Trial Outcomes & Findings for Open Label Extension Study of AMG 531 in Japanese Subjects With ITP (NCT NCT00440037)
NCT ID: NCT00440037
Last Updated: 2020-01-21
Results Overview
Subjects who reported at least 1 adverse event after beginning treatment with romiplostim in this study
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
44 participants
Primary outcome timeframe
Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)
Results posted on
2020-01-21
Participant Flow
Subjects who had completed any previous romiplostim ITP study in Japan (Studies 20050162/NCT00305435 or 20060216/NCT00603642) were eligible to screen for this study. The study began in October 2006 and continued until romiplostim was commercially available in Japan.
Participant milestones
| Measure |
AMG 531
AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
|
|---|---|
|
Overall Study
STARTED
|
44
|
|
Overall Study
COMPLETED
|
35
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
AMG 531
AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Administrative decision
|
3
|
Baseline Characteristics
Open Label Extension Study of AMG 531 in Japanese Subjects With ITP
Baseline characteristics by cohort
| Measure |
AMG 531
n=44 Participants
AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
|
|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 12.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)Population: Subjects in Safety Analysis Set
Subjects who reported at least 1 adverse event after beginning treatment with romiplostim in this study
Outcome measures
| Measure |
AMG 531
n=44 Participants
AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
|
|---|---|
|
Percentage of Participants With Adverse Events Including Clinically Significant Changes in Laboratory Values.
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)Population: Subjects with at least 1 immunoassay available
Subjects with positive anti-AMG 531 antibodies (either to the peptide portion of AMG 531 or to the intact molecule) and antibodies that cross-react with endogenous thrombopoietin (TPO)
Outcome measures
| Measure |
AMG 531
n=44 Participants
AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
|
|---|---|
|
Incidence of Anti AMG 531 Antibody Formation
Positive for romiplostim-neutralizing antibodies
|
0 percentage of participants
|
|
Incidence of Anti AMG 531 Antibody Formation
Positive for TPO-neutralizing antibodies
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)Outcome measures
| Measure |
AMG 531
n=44 Participants
AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
|
|---|---|
|
Incidence of Platelet Response (Platelet Response is Defined as a Doubling of Baseline Platelet Counts and More Than 50 x 10^9/L; Baseline Platelet Counts is That Obtained in the Previous Study)
|
95.5 percentage of participants
Interval 84.5 to 99.4
|
SECONDARY outcome
Timeframe: Through study completion, the median treatment duration (time between first dose and last dose) was 146.0 weeks (range: 12 to 243 weeks)Population: Subjects who were receiving concurrent ITP therapy at baseline
Outcome measures
| Measure |
AMG 531
n=25 Participants
AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
|
|---|---|
|
Percentage of Subjects Able to Reduce or Discontinue Their Concurrent ITP Therapies (for Subjects That Are Receiving Oral Corticosteroids at a Constant Dose and Schedule at the Screening Visit)
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: By Week 48Short Form 36 (SF-36): The SF-36 has 36 questions with 8 domains: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. In addition to deriving a score for each of the domains, the SF-36 generates 2 summary scores: a physical component summary (PCS) and a mental component summary (MCS). These 8 domains and 2 summary scores are scored from 0 to 100, with higher scores indicating better health status. The official version in Japanese was used in this study. Euroqol-5 Dimensions (EQ-5D): The EQ-5D is a patient-completed, multidimensional measure of HRQOL. EQ-5D index values range from -0.59 to 1.00. The EQ-5D visual analogue scale (VAS) records the respondents' self-rated health status on a vertical graduated (0 to 100) visual analogue scale. Higher EQ-5D Index and VAS scores represent better health status. The official version in Japanese was used in this study.
Outcome measures
| Measure |
AMG 531
n=44 Participants
AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
|
|---|---|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in EQ-5D Index score at Week 48
|
0.02 score on a scale
Standard Deviation 0.12
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in EQ-5D VAS score at Week 48
|
6.13 score on a scale
Standard Deviation 16.48
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in SF-36 physical functioning at Week 48
|
0.68 score on a scale
Standard Deviation 7.19
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in SF-36 role physical at Week 48
|
2.30 score on a scale
Standard Deviation 10.43
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in SF-36 bodily pain at Week 48
|
-0.87 score on a scale
Standard Deviation 13.42
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in SF-36 General Health Perception at W48
|
1.30 score on a scale
Standard Deviation 5.14
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in SF-36 Vitality at Week 48
|
1.12 score on a scale
Standard Deviation 8.42
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in SF-36 Social Functioning at Week 48
|
1.22 score on a scale
Standard Deviation 8.56
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in SF-36 Role Emotional at Week 48
|
1.84 score on a scale
Standard Deviation 12.82
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in SF-36 Mental Health at Week 48
|
-1.42 score on a scale
Standard Deviation 9.04
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in SF-36 Physical Component at Week 48
|
1.13 score on a scale
Standard Deviation 6.85
|
|
Change From Baseline in Patient-reported Outcome (PRO) Endpoints at Each Time Point (Baseline PRO is Obtained at Day 1 Predose)
Change in SF-36 Mental Component at Week 48
|
0.33 score on a scale
Standard Deviation 9.19
|
Adverse Events
AMG 531
Serious events: 12 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AMG 531
n=44 participants at risk
AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
|
|---|---|
|
Blood and lymphatic system disorders
Haemorrhagic Anaemia
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Cardiac disorders
Arrhythmia
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Colonic polyp
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Melaena
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Mouth Haemorrhage
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
General disorders
Feeling Abnormal
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
General disorders
Pyrexia
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Hepatobiliary disorders
Cholelithiasis
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Infections and infestations
Appendicitis
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Allergic Transfusion Reaction
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Pneumothorax Traumatic
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Subcutaneous Haematoma
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Wound
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Musculoskeletal and connective tissue disorders
Lumbar Spinal Stenosis
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Nervous system disorders
Grand Mal Convulsion
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Nervous system disorders
Intracranial Aneurysm
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Nervous system disorders
Transient Ischaemic Attack
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Vascular disorders
Deep Vein Thrombosis
|
2.3%
1/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
Other adverse events
| Measure |
AMG 531
n=44 participants at risk
AMG531 was administered by SC injection once per week from Week 1 (Day 1). The maximum permitted dose of AMG531 was 10 μg/kg.
|
|---|---|
|
Blood and lymphatic system disorders
Iron Deficiency Anaemia
|
11.4%
5/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Ear and labyrinth disorders
Vertigo
|
18.2%
8/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Eye disorders
Conjunctival Haemorrhage
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Eye disorders
Conjunctivitis
|
9.1%
4/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
18.2%
8/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Colonic Polyp
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Constipation
|
11.4%
5/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Dental Caries
|
13.6%
6/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
15.9%
7/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Gastritis
|
9.1%
4/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Gingivitis
|
9.1%
4/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Haemorrhoids
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Nausea
|
9.1%
4/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Stomatitis
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Toothache
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Gastrointestinal disorders
Vomiting
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
General disorders
Malaise
|
18.2%
8/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
General disorders
Oedema Peripheral
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
General disorders
Pyrexia
|
9.1%
4/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
9.1%
4/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Infections and infestations
Bronchitis
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Infections and infestations
Cystitis
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Infections and infestations
Gastroenteritis
|
11.4%
5/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Infections and infestations
Nasopharyngitis
|
79.5%
35/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Infections and infestations
Pharyngitis
|
11.4%
5/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
9.1%
4/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
20.5%
9/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Excoriation
|
13.6%
6/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Laceration
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
9.1%
4/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Injury, poisoning and procedural complications
Wound
|
11.4%
5/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.2%
8/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
27.3%
12/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
13.6%
6/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
9.1%
4/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
18.2%
8/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Nervous system disorders
Headache
|
43.2%
19/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Nervous system disorders
Hypoaesthesia
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Psychiatric disorders
Depression
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Psychiatric disorders
Insomnia
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.4%
5/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Inflammation
|
15.9%
7/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
15.9%
7/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Skin and subcutaneous tissue disorders
Haemorrhage Subcutaneous
|
9.1%
4/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
11.4%
5/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.4%
5/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
6.8%
3/44 • The duration of treatment in this study ranged from 12 to 243 weeks; the median (Q1, Q3) duration of treatment in this study was 146.0 (119.5, 166.0) weeks.
|
Additional Information
Research & Development Planning Department , Research & Development Division
Kyowa Kirin Co., Ltd.
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place