Trial Outcomes & Findings for A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD) (NCT NCT01458340)

Last Updated: 2022-04-04

Results Overview

The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

295 participants

Primary outcome timeframe

Baseline and Day 42

Results posted on

2022-04-04

Participant Flow

295 participants with attention-deficit/hyperactivity disorder (ADHD) were enrolled across 19 sites in the United States between December 2011 and September 2013. Participants were randomized in a 1:1:1 ratio, to receive active treatment, consisting of 5 mg or 20 mg of TD-9855 or placebo daily for 6 weeks.

A total of 295 subjects were randomized into the study and 293 received any amount of study drug.

Participant milestones

Participant milestones
Measure	Placebo Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg Participants received 5 mg TD-9855 as oral capsules daily from Day 1 to Day 42.	TD-9855 20 mg Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Overall Study STARTED	97	99	99
Overall Study Received Study Treatment	97	98	98
Overall Study COMPLETED	70	78	76
Overall Study NOT COMPLETED	27	21	23

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg Participants received 5 mg TD-9855 as oral capsules daily from Day 1 to Day 42.	TD-9855 20 mg Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Overall Study Adverse Event	5	4	2
Overall Study Lost to Follow-up	3	3	10
Overall Study Miscellaneous	0	1	0
Overall Study Physician Decision	1	1	2
Overall Study Protocol Violation	6	6	5
Overall Study Withdrawal by Subject	12	6	4

Baseline Characteristics

A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=97 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=99 Participants Participants received 5 mg TD-9855 as oral capsules daily from Day 1 to Day 42.	TD-9855 20 mg n=99 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.	Total n=295 Participants Total of all reporting groups
Age, Continuous	30.8 years STANDARD_DEVIATION 7.9 • n=93 Participants	30.9 years STANDARD_DEVIATION 7.4 • n=4 Participants	30.5 years STANDARD_DEVIATION 7.6 • n=27 Participants	30.8 years STANDARD_DEVIATION 7.6 • n=483 Participants
Sex: Female, Male Female	30 Participants n=93 Participants	41 Participants n=4 Participants	33 Participants n=27 Participants	104 Participants n=483 Participants
Sex: Female, Male Male	67 Participants n=93 Participants	58 Participants n=4 Participants	66 Participants n=27 Participants	191 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=93 Participants	14 Participants n=4 Participants	16 Participants n=27 Participants	42 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	84 Participants n=93 Participants	85 Participants n=4 Participants	82 Participants n=27 Participants	251 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Race/Ethnicity, Customized White	88 Participants n=93 Participants	86 Participants n=4 Participants	84 Participants n=27 Participants	258 Participants n=483 Participants
Race/Ethnicity, Customized Black or African American	9 Participants n=93 Participants	9 Participants n=4 Participants	12 Participants n=27 Participants	30 Participants n=483 Participants
Race/Ethnicity, Customized Asian	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants	4 Participants n=483 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race/Ethnicity, Customized Other	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants	2 Participants n=483 Participants
Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score	38.4 score on a scale STANDARD_DEVIATION 7.1 • n=93 Participants	39.1 score on a scale STANDARD_DEVIATION 7.3 • n=4 Participants	38.2 score on a scale STANDARD_DEVIATION 7.1 • n=27 Participants	38.6 score on a scale STANDARD_DEVIATION 7.2 • n=483 Participants
Barkley Deficits in Executive Functioning Scale - Short Form (BDEFS-SF): Self Report Total Score	52.7 score on a scale STANDARD_DEVIATION 11.9 • n=93 Participants	53.0 score on a scale STANDARD_DEVIATION 10.5 • n=4 Participants	52.3 score on a scale STANDARD_DEVIATION 10.3 • n=27 Participants	52.7 score on a scale STANDARD_DEVIATION 10.9 • n=483 Participants

PRIMARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants.

Outcome measures

Outcome measures
Measure	Placebo n=97 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=99 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=99 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Change From Baseline in AISRS Total Score at Day 42	-12.1 score on a scale Standard Error 1.21	-11.7 score on a scale Standard Error 1.17	-12.2 score on a scale Standard Error 1.18

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis and with a with baseline BDEFS-SF Total Score \>= 45 are included.

The BDEFS-SF: Self-Report is an empirically based tool for evaluating dimensions of adult executive functioning in daily life. The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80 with a negative change from baseline indicating an improvement in functioning.

Outcome measures

Outcome measures
Measure	Placebo n=75 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=77 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=79 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42	-9.8 score on a scale Standard Error 1.56	-9.7 score on a scale Standard Error 1.51	-11.6 score on a scale Standard Error 1.49

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.

The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS inattentive subscale that measures all 9 inattentive symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The AISRS inattentive subscale score ranges from 0 to 27 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=82 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=79 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Change From Baseline in AISRS Inattentive Subscale at Day 42	-6.2 score on a scale Standard Deviation 6.58	-6.8 score on a scale Standard Deviation 6.57	-7.2 score on a scale Standard Deviation 6.72

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.

The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS hyperactive-impulsive subscale measures all 9 hyperactive/impulsive symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The AISRS hyperactive-impulsive subscale score ranges from 0 to 27 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=82 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=79 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42	-5.2 score on a scale Standard Deviation 5.17	-5.1 score on a scale Standard Deviation 5.51	-5.0 score on a scale Standard Deviation 5.11

SECONDARY outcome

Timeframe: Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.

The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS total scale measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54. A responder is defined as a participant with \>=30% reduction from baseline in AISRS total score.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=82 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=79 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Percentage of Participants With an AISRS Response at Day 42	46.1 percentage of participants	43.9 percentage of participants	51.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.

The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participants' illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7,extremely ill. A negative change from baseline indicates a reduction in illness.

Outcome measures

Outcome measures
Measure	Placebo n=76 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=82 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=79 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42	-1.0 score on a scale Standard Deviation 1.09	-0.8 score on a scale Standard Deviation 1.13	-1.0 score on a scale Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.

The ASRS is a checklist consisting of the 18 Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV-TR) criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS total score ranges from 0-72 with a negative change from baseline indicating a reduction in frequency of symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=79 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=86 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=84 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42	-12.5 score on a scale Standard Deviation 15.25	-12.1 score on a scale Standard Deviation 14.49	-14.0 score on a scale Standard Deviation 13.89

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.

The ASRS inattentive subscale is a checklist consisting of 9 DSM-IV-TR inattentive criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS inattentive subscale score ranges from 0-36 with a negative change from baseline indicating a reduction in frequency of symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=79 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=86 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=84 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Change From Baseline in ASRS Inattentive Subscale at Day 42	-6.7 score on a scale Standard Deviation 8.30	-6.9 score on a scale Standard Deviation 8.26	-7.7 score on a scale Standard Deviation 7.99

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.

The ASRS hyperactive-impulsive subscale is a checklist consisting of 9 DSM-IV-TR hyperactive/impulsive criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS hyperactive-impulsive subscale score ranges from 0-36 with a negative change from baseline indicating a reduction in frequency of symptoms.

Outcome measures

Outcome measures
Measure	Placebo n=79 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=86 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=84 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42	-5.9 score on a scale Standard Deviation 7.62	-5.2 score on a scale Standard Deviation 6.94	-6.3 score on a scale Standard Deviation 6.71

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.

MADRS is a 10-item investigator-rated scale that assesses the range of symptoms that are most frequently observed in patients with major depression. The 10 selected items are rated on a scale of 0 (no depression) to 6 (highest level of depression) with anchors at 2-point intervals. Total scores on the MADRS range from 0 to 60 with a negative change from baseline indicating an improvement in levels of depression.

Outcome measures

Outcome measures
Measure	Placebo n=79 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=86 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=84 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42	-1.3 score on a scale Standard Deviation 3.54	-0.3 score on a scale Standard Deviation 3.25	-0.9 score on a scale Standard Deviation 2.86

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.

The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80. A reliable change is defined as a decrease in total BDEFS-SF score of 12 or more relative to the baseline value.

Outcome measures

Outcome measures
Measure	Placebo n=79 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=86 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=84 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42	30.4 percentage of participants	32.6 percentage of participants	47.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis and with a with baseline BDEFS-SF Total Score \>= 45 are included.

Outcome measures

Outcome measures
Measure	Placebo n=62 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=66 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=68 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42	29.0 percentage of participants	28.8 percentage of participants	38.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Day 42

Population: The ITT population included all randomized participants. Only participants with data available for analysis are included.

The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. A negative change from baseline in symptom count indicates an improvement in functioning. Only symptoms rated as occurring often or very often on the BDEFS-SF are included in the symptom count. Mean change from baseline in symptom count is reported

Outcome measures

Outcome measures
Measure	Placebo n=79 Participants Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=86 Participants Participants received 5 mg TD-9855 as oral capsules once daily from Day 1 to Day 42.	TD-9855 20 mg n=84 Participants Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Change From Baseline in BDEFS-SF Symptom Count at Day 42	-3.3 count of symptoms Standard Deviation 4.86	-4.2 count of symptoms Standard Deviation 5.72	-4.5 count of symptoms Standard Deviation 5.10

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 68 other events

Deaths: 0 deaths

TD-9855 5mg

Serious events: 0 serious events

Other events: 75 other events

Deaths: 0 deaths

TD-9855 20 mg

Serious events: 0 serious events

Other events: 80 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=97 participants at risk Participants received a matching placebo as oral capsules daily from Day 1 to Day 42.	TD-9855 5mg n=98 participants at risk Participants received 5 mg TD-9855 as oral capsules daily from Day 1 to Day 42.	TD-9855 20 mg n=98 participants at risk Participants received 10 mg TD-9855 as oral capsules daily from Day 1 to Day 7. Participants' doses were increased to 20 mg from Day 8 to Day 42 based on the safety and tolerability of the 10 mg dose. Participants who in the investigator's opinion were not able to tolerate the 20 mg dose, continued to receive the 10 mg dose from Day 8 to Day 42.
Skin and subcutaneous tissue disorders Dermatitis contact	1.0% 1/97 • Day 1 to Day 56 The Safety Analysis Group included all participants who received study treatment.	0.00% 0/98 • Day 1 to Day 56 The Safety Analysis Group included all participants who received study treatment.	0.00% 0/98 • Day 1 to Day 56 The Safety Analysis Group included all participants who received study treatment.

Other adverse events

Additional Information

Medical Monitor

Theravance Biopharma

Phone: 1-855-633-8479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place