. Olanzapine: 5mg,twice a day orally on day 1 to day 4 Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1 Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4	Control Regimen Aprepitant in combination with palonosetron and dexamethasone Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1 Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4
Overall Study STARTED	60	60
Overall Study COMPLETED	56	58
Overall Study NOT COMPLETED	4	2

Reasons for withdrawal

Measure	Olanzapine Regimen Olanzapine in combination with aprepitant ,palonosetron and dexamethasone. Olanzapine: 5mg,twice a day orally on day 1 to day 4 Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1 Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4	Control Regimen Aprepitant in combination with palonosetron and dexamethasone Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1 Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4
Overall Study Withdrawal by Subject	2	1
Overall Study Protocol Violation	2	1

Baseline Characteristics

Aprepitant ,Olanzapine,Palonosetron and Dexamethasone for the Prevention of Chemotherapy-induced Nausea and Vomiting

Baseline characteristics by cohort

Measure	Olanzapine Regimen n=56 Participants Olanzapine in combination with aprepitant ,palonosetron and dexamethasone. Olanzapine: 5mg,twice a day orally on day 1 to day 4 Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1 Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4	Control Regimen n=58 Participants Aprepitant in combination with palonosetron and dexamethasone Aprepitant: 125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3. Palonosetron: 0.25mg IV 30-60min before chemotherapy on day 1 Dexamethasone: 6mg IV on day 1 ，3.75mg IV on day 2 to 4	Total n=114 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	47 Participants n=93 Participants	49 Participants n=4 Participants	96 Participants n=27 Participants
Age, Categorical >=65 years	9 Participants n=93 Participants	9 Participants n=4 Participants	18 Participants n=27 Participants
Age, Continuous	55.43 years STANDARD_DEVIATION 9.55 • n=93 Participants	52.98 years STANDARD_DEVIATION 10.81 • n=4 Participants	54.18 years STANDARD_DEVIATION 10.24 • n=27 Participants
Sex: Female, Male Female	33 Participants n=93 Participants	37 Participants n=4 Participants	70 Participants n=27 Participants
Sex: Female, Male Male	23 Participants n=93 Participants	21 Participants n=4 Participants	44 Participants n=27 Participants
Region of Enrollment China	56 participants n=93 Participants	56 participants n=4 Participants	114 participants n=27 Participants
History of drinking YES	15 participants n=93 Participants	9 participants n=4 Participants	24 participants n=27 Participants
History of drinking NO	41 participants n=93 Participants	49 participants n=4 Participants	90 participants n=27 Participants

PRIMARY outcome

Timeframe: 0 to 120 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

Outcome measures

Measure	Olanzapine Regimen n=20 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=17 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving HEC With Complete Response in Overall Phase	20 Participants	15 Participants

PRIMARY outcome

Timeframe: 0 to 120 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

Outcome measures

Measure	Olanzapine Regimen n=36 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=41 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving MEC With Complete Response in Overall Phase	36 Participants	40 Participants

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.

Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

Outcome measures

Measure	Olanzapine Regimen n=20 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=17 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving HEC With Complete Response in the Acute Phase	20 Participants	17 Participants

SECONDARY outcome

Timeframe: 24 to 120 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.

Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

Outcome measures

Measure	Olanzapine Regimen n=20 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=17 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving HEC With Complete Response in the Delayed Phase	20 Participants	15 Participants

SECONDARY outcome

Timeframe: 0 to 120 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.

Overall phase was defined as 0 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Outcome measures

Measure	Olanzapine Regimen n=20 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=17 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving HEC With No Vomiting in the Overall Phase	17 Participants	6 Participants

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.

Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue ）

Outcome measures

Measure	Olanzapine Regimen n=20 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=17 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving HEC With No Vomiting in the Acute Phase	18 Participants	15 Participants

SECONDARY outcome

Timeframe: 24 to 120 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received High Emetogenic Chemotherapy (HEC), (2) took a dose of study drug, and (3) completed treatment.

Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Outcome measures

Measure	Olanzapine Regimen n=20 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=17 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving HEC With No Vomiting in the Delayed Phase	17 Participants	7 Participants

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.

Acute phase was defined as 0 to 24 hours following initiation of chemotherapy. Complete response was defined as no vomiting with no rescue therapy.

Outcome measures

Measure	Olanzapine Regimen n=36 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=41 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving MEC With Complete Response in the Acute Phase	36 Participants	41 Participants

SECONDARY outcome

Timeframe: 24 to 120 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.

Delayed phase was defined as 24 to 120 hours following initiation of chemotherapy.

Complete response was defined as no vomiting with no rescue therapy.

Outcome measures

Measure	Olanzapine Regimen n=36 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=41 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving MEC With Complete Response in the Delayed Phase	36 Participants	40 Participants

SECONDARY outcome

Timeframe: 0-120 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.

Overall Phase was defined as 0 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Outcome measures

Measure	Olanzapine Regimen n=36 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=41 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving MEC With No Vomiting in the Overall Phase	30 Participants	30 Participants

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.

Overall Phase was defined as 0 to 24 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Outcome measures

Measure	Olanzapine Regimen n=36 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=41 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving MEC With No Vomiting in the Acute Phase	35 Participants	40 Participants

SECONDARY outcome

Timeframe: 24 to 120 hours

Population: FAS (full analysis set) patient population was used for all efficacy evaluations and included patients who (1) received Moderate Emetogenic Chemotherapy (MEC), (2) took a dose of study drug, and (3) completed treatment.

Overall Phase was defined as 24 to 120 hours following initiation of chemotherapy.

No vomiting was defined as no vomiting or retching or dry heaves (included participants who received rescue therapy).

Outcome measures

Measure	Olanzapine Regimen n=36 Participants Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=41 Participants Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Proportion of Participants Receiving MEC With No Vomiting in the Delayed Phase	30 Participants	31 Participants

Adverse Events

Olanzapine Regimen

Serious events: 0 serious events

Other events: 21 other events

Deaths: 0 deaths

Control Regimen

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Olanzapine Regimen n=56 participants at risk Day 1:Olanzapine: 5mg twice po Aprepitant :125mg one hour po before chemotherapy Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day 2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV	Control Regimen n=58 participants at risk Day1： Aprepitant :125mg one hour before chemotherapy po, Palonosetron :0.25mg IV 30-60min before chemotherapy Dexamethasone: 6mg IV Day2-Day3: Olanzapine: 5mg twice Aprepitant:80mg po Dexamethasone: 3.75mg IV Day4: Olanzapine 5mg twice po Dexamethasone: 3.75mg IV
Gastrointestinal disorders Abdominal distension	3.6% 2/56 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received	3.4% 2/58 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received
Nervous system disorders Drowsiness	19.6% 11/56 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received	0.00% 0/58 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received
Nervous system disorders Dizzy	3.6% 2/56 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received	0.00% 0/58 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received
Nervous system disorders Headache	1.8% 1/56 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received	5.2% 3/58 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received
General disorders Fatigue	0.00% 0/56 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received	3.4% 2/58 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received
General disorders dry mouth	1.8% 1/56 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received	1.7% 1/58 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received
General disorders Oral ulcer	0.00% 0/56 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received	1.7% 1/58 • Day 1 up to Day 6, inclusive The Safety population consisted of all participants who received study drug. Participants are included in the treatment group based on the study drug they actually received

Additional Information

Dr.Zhang

First Affiliated Hospital of Harbin Medical University

Phone: 85555068

Email: daxinmay@126.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place