Trial Outcomes & Findings for Postmarketing Clinical Study on AO-128 (NCT NCT02287402)
NCT ID: NCT02287402
Last Updated: 2015-04-09
Results Overview
Frequency tabulations of the "assessment of diabetic status in the treatment period (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in the "Full Analysis Set".
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
197 participants
Primary outcome timeframe
Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.
Results posted on
2015-04-09
Participant Flow
Participants took part in the study at 30 investigative sites in Japan from 9 March 2010 to 15 November 2012.
Participants with impaired glucose tolerance (IGT) who had been non-responsive to diet therapy and exercise therapy receive one AO-128 0.2 mg tablet orally 3 times a day before meals.
Participant milestones
| Measure |
AO-128 0.6 mg
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Treatment Period
STARTED
|
197
|
|
Treatment Period
COMPLETED
|
170
|
|
Treatment Period
NOT COMPLETED
|
27
|
|
Follow-up
STARTED
|
106
|
|
Follow-up
COMPLETED
|
103
|
|
Follow-up
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
AO-128 0.6 mg
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Treatment Period
Adverse Event
|
17
|
|
Treatment Period
Voluntary Withdrawal
|
10
|
|
Follow-up
Lost to Follow-up
|
1
|
|
Follow-up
Voluntary Withdrawal
|
2
|
Baseline Characteristics
Postmarketing Clinical Study on AO-128
Baseline characteristics by cohort
| Measure |
AO-128 0.6 mg
n=197 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Age, Continuous
|
59.2 years
STANDARD_DEVIATION 9.35 • n=39 Participants
|
|
Age, Customized
<65 years
|
137 participants
n=39 Participants
|
|
Age, Customized
≥65 years
|
60 participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=39 Participants
|
|
Region of Enrollment
Japan
|
197 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Treatment period: Up to 122 weeks. Treatment was to be ended when patients were assessed as Type 2 Diabetes Mellitus or normoglycemic.Population: Full Analysis Set - All participants who received at least 1 dose of open-label study drug.
Frequency tabulations of the "assessment of diabetic status in the treatment period (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in the "Full Analysis Set".
Outcome measures
| Measure |
AO-128 0.6 mg
n=197 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)
Type 2 Diabetes mellitus
|
25 participants
|
|
Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)
Normoglycemia
|
106 participants
|
|
Assessment of Diabetic Status in the Treatment Period (Type 2 Diabetes Mellitus, Normoglycemia, or Impaired Glucose Tolerance (IGT)
IGT
|
66 participants
|
PRIMARY outcome
Timeframe: Follow-up at Week 12, 24, 36, and 48Population: Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.
Frequency tabulations of the "assessment of diabetic status in the follow-up (Type 2 Diabetes mellitus, normoglycemia, or IGT)" were prepared in patients who proceeded to the follow-up in the "Full Analysis Set".
Outcome measures
| Measure |
AO-128 0.6 mg
n=106 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)
Type 2 Diabetes mellitus
|
3 participants
|
|
Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)
Normoglycemia
|
9 participants
|
|
Assessment of Diabetic Status in Follow-up (Type 2 Diabetes Mellitus, Normoglycemia, or IGT)
IGT
|
94 participants
|
SECONDARY outcome
Timeframe: Day 168, 336, 504, and 672Population: Full Analysis Set - All participants who received at least 1 dose of open-label study drug.
The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the "time to progression to Type 2 Diabetes mellitus in the treatment period" in the "Full Analysis Set".
Outcome measures
| Measure |
AO-128 0.6 mg
n=197 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method
Day 168
|
0.0 percentage of participants
|
|
Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method
Day 336
|
4.4 percentage of participants
|
|
Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method
Day 504
|
10.2 percentage of participants
|
|
Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated by the Kaplan-Meier Method
Day 672
|
16.9 percentage of participants
|
SECONDARY outcome
Timeframe: Day 168, 336, 504, and 672Population: Full Analysis Set - All participants who received at least 1 dose of open-label study drug.
The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the "time to progression to type 2 diabetes mellitus in the treatment period" in the "Full Analysis Set".
Outcome measures
| Measure |
AO-128 0.6 mg
n=197 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function
Day 168
|
0.0 percentage of participants
|
|
Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function
Day 336
|
3.3 percentage of participants
|
|
Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function
Day 504
|
6.9 percentage of participants
|
|
Time to Progression to Type 2 Diabetes Mellitus in the Treatment Period Calculated Using the Cumulative Incidence Function
Day 672
|
10.0 percentage of participants
|
SECONDARY outcome
Timeframe: Day 168, 336, 504, and 672Population: Full Analysis Set - All participants who received at least 1 dose of open-label study drug.
The cumulative progression rate (percentage of participants) was calculated by the Kaplan-Meier method for the "time to improvement to normoglycemia in the treatment period" in the "Full Analysis Set".
Outcome measures
| Measure |
AO-128 0.6 mg
n=197 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method
Day 168
|
18.9 percentage of participants
|
|
Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method
Day 336
|
37.5 percentage of participants
|
|
Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method
Day 504
|
50.2 percentage of participants
|
|
Time to Improvement to Normoglycemia in the Treatment Period Calculated by the Kaplan-Meier Method
Day 672
|
60.3 percentage of participants
|
SECONDARY outcome
Timeframe: Day 168, 336, 504, and 672Population: Full Analysis Set - All participants who received at least 1 dose of open-label study drug.
The cumulative progression rate (percentage of participants) was calculated using the cumulative incidence function for the "time to improvement to normoglycemia in the treatment period" in the "Full Analysis Set".
Outcome measures
| Measure |
AO-128 0.6 mg
n=197 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function
Day 168
|
18.9 percentage of participants
|
|
Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function
Day 336
|
36.9 percentage of participants
|
|
Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function
Day 504
|
48.4 percentage of participants
|
|
Time to Improvement to Normoglycemia in the Treatment Period Measured Values by the Cumulative Incidence Function
Day 672
|
57.1 percentage of participants
|
SECONDARY outcome
Timeframe: Week 0, 24, 48, 72, 96, 120, and the end of the treatment periodPopulation: Full Analysis Set - All participants who received at least 1 dose of open-label study drug.
Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in the "Full Analysis Set."
Outcome measures
| Measure |
AO-128 0.6 mg
n=197 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)
Week 0
|
166.7 mg/dL
Standard Deviation 17.34
|
|
2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)
Week 24
|
148.0 mg/dL
Standard Deviation 34.30
|
|
2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)
Week 48
|
153.2 mg/dL
Standard Deviation 36.58
|
|
2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)
Week 72
|
155.6 mg/dL
Standard Deviation 36.77
|
|
2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)
Week 96
|
155.6 mg/dL
Standard Deviation 33.17
|
|
2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)
Week 120
|
163.2 mg/dL
Standard Deviation 31.89
|
|
2-Hour Plasma Glucose During 75 g Oral Glucose Tolerance Test (OGTT)
The end of the treatment period
|
142.8 mg/dL
Standard Deviation 37.73
|
SECONDARY outcome
Timeframe: Follow-up at week 0, 12, 24, 36, and 48Population: Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.
Summary statistics were calculated at each assessment time point for the 2-hour plasma glucose during 75 g OGTT in participants who proceeded to the follow-up in the "Full Analysis Set."
Outcome measures
| Measure |
AO-128 0.6 mg
n=106 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
2-Hour Plasma Glucose During 75 g OGTT at Follow-up
Follow-up at Week 0
|
119.4 mg/dL
Standard Deviation 15.82
|
|
2-Hour Plasma Glucose During 75 g OGTT at Follow-up
Follow-up at Week 12
|
148.3 mg/dL
Standard Deviation 35.26
|
|
2-Hour Plasma Glucose During 75 g OGTT at Follow-up
Follow-up at Week 24
|
147.9 mg/dL
Standard Deviation 29.69
|
|
2-Hour Plasma Glucose During 75 g OGTT at Follow-up
Follow-up at Week 36
|
145.9 mg/dL
Standard Deviation 18.94
|
|
2-Hour Plasma Glucose During 75 g OGTT at Follow-up
Follow-up at Week 48
|
138.3 mg/dL
Standard Deviation 20.06
|
SECONDARY outcome
Timeframe: Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment period.Population: Full Analysis Set - All participants who received at least 1 dose of open-label study drug.
Summary statistics were calculated at each assessment time point for the HbA1c in the "Full Analysis Set."
Outcome measures
| Measure |
AO-128 0.6 mg
n=197 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Hemoglobin A1c (HbA1c)
Week 0
|
5.45 percent
Standard Deviation 0.331
|
|
Hemoglobin A1c (HbA1c)
Week 12
|
5.35 percent
Standard Deviation 0.305
|
|
Hemoglobin A1c (HbA1c)
Week 24
|
5.30 percent
Standard Deviation 0.302
|
|
Hemoglobin A1c (HbA1c)
Week 48
|
5.37 percent
Standard Deviation 0.317
|
|
Hemoglobin A1c (HbA1c)
Week 72
|
5.34 percent
Standard Deviation 0.285
|
|
Hemoglobin A1c (HbA1c)
Week 96
|
5.41 percent
Standard Deviation 0.269
|
|
Hemoglobin A1c (HbA1c)
Week 120
|
5.45 percent
Standard Deviation 0.256
|
|
Hemoglobin A1c (HbA1c)
The end of the treatment period
|
5.35 percent
Standard Deviation 0.323
|
SECONDARY outcome
Timeframe: Follow-up at Week 0, 12, 24, 36, and 48Population: Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.
Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the "Full Analysis Set."
Outcome measures
| Measure |
AO-128 0.6 mg
n=106 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
HbA1c at Follow-up
Follow-up at Week 12
|
5.27 percent
Standard Deviation 0.330
|
|
HbA1c at Follow-up
Follow-up at Week 24
|
5.26 percent
Standard Deviation 0.326
|
|
HbA1c at Follow-up
Follow-up at Week 0
|
5.23 percent
Standard Deviation 0.292
|
|
HbA1c at Follow-up
Follow-up at Week 36
|
5.20 percent
Standard Deviation 0.301
|
|
HbA1c at Follow-up
Follow-up at Week 48
|
5.28 percent
Standard Deviation 0.260
|
SECONDARY outcome
Timeframe: Week 0, 12, 24, 48, 72, 96, 120, and the end of the treatment periodPopulation: Full Analysis Set - All participants who received at least 1 dose of open-label study drug.
Summary statistics were calculated at each assessment time point for the body weight in the "Full Analysis Set."
Outcome measures
| Measure |
AO-128 0.6 mg
n=197 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Body Weight
Week 0
|
70.74 kg
Standard Deviation 13.708
|
|
Body Weight
Week 12
|
69.74 kg
Standard Deviation 13.659
|
|
Body Weight
Week 24
|
69.91 kg
Standard Deviation 13.658
|
|
Body Weight
Week 48
|
69.25 kg
Standard Deviation 13.632
|
|
Body Weight
Week 72
|
70.03 kg
Standard Deviation 13.955
|
|
Body Weight
Week 96
|
69.25 kg
Standard Deviation 14.484
|
|
Body Weight
Week 120
|
68.82 kg
Standard Deviation 14.835
|
|
Body Weight
The end of the treatment period
|
68.96 kg
Standard Deviation 13.892
|
SECONDARY outcome
Timeframe: Follow-up at Week 0, 12, 24, 36, and 48Population: Participants from the Full Analysis Set, all participants who received at least 1 dose of open-label study drug, and continued to Follow-up.
Summary statistics were calculated at each assessment time point for the HbA1c in patients who proceeded to the follow-up in the "Full Analysis Set."
Outcome measures
| Measure |
AO-128 0.6 mg
n=106 Participants
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Body Weight at Follow-up
Follow-up at Week 0
|
67.60 kg
Standard Deviation 13.023
|
|
Body Weight at Follow-up
Follow-up at Week 12
|
67.76 kg
Standard Deviation 13.035
|
|
Body Weight at Follow-up
Follow-up at Week 24
|
68.87 kg
Standard Deviation 11.703
|
|
Body Weight at Follow-up
Follow-up at Week 36
|
70.13 kg
Standard Deviation 11.754
|
|
Body Weight at Follow-up
Follow-up at Week 48
|
68.72 kg
Standard Deviation 13.844
|
Adverse Events
AO-128 0.6 mg
Serious events: 15 serious events
Other events: 165 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AO-128 0.6 mg
n=197 participants at risk
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Infections and infestations
Pneumonia
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Sinusitis
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Herpes zoster oticus
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer stage 0
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Nystagmus
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Eye disorders
Cataract
|
1.0%
2/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Cardiac disorders
Cardiac failure
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.0%
2/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal septum deviation
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Calculus urinary
|
1.0%
2/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Calculus ureteric
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.51%
1/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Other adverse events
| Measure |
AO-128 0.6 mg
n=197 participants at risk
One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
|
|---|---|
|
Infections and infestations
Nasopharyngitis
|
26.4%
52/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Influenza
|
4.1%
8/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Pharyngitis
|
3.6%
7/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Bronchitis
|
3.0%
6/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Infections and infestations
Gastroenteritis
|
3.0%
6/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Immune system disorders
Seasonal allergy
|
3.6%
7/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Nervous system disorders
Headache
|
3.6%
7/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
7.1%
14/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.7%
29/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Flatulence
|
14.2%
28/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Abdominal distension
|
13.2%
26/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Gastrointestinal disorders
Constipation
|
5.1%
10/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.0%
6/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Investigations
Alanine aminotransferase increased
|
3.0%
6/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.6%
7/197 • From the first dose of open-label study drug until the day of the last dose of open-label study drug.
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
|
Additional Information
Hitoshi Onouchi
Japan Development Center, Pharmaceutical Development Division, Takeda Pharmaceutical Company Limited
Phone: +81-6-6204-5116
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The clinical trial contract states that information should never be disclosed without prior consent of the sponsor, although it does not specify the number of days during which disclosure of information is limited.
- Publication restrictions are in place
Restriction type: OTHER