Trial Outcomes & Findings for Study to Assess the Safety and Efficacy of PT010, PT003, and PT009 in Japanese Subjects With COPD Compared With Symbicort® Turbohaler® (NCT NCT03262012)

NCT ID: NCT03262012

Last Updated: 2020-05-13

Results Overview

Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

416 participants

Primary outcome timeframe

28 Weeks

Results posted on

2020-05-13

Participant Flow

This study was conducted at 75 study centers in Japan, from Aug 2016 to June 2018. This is an extension study of PT010006 and could take up to an additional 28 weeks.

Subjects were randomized in a 2:2:1:1 scheme.

Participant milestones

Participant milestones
Measure	BGF MDI 320/14.4/9.6 ug Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug	BFF MDI 320/9.6 ug Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug	Symbicort TBH 400/12 ug BID Open Label Symbicort Turbuhaler 400/12 ug BID
Overall Study STARTED	139	138	70	69
Overall Study COMPLETED	112	102	56	54
Overall Study NOT COMPLETED	27	36	14	15

Reasons for withdrawal

Reasons for withdrawal
Measure	BGF MDI 320/14.4/9.6 ug Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug	BFF MDI 320/9.6 ug Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug	Symbicort TBH 400/12 ug BID Open Label Symbicort Turbuhaler 400/12 ug BID
Overall Study Withdrawal by Subject	15	13	8	7
Overall Study Adverse Event	10	12	4	6
Overall Study Physician Decision	2	5	1	0
Overall Study Lack of Efficacy	0	5	1	2
Overall Study Protocol Discontinuation Criteria	0	1	0	0

Baseline Characteristics

Japanese Safety Population

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BGF MDI 320/14.4/9.6 ug n=139 Participants Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug n=138 Participants Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug	BFF MDI 320/9.6 ug n=70 Participants Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug	Symbicort TBH 400/12 ug BID n=69 Participants Open Label Symbicort Turbuhaler 400/12 ug BID	Total n=416 Participants Total of all reporting groups
Age, Continuous	69.4 Years STANDARD_DEVIATION 7.1 • n=5 Participants • Japanese Safety Population	69.0 Years STANDARD_DEVIATION 6.1 • n=7 Participants • Japanese Safety Population	69.7 Years STANDARD_DEVIATION 6.1 • n=5 Participants • Japanese Safety Population	70.1 Years STANDARD_DEVIATION 6.8 • n=4 Participants • Japanese Safety Population	69.5 Years STANDARD_DEVIATION 6.5 • n=21 Participants • Japanese Safety Population
Sex: Female, Male Female	9 Participants n=5 Participants • Japanese Safety Population	12 Participants n=7 Participants • Japanese Safety Population	2 Participants n=5 Participants • Japanese Safety Population	1 Participants n=4 Participants • Japanese Safety Population	24 Participants n=21 Participants • Japanese Safety Population
Sex: Female, Male Male	130 Participants n=5 Participants • Japanese Safety Population	126 Participants n=7 Participants • Japanese Safety Population	68 Participants n=5 Participants • Japanese Safety Population	68 Participants n=4 Participants • Japanese Safety Population	392 Participants n=21 Participants • Japanese Safety Population
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=7 Participants • Japanese subjects randomized	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=4 Participants • Japanese subjects randomized	0 Participants n=21 Participants • Japanese subjects randomized
Ethnicity (NIH/OMB) Not Hispanic or Latino	139 Participants n=5 Participants • Japanese subjects randomized	138 Participants n=7 Participants • Japanese subjects randomized	69 Participants n=5 Participants • Japanese subjects randomized	69 Participants n=4 Participants • Japanese subjects randomized	415 Participants n=21 Participants • Japanese subjects randomized
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=7 Participants • Japanese subjects randomized	1 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=4 Participants • Japanese subjects randomized	1 Participants n=21 Participants • Japanese subjects randomized
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=7 Participants • Japanese subjects randomized	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=4 Participants • Japanese subjects randomized	0 Participants n=21 Participants • Japanese subjects randomized
Race (NIH/OMB) Asian	139 Participants n=5 Participants • Japanese subjects randomized	138 Participants n=7 Participants • Japanese subjects randomized	70 Participants n=5 Participants • Japanese subjects randomized	69 Participants n=4 Participants • Japanese subjects randomized	416 Participants n=21 Participants • Japanese subjects randomized
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=7 Participants • Japanese subjects randomized	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=4 Participants • Japanese subjects randomized	0 Participants n=21 Participants • Japanese subjects randomized
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=7 Participants • Japanese subjects randomized	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=4 Participants • Japanese subjects randomized	0 Participants n=21 Participants • Japanese subjects randomized
Race (NIH/OMB) White	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=7 Participants • Japanese subjects randomized	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=4 Participants • Japanese subjects randomized	0 Participants n=21 Participants • Japanese subjects randomized
Race (NIH/OMB) More than one race	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=7 Participants • Japanese subjects randomized	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=4 Participants • Japanese subjects randomized	0 Participants n=21 Participants • Japanese subjects randomized
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=7 Participants • Japanese subjects randomized	0 Participants n=5 Participants • Japanese subjects randomized	0 Participants n=4 Participants • Japanese subjects randomized	0 Participants n=21 Participants • Japanese subjects randomized

PRIMARY outcome

Timeframe: 28 Weeks

Population: Japanese Safety Population

Number of participants post-baseline newly occurring or worsening PCS (potentially clinically significant) clinical chemistry values

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 ug n=137 Participants Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug n=137 Participants Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug	BFF MDI 320/9.6 ug n=68 Participants Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug	Symbicort TBH 400/12 ug n=68 Participants Open Label Symbicort Turbuhaler 400/12 ug BID
Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values ALT >3 x ULN	0 Count of Participants	1 Count of Participants	0 Count of Participants	0 Count of Participants
Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values Total Bilirubin >2 x ULN	0 Count of Participants	0 Count of Participants	0 Count of Participants	1 Count of Participants
Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values Potassium (mmol/L) >6.0	2 Count of Participants	0 Count of Participants	0 Count of Participants	0 Count of Participants
Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values Glucose (mmol/L) >13.9 if Baseline is ≤10.0	0 Count of Participants	1 Count of Participants	1 Count of Participants	1 Count of Participants
Incidence of Post-baseline Newly Occurring or Worsening PCS (Potentially Clinically Significant) Clinical Chemistry Values Glucose (mmol/L) >16.7 if baseline is >10.0	0 Count of Participants	1 Count of Participants	0 Count of Participants	0 Count of Participants

PRIMARY outcome

Timeframe: 28 Weeks

Population: Japanese Safety Population

Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 ug n=139 Participants Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug n=138 Participants Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug	BFF MDI 320/9.6 ug n=70 Participants Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug	Symbicort TBH 400/12 ug n=69 Participants Open Label Symbicort Turbuhaler 400/12 ug BID
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs Systolic Blood Pressure >=180, Incr >=20	3 Particpants	1 Particpants	0 Particpants	0 Particpants
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs Systolic Blood Pressure, <=90, Decr >=20	4 Particpants	1 Particpants	1 Particpants	1 Particpants
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs Diastolic Blood Pressure, >=105 Incr, >=15	2 Particpants	1 Particpants	2 Particpants	0 Particpants
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs Diastolic Blood Pressure, <=50, Decr >=15	4 Particpants	3 Particpants	2 Particpants	3 Particpants
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs Tachycardia Event >=110, Incr >=15%	1 Particpants	0 Particpants	2 Particpants	0 Particpants
Incidence of Post-baseline Newly Occurring or Worsening PCS Vital Signs Bradycardia Event <=50, Decr >=15%	9 Particpants	8 Particpants	3 Particpants	2 Particpants

PRIMARY outcome

Timeframe: 28 Weeks

Population: Japanese Safety Population

Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values

Outcome measures

Outcome measures
Measure	BGF MDI 320/14.4/9.6 ug n=139 Participants Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug n=138 Participants Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug	BFF MDI 320/9.6 ug n=70 Participants Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug	Symbicort TBH 400/12 ug n=69 Participants Open Label Symbicort Turbuhaler 400/12 ug BID
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values >=500 if <500 msec at BL and change >=15 msec	1 Participants	0 Participants	0 Participants	0 Participants
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values >=530 if >=500 msec at BL and >=15 msec	0 Participants	0 Participants	0 Participants	0 Participants
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values >= 500 msec and >= 15 msec change from BL	1 Participants	0 Participants	0 Participants	0 Participants
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values Increase from baseline is >=60 msec	1 Participants	1 Participants	0 Participants	0 Participants
Incidence of Post-baseline Newly Occurring or Worsening PCS ECG Values Value is >500 msec and increase >=60 msec	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

BGF MDI 320/14.4/9.6 ug

Serious events: 21 serious events

Other events: 82 other events

Deaths: 3 deaths

GFF MDI 14.4/9.6 ug

Serious events: 30 serious events

Other events: 75 other events

Deaths: 1 deaths

BFF MDI 320/9.6 ug

Serious events: 11 serious events

Other events: 40 other events

Deaths: 1 deaths

Symbicort TBH 400/12 ug BID

Serious events: 14 serious events

Other events: 38 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	BGF MDI 320/14.4/9.6 ug n=139 participants at risk Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug n=138 participants at risk Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug	BFF MDI 320/9.6 ug n=70 participants at risk Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug	Symbicort TBH 400/12 ug BID n=69 participants at risk Open Label Symbicort Turbuhaler 400/12 ug BID
Infections and infestations Nasopharyngitis	32.4% 45/139 • Number of events 69 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	31.2% 43/138 • Number of events 57 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	31.4% 22/70 • Number of events 33 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	34.8% 24/69 • Number of events 30 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.
Infections and infestations Bronchitis	10.1% 14/139 • Number of events 20 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	8.0% 11/138 • Number of events 20 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	11.4% 8/70 • Number of events 10 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	10.1% 7/69 • Number of events 8 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.
Infections and infestations Influenza	3.6% 5/139 • Number of events 5 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	4.3% 6/138 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	4.3% 3/70 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	8.7% 6/69 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Upper Respiratory tract inflammation	3.6% 5/139 • Number of events 8 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	5.1% 7/138 • Number of events 9 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	7.1% 5/70 • Number of events 7 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	0.00% 0/69 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	7.2% 10/139 • Number of events 10 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	0.72% 1/138 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	12.9% 9/70 • Number of events 9 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	4.3% 3/69 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	11.5% 16/139 • Number of events 16 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	4.3% 6/138 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	8.6% 6/70 • Number of events 7 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	4.3% 3/69 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.
Gastrointestinal disorders Constipation	4.3% 6/139 • Number of events 6 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	3.6% 5/138 • Number of events 8 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	5.7% 4/70 • Number of events 4 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	2.9% 2/69 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.
Skin and subcutaneous tissue disorders Eczema	0.72% 1/139 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	2.2% 3/138 • Number of events 3 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	5.7% 4/70 • Number of events 4 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	5.8% 4/69 • Number of events 4 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.
Infections and infestations Upper respiratory tract infection	7.2% 10/139 • Number of events 11 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	5.8% 8/138 • Number of events 12 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	1.4% 1/70 • Number of events 1 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.	2.9% 2/69 • Number of events 2 • Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug up to an average of 30 weeks. The Study safety population was defined as all subjects who signed ICF for PT010006 and received any amount of study treatment.

Additional Information

Paul M. Dorinsky, MD

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.
Publication restrictions are in place

Restriction type: OTHER