Trial Outcomes & Findings for Efficacy of Pioglitazone in Participants With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy (NCT NCT01972724)
NCT ID: NCT01972724
Last Updated: 2018-09-12
Results Overview
The change from baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 24. A negative change from baseline indicates improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
114 participants
Primary outcome timeframe
Baseline and Week 24
Results posted on
2018-09-12
Participant Flow
Participants took part in the study at 15 investigative sites in Korea from 16 December 2013 to 17 October 2016.
Participants with a diagnosis of Type 2 Diabetes Mellitus were enrolled equally in one of 2 treatment groups in the Double-Blind study: pioglitazone15 mg + metformin + sulfonylurea or pioglitazone pioglitazone 30 mg plus metformin + sulfonylurea. Participants received pioglitazone 30 mg + metformin + sulfonylurea in the Open Label study.
Participant milestones
| Measure |
Pioglitazone 15 mg (Double-Blind)
Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Double-Blind)
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Open-Label)
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
|---|---|---|---|
|
Double-Blind
STARTED
|
19
|
18
|
0
|
|
Double-Blind
Intent-to-treat:Received Study Drug
|
17
|
17
|
0
|
|
Double-Blind
COMPLETED
|
10
|
9
|
0
|
|
Double-Blind
NOT COMPLETED
|
9
|
9
|
0
|
|
Open-Label
STARTED
|
0
|
0
|
77
|
|
Open-Label
COMPLETED
|
0
|
0
|
72
|
|
Open-Label
NOT COMPLETED
|
0
|
0
|
5
|
Reasons for withdrawal
| Measure |
Pioglitazone 15 mg (Double-Blind)
Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Double-Blind)
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Open-Label)
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
|---|---|---|---|
|
Double-Blind
Rescue Criteria Met
|
1
|
0
|
0
|
|
Double-Blind
Adverse Event
|
1
|
0
|
0
|
|
Double-Blind
Withdrawal of Consent
|
2
|
1
|
0
|
|
Double-Blind
Significant Protocol Deviation
|
5
|
8
|
0
|
|
Open-Label
Withdrew Consent
|
0
|
0
|
3
|
|
Open-Label
Significant Protocol Deviation
|
0
|
0
|
2
|
Baseline Characteristics
Efficacy of Pioglitazone in Participants With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy
Baseline characteristics by cohort
| Measure |
Pioglitazone 15 mg (Double-Blind)
n=17 Participants
Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Double-Blind)
n=17 Participants
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Open-Label)
n=77 Participants
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Total
n=111 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
59.6 years
FULL_RANGE 8.73 • n=5 Participants
|
57.0 years
FULL_RANGE 12.0 • n=7 Participants
|
59.2 years
FULL_RANGE 7.88 • n=5 Participants
|
58.6 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Region of Enrollment
Korea, Republic Of
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
111 Participants
n=4 Participants
|
|
Height
|
161.94 cm
FULL_RANGE 8.392 • n=5 Participants
|
163.50 cm
FULL_RANGE 9.702 • n=7 Participants
|
163.25 cm
FULL_RANGE 9.148 • n=5 Participants
|
162.89 cm
n=4 Participants
|
|
Weight
|
70.39 kg
n=5 Participants
|
71.20 kg
n=7 Participants
|
70.38 kg
n=5 Participants
|
70.65 kg
n=4 Participants
|
|
Body Mass Index (BMI)
|
26.86 kg/m^2
n=5 Participants
|
26.46 kg/m^2
n=7 Participants
|
26.25 kg/m^2
n=5 Participants
|
26.52 kg/m^2
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population was defined as all participants who took at least 1 dose of the study drug. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure.
The change from baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 24. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Pioglitazone 15 mg (Double-Blind)
n=17 Participants
Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Double-Blind)
n=17 Participants
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Open-Label)
n=76 Participants
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
|
-0.0003 percentage of glycosylated hemoglobin
Standard Deviation 0.00725
|
-0.0030 percentage of glycosylated hemoglobin
Standard Deviation 0.00894
|
-0.0275 percentage of glycosylated hemoglobin
Standard Deviation 0.21126
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: Intent-to-treat population was defined as all participants who took at least 1 dose of the study drug.
The change between the value of fasting serum glucose collected at Week 24 and fasting serum glucose collected at baseline. A negative change from baseline indicates improvement.
Outcome measures
| Measure |
Pioglitazone 15 mg (Double-Blind)
n=17 Participants
Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Double-Blind)
n=17 Participants
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Open-Label)
n=77 Participants
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
|---|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose at Week 24
|
0.6727 mmol/L
Standard Deviation 1.80662
|
-0.4278 mmol/L
Standard Deviation 1.88067
|
-0.4412 mmol/L
Standard Deviation 2.30378
|
Adverse Events
Pioglitazone 15 mg (Double-Blind)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Pioglitazone 30 mg (Double-Blind)
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Pioglitazone 30 mg (Open-Label)
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pioglitazone 15 mg (Double-Blind)
n=17 participants at risk
Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Double-Blind)
n=17 participants at risk
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Open-Label)
n=77 participants at risk
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
1.3%
1/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
1.3%
1/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
1.3%
1/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
1.3%
1/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
1.3%
1/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
Other adverse events
| Measure |
Pioglitazone 15 mg (Double-Blind)
n=17 participants at risk
Pioglitazone 15 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Double-Blind)
n=17 participants at risk
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
Pioglitazone 30 mg (Open-Label)
n=77 participants at risk
Pioglitazone 30 mg tablets, orally, once daily, and metformin and sulfonylurea administered according to the prescribing information of the approved Korean label, for up to 24 weeks.
|
|---|---|---|---|
|
Eye disorders
Conjunctival haemorrhage
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Eye disorders
Eyelid oedema
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Gastrointestinal disorders
Vomiting
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
General disorders
Oedema
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
11.8%
2/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Infections and infestations
Nasopharyngitis
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Injury, poisoning and procedural complications
Ligament injury
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Injury, poisoning and procedural complications
Venom poisoning
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Nervous system disorders
Post herpetic neuralgia
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
5.9%
1/17 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
0.00%
0/77 • First dose of study drug up to 30 days after the last dose of study drug (Up to Week 28)
At each visit investigator had to document any occurrence of adverse events (AEs) and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. For other AEs a result of 0 in the table means there are no participants at a threshold of \>=5%.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER