Trial Outcomes & Findings for SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia. (NCT NCT03331042)

Results Overview

TST efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-defined total sleep time (TST)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

85 participants

Primary outcome timeframe

8 hours

Results posted on

2019-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Sequence 1 SM-1 (Treatment Period 1), D+Z (Treatment Period 2), D+L (Treatment Period 3), Placebo (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.	Sequence 2 D+Z (Treatment Period 1), D+L (Treatment Period 2), Placebo (Treatment Period 3), SM-1 (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.	Sequence 3 D+L (Treatment Period 1), Placebo (Treatment Period 2), SM-1 (Treatment Period 3), D+Z (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.	Sequence 4 Placebo (Treatment Period 1), SM-1 (Treatment Period 2), D+Z (Treatment Period 3), D+L (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.
Overall Study STARTED	22	21	21	21
Overall Study COMPLETED	21	21	20	20
Overall Study NOT COMPLETED	1	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1 SM-1 (Treatment Period 1), D+Z (Treatment Period 2), D+L (Treatment Period 3), Placebo (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.	Sequence 3 D+L (Treatment Period 1), Placebo (Treatment Period 2), SM-1 (Treatment Period 3), D+Z (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.	Sequence 4 Placebo (Treatment Period 1), SM-1 (Treatment Period 2), D+Z (Treatment Period 3), D+L (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.
Overall Study Protocol Violation	1	0	0
Overall Study Physician Decision	0	1	0
Overall Study Lost to Follow-up	0	0	1

Baseline Characteristics

SM-1 vs 2 Comparators and Placebo in Participants With a History of Transient Insomnia.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence 1 n=22 Participants SM-1 (Treatment Period 1), D+Z (Treatment Period 2), D+L (Treatment Period 3), Placebo (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.	Sequence 2 n=21 Participants D+Z (Treatment Period 1), D+L (Treatment Period 2), Placebo (Treatment Period 3), SM-1 (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.	Sequence 3 n=21 Participants D+L (Treatment Period 1), Placebo (Treatment Period 2), SM-1 (Treatment Period 3), D+Z (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.	Sequence 4 n=21 Participants Placebo (Treatment Period 1), SM-1 (Treatment Period 2), D+Z (Treatment Period 3), D+L (Treatment Period 4). SM-1: 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam. D+Z: 2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem. D+L: 2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam. Placebo: Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.	Total n=85 Participants Total of all reporting groups
Age, Continuous	38.7 years STANDARD_DEVIATION 13.68 • n=5 Participants	39.3 years STANDARD_DEVIATION 13.29 • n=7 Participants	36.1 years STANDARD_DEVIATION 11.68 • n=5 Participants	41.6 years STANDARD_DEVIATION 11.77 • n=4 Participants	38.9 years STANDARD_DEVIATION 12.57 • n=21 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	10 Participants n=7 Participants	9 Participants n=5 Participants	11 Participants n=4 Participants	43 Participants n=21 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	11 Participants n=7 Participants	12 Participants n=5 Participants	10 Participants n=4 Participants	42 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	12 Participants n=5 Participants	13 Participants n=7 Participants	10 Participants n=5 Participants	15 Participants n=4 Participants	50 Participants n=21 Participants
Race (NIH/OMB) White	7 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants	4 Participants n=4 Participants	24 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	6 Participants n=21 Participants

PRIMARY outcome

Timeframe: 8 hours

Population: Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug.

TST efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-defined total sleep time (TST)

Outcome measures

Outcome measures
Measure	SM-1 n=84 Participants Subjects received a single dose of the triple drug combination	Diphenhydramine Plus Zolpidem n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam	Diphenhydramine Plus Lorazepam n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem	Placebo n=83 Participants Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
Total Sleep Time (TST)	401.82 minutes Standard Deviation 68.074	404.83 minutes Standard Deviation 47.252	397.28 minutes Standard Deviation 56.982	307.38 minutes Standard Deviation 107.365

SECONDARY outcome

Timeframe: 8 hours

Population: Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug.

Efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep induction, the amount of time it takes the subject to fall asleep.

Outcome measures

Outcome measures
Measure	SM-1 n=84 Participants Subjects received a single dose of the triple drug combination	Diphenhydramine Plus Zolpidem n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam	Diphenhydramine Plus Lorazepam n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem	Placebo n=83 Participants Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
Latency to Persistent Sleep (LPS)	18.59 minutes Standard Deviation 18.548	23.10 minutes Standard Deviation 29.145	23.55 minutes Standard Deviation 29.125	39.25 minutes Standard Deviation 73.961

SECONDARY outcome

Timeframe: 8 hours

Population: Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug.

NAW efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep maintenance.

Outcome measures

Outcome measures
Measure	SM-1 n=84 Participants Subjects received a single dose of the triple drug combination	Diphenhydramine Plus Zolpidem n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam	Diphenhydramine Plus Lorazepam n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem	Placebo n=83 Participants Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
Number of Awakenings (NAW)	11.0 awakenings Standard Deviation 6.06	10.7 awakenings Standard Deviation 6.22	11.0 awakenings Standard Deviation 5.91	8.6 awakenings Standard Deviation 5.06

SECONDARY outcome

Timeframe: 8 hours

Population: Full analysis set consisted of all subjects who were randomized to a treatment sequence, and had taken any study drug.

WASO efficacy of SM-1 versus placebo, combination product diphenhydramine plus zolpidem and combination product diphenhydramine plus lorazepam measured by polysomnography (PSG)-measured sleep maintenance as the amount of time spent awake after falling asleep.

Outcome measures

Outcome measures
Measure	SM-1 n=84 Participants Subjects received a single dose of the triple drug combination	Diphenhydramine Plus Zolpidem n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam	Diphenhydramine Plus Lorazepam n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem	Placebo n=83 Participants Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
Wakefulness After Sleep Onset (WASO)	64.11 minutes Standard Deviation 66.673	58.83 minutes Standard Deviation 41.834	63.91 minutes Standard Deviation 49.841	140.06 minutes Standard Deviation 99.366

SECONDARY outcome

Timeframe: Up to Visit 5

Population: The Safety Population included all subjects that received any study drug, and were grouped by actual treatment.

Morning alertness measured by Karolinska Sleepiness Scale (KSS). KSS ranges from 1-9, with higher numbers indicating sleepier and lower numbers more alert.

Outcome measures

Outcome measures
Measure	SM-1 n=84 Participants Subjects received a single dose of the triple drug combination	Diphenhydramine Plus Zolpidem n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam	Diphenhydramine Plus Lorazepam n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem	Placebo n=83 Participants Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
Karolinska Sleepiness Scale (KSS) of Morning Alertness.	4.2 units on a scale Standard Deviation 1.99	3.9 units on a scale Standard Deviation 2.01	3.9 units on a scale Standard Deviation 2.02	3.9 units on a scale Standard Deviation 2.01

SECONDARY outcome

Timeframe: Up to Visit 5

Population: Safety Population included all subjects that received any study drug, and were grouped by actual treatment.

Morning alertness measured by DSST. The digit symbol substitution test assesses attention, psychomotor speed, complex scanning, visual tracking, and immediate memory. This test consists of 4 rows each with 25 small blank squares; above each square is a number between 1 and 9. At the top is a 'key,' which pairs each number (1 through 9) with an unfamiliar symbol. The participant has 90 seconds to work as quickly as possible (left to right across the rows) to fill in each blank square with the appropriate symbol based on the number above the square. Results are presented as total number correct; therefore, lower numbers indicate greater impairment. Scores on the DSST range from 0-93

Outcome measures

Outcome measures
Measure	SM-1 n=84 Participants Subjects received a single dose of the triple drug combination	Diphenhydramine Plus Zolpidem n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam	Diphenhydramine Plus Lorazepam n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem	Placebo n=83 Participants Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
Number Correct on Digit Symbol Substitution Test (DSST)	56.0 number correct Standard Deviation 14.21	57.6 number correct Standard Deviation 14.98	58.3 number correct Standard Deviation 16.20	60.4 number correct Standard Deviation 16.81

SECONDARY outcome

Timeframe: Up to 22 days.

Population: All subjects who were randomized to a treatment sequence, and had taken any study drug.

Subject reported TST from Post-Sleep Questionnaire (PSQ).

Outcome measures

Outcome measures
Measure	SM-1 n=84 Participants Subjects received a single dose of the triple drug combination	Diphenhydramine Plus Zolpidem n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam	Diphenhydramine Plus Lorazepam n=82 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem	Placebo n=83 Participants Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
Subjective Total Sleep Time (sTST)	441.1 minutes Standard Deviation 55.97	419.0 minutes Standard Deviation 79.60	422.9 minutes Standard Deviation 83.63	368.7 minutes Standard Deviation 107.47

SECONDARY outcome

Timeframe: Up to 22 days.

Population: All subjects who were randomized to a treatment sequence, and had taken any study drug.

Subject reported SOL, the amount of time the subject felt it took to fall asleep, from Post-Sleep Questionnaire (PSQ).

Outcome measures

Outcome measures
Measure	SM-1 n=84 Participants Subjects received a single dose of the triple drug combination	Diphenhydramine Plus Zolpidem n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam	Diphenhydramine Plus Lorazepam n=82 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem	Placebo n=83 Participants Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
Subjective Sleep Onset Latency (sSOL)	22.7 minutes Standard Error 24.30	27.7 minutes Standard Error 34.29	26.6 minutes Standard Error 51.81	34.8 minutes Standard Error 55.53

SECONDARY outcome

Timeframe: Up to 22 days.

Population: All subjects who were randomized to a treatment sequence, and had taken any study drug.

Subject reported NAW from Post-Sleep Questionnaire (PSQ).

Outcome measures

Outcome measures
Measure	SM-1 n=84 Participants Subjects received a single dose of the triple drug combination	Diphenhydramine Plus Zolpidem n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam	Diphenhydramine Plus Lorazepam n=80 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem	Placebo n=82 Participants Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
Subjective Number of Awakenings (sNAW)	2.0 awakenings Standard Deviation 1.73	2.2 awakenings Standard Deviation 2.19	2.2 awakenings Standard Deviation 1.47	2.8 awakenings Standard Deviation 1.83

SECONDARY outcome

Timeframe: Up to 22 days.

Population: All subjects who were randomized to a treatment sequence, and had taken any study drug.

Subject reported sleep quality, how well the subject felt he or she slept, from Post-Sleep Questionnaire (PSQ).

Outcome measures

Outcome measures
Measure	SM-1 n=84 Participants Subjects received a single dose of the triple drug combination	Diphenhydramine Plus Zolpidem n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Zolpidem; i.e., SM-1 without Lorazepam	Diphenhydramine Plus Lorazepam n=83 Participants Subjects received a single dose of the 2-drug product containing Diphenhydramine plus Lorazepam; i.e., SM-1 without Zolpidem	Placebo n=83 Participants Subjects received a single dose of a Placebo matching the appearance of the active treatments but containing no active drug components
Number of Participants According to Sleep Quality 1 = poor	5 Participants	3 Participants	7 Participants	15 Participants
Number of Participants According to Sleep Quality 2 = fair	13 Participants	17 Participants	15 Participants	39 Participants
Number of Participants According to Sleep Quality 3 = good	43 Participants	48 Participants	49 Participants	21 Participants
Number of Participants According to Sleep Quality 4 = excellent	23 Participants	15 Participants	12 Participants	8 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 hours

Effect of SM-1 and the two 2-drug combination products (diphenhydramine plus zolpidem and diphenhydramine plus lorazepam) on sleep stage distribution.

Outcome measures

Outcome data not reported

Adverse Events

SM-1

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Diphenhydramine Plus Zolpidem

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Diphenhydramine Plus Lorazepam

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	SM-1 n=84 participants at risk Triple drug combination	Diphenhydramine Plus Zolpidem n=83 participants at risk Diphenhydramine plus Zolpidem	Diphenhydramine Plus Lorazepam n=83 participants at risk Diphenhydramine plus Lorazepam	Placebo n=83 participants at risk Placebo
Nervous system disorders nightmare	1.2% 1/84 • Number of events 1 • From Day 1 until 7 days after the last dose of study drug.	0.00% 0/83 • From Day 1 until 7 days after the last dose of study drug.	0.00% 0/83 • From Day 1 until 7 days after the last dose of study drug.	0.00% 0/83 • From Day 1 until 7 days after the last dose of study drug.
Nervous system disorders somnolence	1.2% 1/84 • Number of events 1 • From Day 1 until 7 days after the last dose of study drug.	1.2% 1/83 • Number of events 1 • From Day 1 until 7 days after the last dose of study drug.	0.00% 0/83 • From Day 1 until 7 days after the last dose of study drug.	1.2% 1/83 • Number of events 1 • From Day 1 until 7 days after the last dose of study drug.
Gastrointestinal disorders abdominal pain	0.00% 0/84 • From Day 1 until 7 days after the last dose of study drug.	1.2% 1/83 • Number of events 1 • From Day 1 until 7 days after the last dose of study drug.	0.00% 0/83 • From Day 1 until 7 days after the last dose of study drug.	0.00% 0/83 • From Day 1 until 7 days after the last dose of study drug.
General disorders asthenia	1.2% 1/84 • Number of events 1 • From Day 1 until 7 days after the last dose of study drug.	0.00% 0/83 • From Day 1 until 7 days after the last dose of study drug.	1.2% 1/83 • Number of events 1 • From Day 1 until 7 days after the last dose of study drug.	0.00% 0/83 • From Day 1 until 7 days after the last dose of study drug.
General disorders fatigue	0.00% 0/84 • From Day 1 until 7 days after the last dose of study drug.	0.00% 0/83 • From Day 1 until 7 days after the last dose of study drug.	1.2% 1/83 • Number of events 1 • From Day 1 until 7 days after the last dose of study drug.	0.00% 0/83 • From Day 1 until 7 days after the last dose of study drug.

Additional Information

Thomas Dahl

Sequential Medicine Ltd

Phone: 617-818-2735

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place