Trial Outcomes & Findings for Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED) (NCT NCT00952341)

NCT ID: NCT00952341

Last Updated: 2017-06-02

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: 421 participants
• Primary outcome timeframe: 0 to 120 hours
• Results posted on: 2017-06-02

Participant Flow

Participant milestones

Measure	Aprepitant (MK-0869) Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Cycle 1 STARTED	209	212
Cycle 1 COMPLETED	189	199
Cycle 1 NOT COMPLETED	20	13
Cycle 2 STARTED	110	130
Cycle 2 COMPLETED	101	118
Cycle 2 NOT COMPLETED	9	12

Reasons for withdrawal

Measure	Aprepitant (MK-0869) Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Cycle 1 Adverse Event	4	1
Cycle 1 Withdrawal by Subject	3	8
Cycle 1 Protocol Violation	2	1
Cycle 1 Lost to Follow-up	11	2
Cycle 1 Physician Decision	0	1
Cycle 2 Withdrawal by Subject	1	1
Cycle 2 Protocol Violation	1	0
Cycle 2 Lost to Follow-up	6	9
Cycle 2 Physician Decision	1	1
Cycle 2 Progressive Disease	0	1

Baseline Characteristics

Aprepitant/MK0869 for Prevention of Chemotherapy Induced Nausea and Vomiting Associated With Cisplatin (0869-169)(COMPLETED)

Baseline characteristics by cohort

Measure	Aprepitant (MK-0869) n=209 Participants Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo n=212 Participants Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin	Total n=421 Participants Total of all reporting groups
Age, Continuous	53.1 years STANDARD_DEVIATION 10.1 • n=5 Participants	53.6 years STANDARD_DEVIATION 10.6 • n=7 Participants	53.4 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	73 Participants n=7 Participants	144 Participants n=5 Participants
Sex: Female, Male Male	138 Participants n=5 Participants	139 Participants n=7 Participants	277 Participants n=5 Participants
Region of Enrollment China	209 participants n=5 Participants	212 participants n=7 Participants	421 participants n=5 Participants

PRIMARY outcome

Timeframe: 0 to 120 hours

Population: Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.

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	Aprepitant (MK-0869) n=204 Participants Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo n=207 Participants Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Proportion of Participants With Complete Response 120 Hours Following Initiation of High-dose Cisplatin Chemotherapy in the Overall Phase of Cycle 1	0.696 Proportion of participants	0.570 Proportion of participants

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.

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	Aprepitant (MK-0869) n=204 Participants Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo n=208 Participants Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Proportion of Participants With Complete Response in the Acute Phase of Cycle 1	0.794 Proportion of participants	0.793 Proportion of participants

SECONDARY outcome

Timeframe: 25 to 120 hours

Population: Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.

Delayed phase was defined as 25 to 120 hours following initiation of chemotherapy.

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

Outcome measures

Measure	Aprepitant (MK-0869) n=204 Participants Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo n=207 Participants Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Proportion of Participants With Complete Response in the Delayed Phase of Cycle 1	0.740 Proportion of participants	0.594 Proportion of participants

SECONDARY outcome

Timeframe: 0 to 120 hours

Population: Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.

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	Aprepitant (MK-0869) n=204 Participants Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo n=207 Participants Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Proportion of Participants With No Vomiting in the Overall Phase of Cycle 1	0.706 Proportion of participants	0.570 Proportion of participants

SECONDARY outcome

Timeframe: 0 to 24 hours

Population: Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.

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

Outcome measures

Measure	Aprepitant (MK-0869) n=204 Participants Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo n=208 Participants Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Proportion of Participants With No Vomiting in the Acute Phase of Cycle 1	0.804 Proportion of participants	0.798 Proportion of participants

SECONDARY outcome

Timeframe: 25 to 120 hours

Population: Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.

Delayed Phase was defined as 25 to 120 hours following initiation of chemotherapy

Outcome measures

Measure	Aprepitant (MK-0869) n=204 Participants Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo n=207 Participants Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Proportion of Participants With No Vomiting in the Delayed Phase of Cycle 1	0.740 Proportion of participants	0.594 Proportion of participants

SECONDARY outcome

Timeframe: 0 to 120 hours

Population: Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.

The Functional Living Index-Emesis is a self-administered, validated emesis & nausea-specific questionnaire. Participants completed the questionnaire 5 days post chemotherapy. It had 9 questions each on nausea and vomiting. "No impact of chemotherapy-induced nausea & vomiting (CINV) on daily life" was defined as an average item score of >6 on the 7-point scale (i.e., >108 total score). The scale was in the opposite direction for questions 3, 6, 11, 15 & 18. For each question: score ranged from 1 (worst) to 7 (best, i.e., no CINV). Total score range was 7 (worst) to 126 (best).

Outcome measures

Measure	Aprepitant (MK-0869) n=200 Participants Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo n=202 Participants Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Proportion of Participants With No Impact on Daily Life in Cycle 1	0.705 Proportion of participants	0.683 Proportion of participants

SECONDARY outcome

Timeframe: 0 to 120 hours

Population: Full Analysis Set (FAS), defined as those who received chemotherapy, received a dose of study drug and had at least one post-treatment assessment. Any participant who did not have a response recorded for the assessment was excluded from the analysis.

Time from administration of chemotherapy to first vomiting episode.

Outcome measures

Measure	Aprepitant (MK-0869) n=204 Participants Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: Intravenous (IV) granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo n=207 Participants Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Time to First Vomiting Episode in Cycle 1	77.0 Hours Standard Error 2.5	76.0 Hours Standard Error 2.8

Adverse Events

Aprepitant (MK-0869), Cycle 1 & Cycle 2

Serious events: 5 serious events

Other events: 123 other events

Deaths: 0 deaths

Placebo, Cycle 1 & Cycle 2

Serious events: 2 serious events

Other events: 124 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aprepitant (MK-0869), Cycle 1 & Cycle 2 n=205 participants at risk Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo, Cycle 1 & Cycle 2 n=210 participants at risk Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/205 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	0.48% 1/210 • Number of events 1 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
General disorders Death	0.49% 1/205 • Number of events 1 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	0.00% 0/210 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Infections and infestations Infection	0.00% 0/205 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	0.48% 1/210 • Number of events 1 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Infections and infestations Lung infection	0.49% 1/205 • Number of events 1 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	0.00% 0/210 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Investigations Neutrophil count decreased	0.49% 1/205 • Number of events 1 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	0.48% 1/210 • Number of events 1 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Investigations White blood cell count decreased	0.00% 0/205 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	0.48% 1/210 • Number of events 1 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.49% 1/205 • Number of events 1 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	0.00% 0/210 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Nervous system disorders Cerebral infarction	0.49% 1/205 • Number of events 1 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	0.00% 0/210 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.

Other adverse events

Measure	Aprepitant (MK-0869), Cycle 1 & Cycle 2 n=205 participants at risk Day 1: Oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Oral aprepitant 80 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin Day 1: oral dexamethasone 6 mg prior to the administration of cisplatin; Days 2 and 3: oral dexamethasone 3.75 mg	Placebo, Cycle 1 & Cycle 2 n=210 participants at risk Day 1: Placebo to oral aprepitant 125 mg prior to administration of cisplatin; Days 2 and 3: Placebo to oral aprepitant 80 mg Day 1: Oral dexamethasone 10.5 mg prior to administration of cisplatin; Days 2, 3, and 4: Oral dexamethasone 7.5 mg Day 1: IV granisetron 3 mg prior to administration of cisplatin
Gastrointestinal disorders Constipation	18.5% 38/205 • Number of events 41 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	14.8% 31/210 • Number of events 37 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Gastrointestinal disorders Diarrhoea	6.3% 13/205 • Number of events 13 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	3.8% 8/210 • Number of events 8 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Gastrointestinal disorders Nausea	5.9% 12/205 • Number of events 12 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	10.0% 21/210 • Number of events 22 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Gastrointestinal disorders Vomiting	3.4% 7/205 • Number of events 7 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	13.8% 29/210 • Number of events 31 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
General disorders Fatigue	6.3% 13/205 • Number of events 14 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	1.9% 4/210 • Number of events 4 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
General disorders Pyrexia	5.4% 11/205 • Number of events 13 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	2.4% 5/210 • Number of events 5 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Investigations Alanine aminotransferase increased	9.8% 20/205 • Number of events 22 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	10.0% 21/210 • Number of events 27 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Investigations Aspartate aminotransferase increased	3.4% 7/205 • Number of events 8 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	5.2% 11/210 • Number of events 12 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Investigations Haemoglobin decreased	7.3% 15/205 • Number of events 17 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	5.2% 11/210 • Number of events 16 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Investigations Neutrophil count decreased	16.1% 33/205 • Number of events 42 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	18.6% 39/210 • Number of events 48 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Investigations White blood cell count decreased	24.4% 50/205 • Number of events 65 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	23.3% 49/210 • Number of events 61 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Metabolism and nutrition disorders Decreased appetite	14.6% 30/205 • Number of events 33 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	13.8% 29/210 • Number of events 32 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.
Psychiatric disorders Insomnia	2.4% 5/205 • Number of events 5 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.	6.2% 13/210 • Number of events 13 The All Patients as Treated (APaT) population were used for the analysis of safety data in this study. The APaT population consisted of all randomized patients who received at least one dose of study medication.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.
• Publication restrictions are in place

Restriction type: OTHER