Trial Outcomes & Findings for An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP) (NCT NCT01129024)
NCT ID: NCT01129024
Last Updated: 2021-02-26
Results Overview
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product during the course of a clinical investigation, including any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product (IP), whether or not thought to be related to the IP. AEs reported after initial study drug administration were considered treatment-emergent. A serious adverse event is defined as any AE that resulted in death, was life-threatening, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect or an important medical event that, based upon medical judgment, may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. A treatment-related AE is any AE determined by the investigator to be possibly related, probably related, or definitely related to study drug.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
19 participants
Primary outcome timeframe
From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
Results posted on
2021-02-26
Participant Flow
Eligible participants who previously participated in Study 0913M0621 (NCT01054443) and who completed treatment or discontinued treatment due to a platelet count \> 400,000 cells/μL were rolled over into this open-label extension study.
Participant milestones
| Measure |
Lusutrombopag
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Overall Study
STARTED
|
19
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Lusutrombopag
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Overall Study
Physician Decision
|
5
|
|
Overall Study
Study Terminated by Sponsor
|
8
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lack of Efficacy
|
3
|
|
Overall Study
Needed a Platelet Transfusion
|
1
|
Baseline Characteristics
An Open-label Safety Study of Lusutrombopag (S-888711) in Adults With Chronic Immune Thrombocytopenia (ITP)
Baseline characteristics by cohort
| Measure |
Lusutrombopag
n=19 Participants
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Age, Continuous
|
54.7 years
STANDARD_DEVIATION 20.98 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.Population: All enrolled and treated participants
An AE is defined as any untoward medical occurrence in a subject administered a pharmaceutical product during the course of a clinical investigation, including any unfavorable and unintended sign, symptom, or disease temporally associated with the use of an investigational product (IP), whether or not thought to be related to the IP. AEs reported after initial study drug administration were considered treatment-emergent. A serious adverse event is defined as any AE that resulted in death, was life-threatening, hospitalization or prolongation of existing hospitalization, a persistent or significant disability/incapacity, or a congenital anomaly/birth defect or an important medical event that, based upon medical judgment, may jeopardize the participant or require medical or surgical intervention to prevent one of the outcomes listed above. A treatment-related AE is any AE determined by the investigator to be possibly related, probably related, or definitely related to study drug.
Outcome measures
| Measure |
Lusutrombopag
n=19 Participants
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Number of Participants With Adverse Events
Any treatment-emergent adverse event (TEAE)
|
19 Participants
|
|
Number of Participants With Adverse Events
Serious TEAEs
|
1 Participants
|
|
Number of Participants With Adverse Events
Treatment-related TEAEs
|
3 Participants
|
|
Number of Participants With Adverse Events
Treatment-related serious TEAEs
|
0 Participants
|
|
Number of Participants With Adverse Events
TEAEs leading to study discontinuation
|
2 Participants
|
SECONDARY outcome
Timeframe: From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on treatment was 148 (10 - 387) days.Population: All enrolled and treated participants
Duration of response was defined as the percentage of the cumulative time a platelet count was ≥ 50,000 cells/µL during the extension study.
Outcome measures
| Measure |
Lusutrombopag
n=19 Participants
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Duration of Response
|
0.200 percentage of days
Interval 0.0 to 0.8
|
SECONDARY outcome
Timeframe: Bleeding assessments were performed at Weeks 1, 2, 3, 4, 5, and 6, Months 1, 2, 3, 6, 9, and 12, and every 3 months thereafter until end of treatment; median (range) time on treatment was 148 (10-387) days.Population: All enrolled and treated participants
Bleeding assessments were performed by the Investigator according to the World Health Organization (WHO) criteria bleeding scale: Grade 0: no bleeding; Grade 1: petechial bleeding; Grade 2: mild blood loss (clinically significant); Grade 3: gross blood loss, requires transfusion (severe); Grade 4: debilitating blood loss, retinal or cerebral associated with fatality. For each participant, the most severe WHO bleeding grade observed during the treatment period is reported.
Outcome measures
| Measure |
Lusutrombopag
n=19 Participants
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period
Grade 0
|
3 Participants
|
|
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period
Grade 1
|
11 Participants
|
|
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period
Grade 2
|
5 Participants
|
|
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period
Grade 3
|
0 Participants
|
|
Number of Participants With Worst Severity of Bleeding Associated With ITP During the Treatment Period
Grade 4
|
0 Participants
|
SECONDARY outcome
Timeframe: Platelets were assessed at Weeks 1, 2, 3, 4, 5, and 6, Months 1, 2, 3, 6, 9, and 12, and every 3 months thereafter, until end of treatment; median (range) time on treatment was 148 (10-387) days.Population: All enrolled and treated participants
This analysis includes platelet counts measured during the treatment period, including while participants were taking rescue medications.
Outcome measures
| Measure |
Lusutrombopag
n=19 Participants
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Percentage of Participants Who Achieved a Platelet Count of < 50,000 Cells/μL, Between 50,000 to 400,000 Cells/μL, and ≥ 400,000 Cells/μL
Platelet count < 50,000 cells/μL
|
31.6 percentage of participants
|
|
Percentage of Participants Who Achieved a Platelet Count of < 50,000 Cells/μL, Between 50,000 to 400,000 Cells/μL, and ≥ 400,000 Cells/μL
Platelet count ≥ 50,000 and < 400 cells/μL
|
68.4 percentage of participants
|
|
Percentage of Participants Who Achieved a Platelet Count of < 50,000 Cells/μL, Between 50,000 to 400,000 Cells/μL, and ≥ 400,000 Cells/μL
Platelet count ≥ 400,000 cells/μL
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Platelets were assessed at Weeks 1, 2, 3, 4, 5, and 6, Months 1, 2, 3, 6, 9, and 12, and every 3 months thereafter, until end of treatment; median (range) time on treatment was 148 (10-387) days.Population: All enrolled and treated participants
This analysis excludes platelet counts measured while the participant was taking rescue medications and during the 4 weeks after rescue medication.
Outcome measures
| Measure |
Lusutrombopag
n=19 Participants
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Percentage of Participants Who Achieved a Platelet Count of < 50,000 Cells/μL, Between 50,000 to 400,000 Cells/μL, and ≥ 400,000 Cells/μL Without Rescue Medication
Platelet count < 50,000 cells/μL
|
42.1 percentage of participants
|
|
Percentage of Participants Who Achieved a Platelet Count of < 50,000 Cells/μL, Between 50,000 to 400,000 Cells/μL, and ≥ 400,000 Cells/μL Without Rescue Medication
Platelet count ≥ 50,000 and < 400,000 cells/μL
|
57.9 percentage of participants
|
|
Percentage of Participants Who Achieved a Platelet Count of < 50,000 Cells/μL, Between 50,000 to 400,000 Cells/μL, and ≥ 400,000 Cells/μL Without Rescue Medication
Platelet count ≥ 400,000 cells/μL
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and the final visit (If a subject had multiple platelet count measurements for the specific dose level due to dose adjustments, the final platelet count was used)Population: All enrolled and treated participants
Outcome measures
| Measure |
Lusutrombopag
n=19 Participants
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Change From Baseline in Platelet Counts at the Final Visit
Baseline
|
23000.00 cells/μL
Interval 9000.0 to 40000.0
|
|
Change From Baseline in Platelet Counts at the Final Visit
Final visit
|
23000.00 cells/μL
Interval 4000.0 to 124000.0
|
|
Change From Baseline in Platelet Counts at the Final Visit
Change from Baseline
|
3000.00 cells/μL
Interval -19000.0 to 108500.0
|
Adverse Events
Lusutrombopag
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lusutrombopag
n=19 participants at risk
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Injury, poisoning and procedural complications
Overdose
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Suicidal ideation
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
Other adverse events
| Measure |
Lusutrombopag
n=19 participants at risk
Participants received lusutrombopag 0.5 mg administered orally once a day for up to 3 years or until study termination. The dose was adjusted based on platelet counts.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
42.1%
8/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Upper respiratory tract infection
|
15.8%
3/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Urinary tract infection
|
10.5%
2/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Fungal infection
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Pharyngitis
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Burn infection
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Ear infection
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Folliculitis
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Influenza
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Sinusitis
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Staphylococcal infection
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Infections and infestations
Tonsillitis
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
26.3%
5/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.8%
3/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
10.5%
2/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal blistering
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Nausea
|
15.8%
3/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Vomiting
|
15.8%
3/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
10.5%
2/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Dental caries
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Gingival bleeding
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Gingival pain
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Gastrointestinal disorders
Salivary gland disorder
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
26.3%
5/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.5%
2/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.5%
2/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
10.5%
2/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
General disorders
Fatigue
|
31.6%
6/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
General disorders
Oedema peripheral
|
10.5%
2/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
General disorders
Cyst
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
General disorders
Pain
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
15.8%
3/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Skin and subcutaneous tissue disorders
Blood blister
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Injury, poisoning and procedural complications
Contusion
|
15.8%
3/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Injury, poisoning and procedural complications
Mouth injury
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Blood and lymphatic system disorders
Idiopathic thrombocytopenic purpura
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Blood and lymphatic system disorders
Bone marrow reticulin fibrosis
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Insomnia
|
10.5%
2/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Affective disorder
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Alcoholism
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Bipolar disorder
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Depression
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Middle insomnia
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Personality disorder
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Polysubstance dependence
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Psychiatric disorders
Tachyphrenia
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Investigations
Blood potassium decreased
|
10.5%
2/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Investigations
C-reactive protein increased
|
10.5%
2/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Investigations
Platelet count decreased
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Investigations
Transaminases increased
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Eye disorders
Myodesopsia
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Eye disorders
Eye pruritus
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Eye disorders
Vision blurred
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Eye disorders
Visual impairment
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Reproductive system and breast disorders
Breast fibrosis
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Reproductive system and breast disorders
Breast pain
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Reproductive system and breast disorders
Breast tenderness
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Nervous system disorders
Balance disorder
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Nervous system disorders
Carotid artery disease
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Nervous system disorders
Migraine
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Nervous system disorders
Somnolence
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Vascular disorders
Haematoma
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Vascular disorders
Hot flush
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Vascular disorders
Phlebitis superficial
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Ear and labyrinth disorders
Ear pain
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Ear and labyrinth disorders
Ear discomfort
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Renal and urinary disorders
Dysuria
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Renal and urinary disorders
Pollakiuria
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
|
Cardiac disorders
Atrial fibrillation
|
5.3%
1/19 • From first dose of study drug in the extension study up to 6 weeks after last dose; median (range) time on study treatment was 148 (10-387) days.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can embargo results from a PI's center until the combined results from the completed study have been published in full or the sponsor confirms there will be no multicenter study publication. Results communications must be provided to the sponsor for review at least 60 days before submission for publication. By written request, the sponsor can extend the embargo up to an additional 60 days. The sponsor cannot require changes to scientific content and cannot further extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER