Trial Outcomes & Findings for PT003 MDI Dose Confirmation Study (NCT NCT01349816)
NCT ID: NCT01349816
Last Updated: 2017-04-27
Results Overview
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
185 participants
Primary outcome timeframe
Day 7
Results posted on
2017-04-27
Participant Flow
Conducted at 14 US sites from July-November 2011. Entire study period of study participation was a maximum of 9 weeks.
Study was a chronic dosing study; each participant received 2 of 6 possible treatments; each treatment period was separated by a washout period of at least 7 days. Patients were randomized into one of 30 treatment sequences. Each sequence included exactly 2 of the 6 treatment groups for this study.
Participant milestones
| Measure |
Overall Study
Overall Study
|
|---|---|
|
Overall Study
STARTED
|
185
|
|
Overall Study
GP MDI 36 µg
|
61
|
|
Overall Study
GFF MDI 36/7.2 µg
|
58
|
|
Overall Study
GFF MDI 36/9.6 µg
|
56
|
|
Overall Study
GFF MDI 18/9.6 µg
|
57
|
|
Overall Study
GFF MDI 9/9.6 µg
|
57
|
|
Overall Study
FF MDI 9.6 µg
|
61
|
|
Overall Study
COMPLETED
|
155
|
|
Overall Study
NOT COMPLETED
|
30
|
Reasons for withdrawal
| Measure |
Overall Study
Overall Study
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Adverse Event
|
14
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Protocol Violation
|
1
|
|
Overall Study
Protocol-specified criteria
|
8
|
Baseline Characteristics
PT003 MDI Dose Confirmation Study
Baseline characteristics by cohort
| Measure |
Overall Study
n=185 Participants
All patients randomized and treated
|
|---|---|
|
Age, Continuous
|
62.1 Years
STANDARD_DEVIATION 9.18 • n=5 Participants
|
|
Sex: Female, Male
Female
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 7Population: Modified Intent to Treat (MITT) Population is made of participants who completed both treatment periods and had Pre-dose Day 1 data for both and no protocol deviations believed to have a potential impact on efficacy results. Subjects must have had data for the given endpoint to be included.
Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) 0-12 relative to baseline following chronic dosing (1 week).
Outcome measures
| Measure |
GFF MDI 36/7.2 µg
n=49 Participants
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=42 Participants
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=44 Participants
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=50 Participants
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=49 Participants
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=50 Participants
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
FEV1 AUC0-12
|
1.467 Liters
Interval 1.424 to 1.511
|
1.462 Liters
Interval 1.418 to 1.508
|
1.493 Liters
Interval 1.448 to 1.539
|
1.499 Liters
Interval 1.455 to 1.544
|
1.399 Liters
Interval 1.358 to 1.441
|
1.465 Liters
Interval 1.423 to 1.509
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population
Peak change from baseline in FEV1 through 2 hours
Outcome measures
| Measure |
GFF MDI 36/7.2 µg
n=49 Participants
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=43 Participants
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=45 Participants
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=52 Participants
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=51 Participants
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=51 Participants
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
Peak Change From Baseline in FEV1
|
0.312 Liters
Interval 0.265 to 0.359
|
0.308 Liters
Interval 0.259 to 0.358
|
0.344 Liters
Interval 0.295 to 0.393
|
0.350 Liters
Interval 0.304 to 0.397
|
0.248 Liters
Interval 0.201 to 0.294
|
0.307 Liters
Interval 0.26 to 0.353
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population
At least 10% improvement in mean FEV1
Outcome measures
| Measure |
GFF MDI 36/7.2 µg
n=50 Participants
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=43 Participants
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=45 Participants
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=52 Participants
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=51 Participants
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=51 Participants
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
Time to Onset of Action
15 minutes
|
28 Participants
Interval 0.265 to 0.359
|
21 Participants
Interval 0.259 to 0.358
|
20 Participants
Interval 0.295 to 0.393
|
30 Participants
Interval 0.304 to 0.397
|
15 Participants
Interval 0.201 to 0.294
|
24 Participants
Interval 0.26 to 0.353
|
|
Time to Onset of Action
30 minutes
|
10 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
14 Participants
|
14 Participants
|
|
Time to Onset of Action
1 hour
|
4 Participants
|
3 Participants
|
9 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
|
Time to Onset of Action
2 hours
|
4 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Time to Onset of Action
No onset within 2 hours
|
4 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
12 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population
Proportion of subjects achieving \>=12% improvement in FEV1 relative to baseline
Outcome measures
| Measure |
GFF MDI 36/7.2 µg
n=50 Participants
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=43 Participants
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=45 Participants
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=52 Participants
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=51 Participants
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=51 Participants
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
At Least 12% Improvement in FEV1
15 minutes
|
22 Participants
Interval 0.265 to 0.359
|
17 Participants
Interval 0.259 to 0.358
|
18 Participants
Interval 0.295 to 0.393
|
27 Participants
Interval 0.304 to 0.397
|
13 Participants
Interval 0.201 to 0.294
|
22 Participants
Interval 0.26 to 0.353
|
|
At Least 12% Improvement in FEV1
30 minutes
|
14 Participants
|
10 Participants
|
8 Participants
|
7 Participants
|
12 Participants
|
10 Participants
|
|
At Least 12% Improvement in FEV1
1 hour
|
2 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
At Least 12% Improvement in FEV1
2 hours
|
2 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
5 Participants
|
|
At Least 12% Improvement in FEV1
No onset within 2 hours
|
10 Participants
|
8 Participants
|
8 Participants
|
8 Participants
|
17 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: MITT Population
Mean inspiratory capacity (IC) of 1 and 2 hours post-dose minus baseline
Outcome measures
| Measure |
GFF MDI 36/7.2 µg
n=48 Participants
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=43 Participants
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=45 Participants
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=52 Participants
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=51 Participants
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=51 Participants
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
Peak Change in IC
|
0.323 Liters
Interval 0.249 to 0.397
|
0.242 Liters
Interval 0.165 to 0.319
|
0.339 Liters
Interval 0.264 to 0.415
|
0.326 Liters
Interval 0.254 to 0.398
|
0.228 Liters
Interval 0.156 to 0.3
|
0.316 Liters
Interval 0.244 to 0.388
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population
Change from baseline in morning pre-dose FEV1 (average of 60- and 30-minute pre-dose values on Day 7)
Outcome measures
| Measure |
GFF MDI 36/7.2 µg
n=49 Participants
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=43 Participants
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=45 Participants
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=52 Participants
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=51 Participants
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=51 Participants
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
Morning Pre-dose FEV1
|
0.152 Liters
Interval 0.105 to 0.199
|
0.110 Liters
Interval 0.061 to 0.159
|
0.122 Liters
Interval 0.073 to 0.17
|
0.131 Liters
Interval 0.085 to 0.177
|
0.100 Liters
Interval 0.053 to 0.146
|
0.103 Liters
Interval 0.057 to 0.149
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population
Peak change from baseline in FEV1 through 6 hours
Outcome measures
| Measure |
GFF MDI 36/7.2 µg
n=50 Participants
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=42 Participants
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=45 Participants
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=51 Participants
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=51 Participants
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=51 Participants
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
FEV1 Through 6 Hours
|
0.362 Liters
Interval 0.309 to 0.414
|
0.356 Liters
Interval 0.3 to 0.412
|
0.388 Liters
Interval 0.334 to 0.443
|
0.415 Liters
Interval 0.363 to 0.467
|
0.283 Liters
Interval 0.231 to 0.336
|
0.355 Liters
Interval 0.302 to 0.408
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population
Peak change from baseline in inspiratory capacity (IC) (mean of 1 and 2 hours post-dose minus baseline)
Outcome measures
| Measure |
GFF MDI 36/7.2 µg
n=48 Participants
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=43 Participants
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=45 Participants
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=52 Participants
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=51 Participants
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=51 Participants
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
Peak Change From Baseline in IC
|
0.333 Liters
Interval 0.246 to 0.42
|
0.267 Liters
Interval 0.177 to 0.357
|
0.340 Liters
Interval 0.252 to 0.429
|
0.351 Liters
Interval 0.267 to 0.436
|
0.228 Liters
Interval 0.143 to 0.313
|
0.354 Liters
Interval 0.269 to 0.439
|
SECONDARY outcome
Timeframe: Day 7Population: MITT Population
Change from baseline in mean evening 12-hour post-dose trough FEV1
Outcome measures
| Measure |
GFF MDI 36/7.2 µg
n=48 Participants
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=43 Participants
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=44 Participants
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=51 Participants
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=49 Participants
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=50 Participants
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
Mean Evening Trough FEV1
|
0.080 Liters
Interval 0.032 to 0.129
|
0.073 Liters
Interval 0.023 to 0.123
|
0.105 Liters
Interval 0.055 to 0.154
|
0.112 Liters
Interval 0.064 to 0.159
|
0.081 Liters
Interval 0.033 to 0.129
|
0.120 Liters
Interval 0.073 to 0.168
|
Adverse Events
GFF MDI 36/7.2 µg
Serious events: 1 serious events
Other events: 9 other events
Deaths: 0 deaths
GFF MDI 36/9.6 µg
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
GFF MDI 18/9.6 µg
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
GFF MDI 9/9.6 µg
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
GP MDI 36 µg
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
FF MDI 9.6 µg
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
GFF MDI 36/7.2 µg
n=58 participants at risk
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=56 participants at risk
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=57 participants at risk
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=57 participants at risk
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=61 participants at risk
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=61 participants at risk
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/58 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/56 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/57 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/57 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/61 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
1.7%
1/58 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/56 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/57 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/57 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/61 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/61 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/58 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/56 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/57 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/57 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
1.6%
1/61 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/61 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
Other adverse events
| Measure |
GFF MDI 36/7.2 µg
n=58 participants at risk
GFF MDI 36/7.2 µg BID
|
GFF MDI 36/9.6 µg
n=56 participants at risk
GFF MDI 36/9.6 µg BID
|
GFF MDI 18/9.6 µg
n=57 participants at risk
GFF MDI 18/9.6 µg BID
|
GFF MDI 9/9.6 µg
n=57 participants at risk
GFF MDI 9/9.6 µg BID
|
GP MDI 36 µg
n=61 participants at risk
GP MDI 36 µg BID
|
FF MDI 9.6 µg
n=61 participants at risk
FF MDI 9.6 µg BID
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Dry mouth
|
5.2%
3/58 • Number of events 3 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
5.4%
3/56 • Number of events 3 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
1.8%
1/57 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
8.8%
5/57 • Number of events 5 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
3.3%
2/61 • Number of events 2 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
6.6%
4/61 • Number of events 4 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Nervous system disorders
Tremor
|
3.4%
2/58 • Number of events 3 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/56 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/57 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
3.5%
2/57 • Number of events 2 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/61 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
6.6%
4/61 • Number of events 4 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
|
Nervous system disorders
Headache
|
6.9%
4/58 • Number of events 4 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
1.8%
1/56 • Number of events 1 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/57 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/57 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/61 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
0.00%
0/61 • Adverse events were collected from the time the subject signed consent up to the follow-up (Final) visit or premature discontinuation visit.
Safety population included all participants who received at least one dose of study drug, with safety data available. Serious adverse events were collected from the time the subject signed consent up to 14 days following the last dose of study drug.
|
Additional Information
Colin Reisner, MD, FCCP, FAAAAI
Pearl Therapeutics, Inc
Phone: 650-305-2600
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