Trial Outcomes & Findings for 24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo (NCT NCT02347072)
NCT ID: NCT02347072
Last Updated: 2017-04-19
Results Overview
Normalized Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) 0-24
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29
Results posted on
2017-04-19
Participant Flow
This study was conducted at 10 sites in the US from February 2015 to August 2015. The study was anticipated to run for approximately 9 months but not expected to exceed 12 months.
Study to assess the efficacy and safety of GFF MDI 14.4/9.6µg relative to either Placebo MDI or Spiriva Respimat 5µg. Subjects were randomized into 1 of 6 treatment sequences, and all treatment sequences included all 3 treatments. By-treatment sequence tabulations of the data were not pre-specified.
Participant milestones
| Measure |
Overall Study
All Subjects Randomized
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
GFF MDI 14.4/9.6 µg
|
75
|
|
Overall Study
Placebo MDI
|
72
|
|
Overall Study
Spiriva Respimat 5 µg
|
73
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
Overall Study
All Subjects Randomized
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Disc due to Protocol-specified Criteria
|
6
|
Baseline Characteristics
24-hour Lung Function in Subjects With Moderate to Very Severe COPD After Treatment With PT003, Open-Label Spiriva® Respimat® as an Active Control, and Placebo
Baseline characteristics by cohort
| Measure |
All Subjects
n=75 Participants
|
|---|---|
|
Age, Continuous
|
61.8 Years
STANDARD_DEVIATION 9.1 • n=99 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, 12, 12.25, 12.5, 13, 14, 16, 22, and 24 hours post the morning dose on Day 29Population: Subjects in the Modified Intent to Treat (MITT) Population who had a sufficient number of post dose FEV1 measurements
Normalized Forced Expiratory Volume in 1 second (FEV1) Area Under the Curve (AUC) 0-24
Outcome measures
| Measure |
GFF MDI
n=65 Participants
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=67 Participants
Spiriva Respimat 5μg
|
Placebo
n=65 Participants
Placebo MDI
|
|---|---|---|---|
|
Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) 0-24
|
0.192 Liters
Interval 0.141 to 0.243
|
0.112 Liters
Interval 0.061 to 0.162
|
-0.072 Liters
Interval -0.123 to -0.022
|
SECONDARY outcome
Timeframe: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the evening dose on Day 29Population: Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements
Normalized FEV1 AUC12-24
Outcome measures
| Measure |
GFF MDI
n=65 Participants
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=67 Participants
Spiriva Respimat 5μg
|
Placebo
n=65 Participants
Placebo MDI
|
|---|---|---|---|
|
FEV1 AUC12-24
|
0.159 Liters
Interval 0.104 to 0.214
|
0.039 Liters
Interval -0.015 to 0.094
|
-0.118 Liters
Interval -0.173 to -0.063
|
SECONDARY outcome
Timeframe: Pre dose, 15 and 30 minutes, 1, 2, 4, 8, and 12 hours post the morning dose on Day 29Population: Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements
Normalized FEV1 AUC0-12
Outcome measures
| Measure |
GFF MDI
n=67 Participants
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=68 Participants
Spiriva Respimat 5μg
|
Placebo
n=66 Participants
Placebo MDI
|
|---|---|---|---|
|
FEV1 AUC0-12
|
0.226 Liters
Interval 0.175 to 0.276
|
0.178 Liters
Interval 0.127 to 0.228
|
-0.026 Liters
Interval -0.077 to 0.025
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: MITT Population
Peak Change From Baseline in FEV1 Evening
Outcome measures
| Measure |
GFF MDI
n=65 Participants
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=67 Participants
Spiriva Respimat 5μg
|
Placebo
n=65 Participants
Placebo MDI
|
|---|---|---|---|
|
Peak Change From Baseline in FEV1 Evening
|
0.395 Liters
Interval 0.334 to 0.456
|
0.230 Liters
Interval 0.17 to 0.291
|
0.058 Liters
Interval -0.003 to 0.119
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements
Peak Change From Baseline in FEV1 Morning
Outcome measures
| Measure |
GFF MDI
n=67 Participants
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=68 Participants
Spiriva Respimat 5μg
|
Placebo
n=67 Participants
Placebo MDI
|
|---|---|---|---|
|
Peak Change From Baseline in FEV1 Morning
|
0.406 Liters
Interval 0.351 to 0.462
|
0.325 Liters
Interval 0.27 to 0.381
|
0.129 Liters
Interval 0.073 to 0.185
|
SECONDARY outcome
Timeframe: Day 29Population: Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements
Morning Pre-Dose Trough FEV1 on Day 29
Outcome measures
| Measure |
GFF MDI
n=67 Participants
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=68 Participants
Spiriva Respimat 5μg
|
Placebo
n=66 Participants
Placebo MDI
|
|---|---|---|---|
|
Morning Pre-Dose Trough FEV1 on Day 29
|
0.140 Liters
Interval 0.095 to 0.185
|
0.097 Liters
Interval 0.053 to 0.142
|
-0.020 Liters
Interval -0.066 to 0.025
|
SECONDARY outcome
Timeframe: Day 30Population: Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements
Morning Pre-Dose Trough FEV1 on Day 30
Outcome measures
| Measure |
GFF MDI
n=66 Participants
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=66 Participants
Spiriva Respimat 5μg
|
Placebo
n=66 Participants
Placebo MDI
|
|---|---|---|---|
|
Morning Pre-Dose Trough FEV1 on Day 30
|
0.129 Liters
Interval 0.073 to 0.185
|
0.072 Liters
Interval 0.015 to 0.128
|
-0.073 Liters
Interval -0.13 to -0.017
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements
Peak Change From Baseline in IC Evening
Outcome measures
| Measure |
GFF MDI
n=62 Participants
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=67 Participants
Spiriva Respimat 5μg
|
Placebo
n=63 Participants
Placebo MDI
|
|---|---|---|---|
|
Peak Change From Baseline in IC (Inspiratory Capacity) Evening
|
0.421 Liters
Interval 0.343 to 0.498
|
0.297 Liters
Interval 0.221 to 0.372
|
0.109 Liters
Interval 0.032 to 0.186
|
SECONDARY outcome
Timeframe: Baseline and Day 29Population: Subjects in the MITT Population who had a sufficient number of post dose FEV1 measurements
Peak Change From Baseline in IC Morning
Outcome measures
| Measure |
GFF MDI
n=67 Participants
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=66 Participants
Spiriva Respimat 5μg
|
Placebo
n=65 Participants
Placebo MDI
|
|---|---|---|---|
|
Peak Change From Baseline in IC Morning
|
0.454 Liters
Interval 0.388 to 0.52
|
0.374 Liters
Interval 0.307 to 0.44
|
0.206 Liters
Interval 0.139 to 0.273
|
Adverse Events
GFF MDI
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Spiriva Respimat
Serious events: 2 serious events
Other events: 5 other events
Deaths: 0 deaths
Placebo
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GFF MDI
n=75 participants at risk
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=73 participants at risk
Spiriva Respimat 5μg
|
Placebo
n=72 participants at risk
Placebo MDI
|
|---|---|---|---|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/75 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
1.4%
1/73 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/72 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/75 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/73 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
1.4%
1/72 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/73 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
1.4%
1/72 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Infections and infestations
Influenza
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/73 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/72 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Infections and infestations
Pneumonia
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/73 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/72 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Infections and infestations
Sepsis
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/73 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/72 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/75 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/73 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
1.4%
1/72 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/75 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
1.4%
1/73 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/72 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
Other adverse events
| Measure |
GFF MDI
n=75 participants at risk
Glycopyrronium Formoterol GFF Metered Dose Inhaler MDI 14.4/9.6µg
|
Spiriva Respimat
n=73 participants at risk
Spiriva Respimat 5μg
|
Placebo
n=72 participants at risk
Placebo MDI
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
2.7%
2/75 • Number of events 2 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/73 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
1.4%
1/72 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/75 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
4.1%
3/73 • Number of events 3 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/72 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/75 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
2.7%
2/73 • Number of events 2 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/72 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Nervous system disorders
Tremor
|
4.0%
3/75 • Number of events 3 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/73 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/72 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Nervous system disorders
Headache
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
1.4%
1/73 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
2.8%
2/72 • Number of events 3 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
1.4%
1/73 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
2.8%
2/72 • Number of events 2 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.3%
1/75 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
0.00%
0/73 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
2.8%
2/72 • Number of events 2 • Adverse events were collected from the time the subject signed consent up to the follow-up phone call 7-14 days after last dose of study drug.
The Safety Population was defined as all subjects who were randomized to treatment and received at least one dose of study treatment. Serious adverse events collected from time of consent up to 14 days after last dose of study drug.
|
Additional Information
Colin Reisner, MD, FCCP, FAAAAI
Pearl Therapeutics Inc.
Phone: 650-350-2600
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 its opinions, or the opinions of the publication committee, if these differ with the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER