Trial Outcomes & Findings for Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003) (NCT NCT04254978)
NCT ID: NCT04254978
Last Updated: 2024-04-02
Results Overview
An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during the study, in conjunction with the use of the drug or biologic, whether or not product related. This includes any untoward signs or symptoms experienced by the participant from the time of first dose with study treatment until completion of the study. The number of participants who experienced an AE is reported.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
73 participants
Primary outcome timeframe
Up to approximately 30 months
Results posted on
2024-04-02
Participant Flow
Participant milestones
| Measure |
Bomedemstat
Bomedemstat was administered daily for 169 consecutive days of the initial treatment period. After completing 169 days of treatment, qualifying participants continued into additional treatment periods of 169 days each, for as long as the participant continued to derive clinical benefit.
|
|---|---|
|
Initial Treatment Period (ITP)
STARTED
|
73
|
|
Initial Treatment Period (ITP)
COMPLETED
|
64
|
|
Initial Treatment Period (ITP)
NOT COMPLETED
|
9
|
|
Additional Treatment Period (ATP)
STARTED
|
63
|
|
Additional Treatment Period (ATP)
COMPLETED
|
52
|
|
Additional Treatment Period (ATP)
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Bomedemstat
Bomedemstat was administered daily for 169 consecutive days of the initial treatment period. After completing 169 days of treatment, qualifying participants continued into additional treatment periods of 169 days each, for as long as the participant continued to derive clinical benefit.
|
|---|---|
|
Initial Treatment Period (ITP)
Withdrawal by Subject
|
3
|
|
Initial Treatment Period (ITP)
Adverse Event
|
5
|
|
Initial Treatment Period (ITP)
Lack of Efficacy
|
1
|
|
Additional Treatment Period (ATP)
Withdrawal by Subject
|
3
|
|
Additional Treatment Period (ATP)
Physician Decision
|
1
|
|
Additional Treatment Period (ATP)
Adverse Event
|
7
|
Baseline Characteristics
Study of Bomedemstat in Participants With Essential Thrombocythemia (IMG-7289-CTP-201/MK-3543-003)
Baseline characteristics by cohort
| Measure |
Bomedemstat
n=73 Participants
Bomedemstat administered daily for 169 consecutive days
|
|---|---|
|
Age, Continuous
|
64.8 Years
STANDARD_DEVIATION 10.40 • n=5 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
71 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown or not reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Aboriginal
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 30 monthsPopulation: All participants who were enrolled in the study and received at least 1 dose of study drug
An AE is any undesirable physical, psychological or behavioral effect experienced by a participant during the study, in conjunction with the use of the drug or biologic, whether or not product related. This includes any untoward signs or symptoms experienced by the participant from the time of first dose with study treatment until completion of the study. The number of participants who experienced an AE is reported.
Outcome measures
| Measure |
Bomedemstat
n=73 Participants
Bomedemstat was administered daily for 169 consecutive days of the initial treatment period. After completing 169 days of treatment, qualifying patients continued into additional treatment periods of 169 days each, as long as the participant continued to derive clinical benefit.
|
|---|---|
|
Number of Participants Who Experienced an Adverse Event (AE)
|
73 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 28 monthsPopulation: All participants who were enrolled in the study and received at least one dose of study drug
An AE is any undesirable physical, psychological or behavioral effect experienced by a patient during participation in the study, in conjunction with the use of the drug or biologic, whether or not product-related. This includes any untoward signs or symptoms experienced by the patient from the time of first dose with study treatment until completion of the study. The number of participants who discontinued study treatment due to an AE is reported.
Outcome measures
| Measure |
Bomedemstat
n=73 Participants
Bomedemstat was administered daily for 169 consecutive days of the initial treatment period. After completing 169 days of treatment, qualifying patients continued into additional treatment periods of 169 days each, as long as the participant continued to derive clinical benefit.
|
|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an AE
|
11 Participants
|
PRIMARY outcome
Timeframe: Up to day 169Population: All participants who were enrolled in the study, received at least one dose of study drug, and had a non-missing baseline and at least 1 non-missing post-baseline efficacy assessment.
Blood samples were collected at pre-specified timepoints to determine platelet counts. The percentage of participants who achieved reduction in platelet count to ≤400k/μL in the absence of new thrombolytic events is reported.
Outcome measures
| Measure |
Bomedemstat
n=64 Participants
Bomedemstat was administered daily for 169 consecutive days of the initial treatment period. After completing 169 days of treatment, qualifying patients continued into additional treatment periods of 169 days each, as long as the participant continued to derive clinical benefit.
|
|---|---|
|
Percentage of Participants With Platelet Count ≤400 k/μL at Day 169
|
76.6 Percentage of Participants
Interval 64.3 to 86.2
|
Adverse Events
Bomedemstat
Serious events: 27 serious events
Other events: 72 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Bomedemstat
n=73 participants at risk
Bomedemstat was administered daily for 169 consecutive days of the initial treatment period. After completing 169 days of treatment, qualifying patients continued into additional treatment periods of 169 days each, as long as the participant continued to derive clinical benefit.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Chronic gastritis
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
2.7%
2/73 • Number of events 2 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Ileal ulcer
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Inguinal hernia
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
2.7%
2/73 • Number of events 2 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
4.1%
3/73 • Number of events 3 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia aspiration
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
2.7%
2/73 • Number of events 2 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
2/73 • Number of events 3 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Haematoma muscle
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Synovitis
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
1.4%
1/73 • Number of events 2 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Nervous system disorders
Transient ischaemic attack
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea paroxysmal nocturnal
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Surgical and medical procedures
Rotator cuff repair
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Vascular disorders
Vasculitis
|
1.4%
1/73 • Number of events 1 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
Other adverse events
| Measure |
Bomedemstat
n=73 participants at risk
Bomedemstat was administered daily for 169 consecutive days of the initial treatment period. After completing 169 days of treatment, qualifying patients continued into additional treatment periods of 169 days each, as long as the participant continued to derive clinical benefit.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
19.2%
14/73 • Number of events 35 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
11.0%
8/73 • Number of events 12 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
31.5%
23/73 • Number of events 47 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
8.2%
6/73 • Number of events 7 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
39.7%
29/73 • Number of events 35 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
20.5%
15/73 • Number of events 22 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
8.2%
6/73 • Number of events 6 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
8.2%
6/73 • Number of events 6 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Large intestine polyp
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
13.7%
10/73 • Number of events 17 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
5/73 • Number of events 5 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
General disorders
Fatigue
|
28.8%
21/73 • Number of events 35 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
12.3%
9/73 • Number of events 10 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
15.1%
11/73 • Number of events 15 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
26.0%
19/73 • Number of events 19 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
5.5%
4/73 • Number of events 5 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
6.8%
5/73 • Number of events 5 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
5.5%
4/73 • Number of events 6 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
6.8%
5/73 • Number of events 9 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
24.7%
18/73 • Number of events 25 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Limb injury
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
5.5%
4/73 • Number of events 8 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
9.6%
7/73 • Number of events 8 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
8.2%
6/73 • Number of events 8 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Gout
|
5.5%
4/73 • Number of events 5 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
9.6%
7/73 • Number of events 7 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
39.7%
29/73 • Number of events 75 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
16.4%
12/73 • Number of events 13 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
6.8%
5/73 • Number of events 9 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
8.2%
6/73 • Number of events 6 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.8%
5/73 • Number of events 6 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.2%
6/73 • Number of events 6 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.2%
6/73 • Number of events 6 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.3%
9/73 • Number of events 18 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
15.1%
11/73 • Number of events 12 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
58.9%
43/73 • Number of events 62 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
16.4%
12/73 • Number of events 26 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
6.8%
5/73 • Number of events 10 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
8.2%
6/73 • Number of events 8 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
9.6%
7/73 • Number of events 8 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
19.2%
14/73 • Number of events 17 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.5%
4/73 • Number of events 5 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
5.5%
4/73 • Number of events 5 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.2%
14/73 • Number of events 17 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
5.5%
4/73 • Number of events 4 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
5.5%
4/73 • Number of events 6 • Up to approximately 30 months
The all cause mortality population includes all participants enrolled and randomized in the study. The serious adverse event (AE) and other AE population includes all participants who were enrolled in the study and received at least one dose of study drug.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Lead/Coordinating Investigator will have the right to submit for publication any results arising from the study subject to the terms and conditions of the Clinical Trial and Confidentiality Disclosure Agreements.
- Publication restrictions are in place
Restriction type: OTHER