Trial Outcomes & Findings for Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis (NCT NCT04024891)
NCT ID: NCT04024891
Last Updated: 2023-08-29
Results Overview
Change in pharmacologically-induced mydriatic (maximum) pupil diameter at 2 hours post-treatment in the study eye.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
32 participants
Primary outcome timeframe
2 hours
Results posted on
2023-08-29
Participant Flow
This is a crossover design study, so all 32 enrolled subjects were included in both treatment groups.
Participant milestones
| Measure |
PMOS 1% First, Then PMOS Vehicle
Participant received Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist at Visit 1. Then, after one week, they received Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.
1 drop in each eye, 1 hour post medically-induced mydriasis at both visits.
|
PMOS Vehicle First, Then PMOS 1%
Participants received Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 1. Then, after one week, they received Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist at Visit 2.
1 drop in each eye, 1 hour post medically-induced mydriasis for both visits.
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
16
|
|
Overall Study
COMPLETED
|
16
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
PMOS 1% First, Then PMOS Vehicle
Participant received Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist at Visit 1. Then, after one week, they received Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 2.
1 drop in each eye, 1 hour post medically-induced mydriasis at both visits.
|
PMOS Vehicle First, Then PMOS 1%
Participants received Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution at Visit 1. Then, after one week, they received Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist at Visit 2.
1 drop in each eye, 1 hour post medically-induced mydriasis for both visits.
|
|---|---|---|
|
Overall Study
Pregnancy
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
PMOS 1% First, Then PMOS Vehicle
n=16 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
PMOS Vehicle First, Then PMOS 1%
n=15 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
|
Total
n=31 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.6 years
STANDARD_DEVIATION 8.18 • n=16 Participants
|
28.5 years
STANDARD_DEVIATION 8.54 • n=15 Participants
|
28.0 years
STANDARD_DEVIATION 8.23 • n=31 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=16 Participants
|
10 Participants
n=15 Participants
|
19 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=16 Participants
|
5 Participants
n=15 Participants
|
12 Participants
n=31 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Iris Color
Brown
|
16 Participants
n=16 Participants
|
15 Participants
n=15 Participants
|
31 Participants
n=31 Participants
|
|
Iris Color
Non-Brown
|
0 Participants
n=16 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=31 Participants
|
|
Mydriatic Agent Recieved
Phenylephrine
|
8 Participants
n=16 Participants
|
7 Participants
n=15 Participants
|
15 Participants
n=31 Participants
|
|
Mydriatic Agent Recieved
Tropicamide
|
8 Participants
n=16 Participants
|
8 Participants
n=15 Participants
|
16 Participants
n=31 Participants
|
|
Baseline Pupil Diameter (Study Eye)
|
4.5 mm
STANDARD_DEVIATION 0.80 • n=16 Participants
|
4.5 mm
STANDARD_DEVIATION 0.79 • n=15 Participants
|
4.5 mm
STANDARD_DEVIATION 0.78 • n=31 Participants
|
|
Maximum Dilated Pupil Diameter (Study Eye)
|
7.3 mm
STANDARD_DEVIATION 1.04 • n=16 Participants
|
7.2 mm
STANDARD_DEVIATION 1.04 • n=15 Participants
|
7.3 mm
STANDARD_DEVIATION 1.02 • n=31 Participants
|
PRIMARY outcome
Timeframe: 2 hoursPopulation: Crossover design study
Change in pharmacologically-induced mydriatic (maximum) pupil diameter at 2 hours post-treatment in the study eye.
Outcome measures
| Measure |
Phentolamine Mesylate Ophthalmic Solution 1%
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Mesylate Ophthalmic Solution Vehicle
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
|
|---|---|---|
|
Pupil Diameter (Change From Max)
|
-1.69 mm
Standard Error 0.117
|
-0.69 mm
Standard Error 0.117
|
SECONDARY outcome
Timeframe: 30 min, 1 hours, 4 hours, 6 hoursPopulation: Crossover design trial
Change in pharmacologically-induced mydriatic (maximum) pupil diameter at remaining timepoints (30 min, 1 hours, 4 hours, 6 hours)
Outcome measures
| Measure |
Phentolamine Mesylate Ophthalmic Solution 1%
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Mesylate Ophthalmic Solution Vehicle
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
|
|---|---|---|
|
Pupil Diameter (Change From Max)
30 minutes
|
-0.06 mm
Standard Error 0.039
|
-0.13 mm
Standard Error 0.039
|
|
Pupil Diameter (Change From Max)
1 hour
|
-0.77 mm
Standard Error 0.072
|
-0.29 mm
Standard Error 0.072
|
|
Pupil Diameter (Change From Max)
4 hours
|
-2.83 mm
Standard Error 0.145
|
-1.69 mm
Standard Error 0.146
|
|
Pupil Diameter (Change From Max)
6 hours
|
-3.24 mm
Standard Error 0.132
|
-2.54 mm
Standard Error 0.133
|
SECONDARY outcome
Timeframe: 0 min, 1 hour, 2 hours, 4 hours, 6 hoursPercent of Subjects Achieving Pupil Diameter No More Than 0.5 mm Above Baseline by Time Point with either phenylephrine or tropicamide
Outcome measures
| Measure |
Phentolamine Mesylate Ophthalmic Solution 1%
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Mesylate Ophthalmic Solution Vehicle
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
|
|---|---|---|
|
Pupil Diameter Return to Baseline
0 min
|
2 Participants
|
3 Participants
|
|
Pupil Diameter Return to Baseline
1 hour
|
6 Participants
|
3 Participants
|
|
Pupil Diameter Return to Baseline
2 hour
|
11 Participants
|
6 Participants
|
|
Pupil Diameter Return to Baseline
4 hour
|
24 Participants
|
12 Participants
|
|
Pupil Diameter Return to Baseline
6 hour
|
31 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 0 min, 2 hours, 4 hoursPopulation: Crossover Design Trial
Change from baseline (-1 hour) in accommodation at each time point (0 min, 2 hours, 4 hours) with Tropicamide and Phenylephrine Worsening of accommodation is defined as an amplitude decrease of greater than 1 diopter compared to baseline
Outcome measures
| Measure |
Phentolamine Mesylate Ophthalmic Solution 1%
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Mesylate Ophthalmic Solution Vehicle
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
|
|---|---|---|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Tropicamide, 4 hr · Changed Accommodation (≥1 D)
|
5 Participants
|
9 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Phenylephrine, 0 min · Unchanged Accommodation
|
10 Participants
|
11 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Phenylephrine, 0 min · Changed Accommodation (≥1 D)
|
5 Participants
|
4 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Phenylephrine, 2 hr · Unchanged Accommodation
|
11 Participants
|
13 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Phenylephrine, 2 hr · Changed Accommodation (≥1 D)
|
4 Participants
|
2 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Phenylephrine, 4 hr · Unchanged Accommodation
|
12 Participants
|
13 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Phenylephrine, 4 hr · Changed Accommodation (≥1 D)
|
3 Participants
|
2 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Tropicamide, 0 min · Unchanged Accommodation
|
3 Participants
|
2 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Tropicamide, 0 min · Changed Accommodation (≥1 D)
|
13 Participants
|
14 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Tropicamide, 2 hr · Unchanged Accommodation
|
7 Participants
|
3 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Tropicamide, 2 hr · Changed Accommodation (≥1 D)
|
9 Participants
|
13 Participants
|
|
Accommodation Measured by the Near Point Rule (Diopters) (Change From Baseline), Percent With Unchanged Accommodation
Dilated with Tropicamide, 4 hr · Unchanged Accommodation
|
11 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hoursPopulation: All randomized participants who recieved the medication.
Conjunctival hyperemia at each timepoint (0 min, 30 min, 1 hour, 2 hours, 4 hours, 6 hours), for study eye; in all subjects. Scale 0-3 (None, Mild, Moderate, Severe)
Outcome measures
| Measure |
Phentolamine Mesylate Ophthalmic Solution 1%
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Mesylate Ophthalmic Solution Vehicle
n=32 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
|
|---|---|---|
|
Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)
1 hr
|
1.55 score on a scale (0-3)
Standard Deviation 0.675
|
0.45 score on a scale (0-3)
Standard Deviation 0.568
|
|
Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)
2 hr
|
1.42 score on a scale (0-3)
Standard Deviation 0.620
|
0.45 score on a scale (0-3)
Standard Deviation 0.568
|
|
Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)
4 hr
|
1.10 score on a scale (0-3)
Standard Deviation 0.539
|
0.42 score on a scale (0-3)
Standard Deviation 0.564
|
|
Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)
6 hr
|
0.81 score on a scale (0-3)
Standard Deviation 0.654
|
0.35 score on a scale (0-3)
Standard Deviation 0.486
|
|
Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)
Baseline (-1 hr)
|
0.45 score on a scale (0-3)
Standard Deviation 0.568
|
0.35 score on a scale (0-3)
Standard Deviation 0.486
|
|
Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)
0 min
|
0.23 score on a scale (0-3)
Standard Deviation 0.497
|
0.29 score on a scale (0-3)
Standard Deviation 0.461
|
|
Conjunctival Hyperemia (Eye Redness) Assessed Visually With the Brien Holden Vision Institute (Formerly Corneal and Contact Lens Research Unit, or CCLRU) Bulbar Redness Scale (0-3)
30 min
|
1.52 score on a scale (0-3)
Standard Deviation 0.677
|
0.42 score on a scale (0-3)
Standard Deviation 0.502
|
SECONDARY outcome
Timeframe: 0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hoursChange from baseline (-1 hour) in Best Corrected Distance Visual Acuity at each time point (0 min, 30 mins, 1 hour, 2 hours, 6 hours) in Study Eye
Outcome measures
| Measure |
Phentolamine Mesylate Ophthalmic Solution 1%
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Mesylate Ophthalmic Solution Vehicle
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
|
|---|---|---|
|
Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)
0 mins
|
-0.45 Letters Read
Standard Error 2.142
|
-0.81 Letters Read
Standard Error 2.182
|
|
Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)
1 hour
|
0.29 Letters Read
Standard Error 1.774
|
-0.10 Letters Read
Standard Error 2.797
|
|
Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)
2 hours
|
0.65 Letters Read
Standard Error 2.727
|
0.16 Letters Read
Standard Error 2.162
|
|
Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)
4 hours
|
1.06 Letters Read
Standard Error 2.205
|
0.10 Letters Read
Standard Error 2.119
|
|
Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)
30 mins
|
-0.55 Letters Read
Standard Error 2.188
|
-0.55 Letters Read
Standard Error 1.690
|
|
Best Corrected Distance Visual Acuity (BCDVA) Measured by Early Treatment Diabetic Retinopathy Study (ETDRS) Light Box Chart (Letters) at 4 Meters (Change From Baseline)
6 hours
|
0.45 Letters Read
Standard Error 3.982
|
0.90 Letters Read
Standard Error 2.399
|
SECONDARY outcome
Timeframe: 0 mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hoursChange from baseline (-1 hour) in Distance Corrected Near Visual Acuity at each time point (0 min, 30 mins, 1 hour, 2 hours, 6 hours) in Study Eye
Outcome measures
| Measure |
Phentolamine Mesylate Ophthalmic Solution 1%
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Mesylate Ophthalmic Solution Vehicle
n=31 Participants
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
|
|---|---|---|
|
Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change From Baseline)
1 hour
|
0.05 LogMar
Standard Deviation 0.146
|
0.07 LogMar
Standard Deviation 0.142
|
|
Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change From Baseline)
2 hours
|
0.03 LogMar
Standard Deviation 0.113
|
0.00 LogMar
Standard Deviation 0.087
|
|
Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change From Baseline)
4 hours
|
0.00 LogMar
Standard Deviation 0.075
|
0.01 LogMar
Standard Deviation 0.079
|
|
Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change From Baseline)
6 hours
|
-0.02 LogMar
Standard Deviation 0.083
|
0.00 LogMar
Standard Deviation 0.055
|
|
Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change From Baseline)
0 mins
|
0.14 LogMar
Standard Deviation 0.194
|
0.13 LogMar
Standard Deviation 0.216
|
|
Distance-Corrected Near Visual Acuity (DCNVA) Measured by Standard Reading Card (Original Series Sloan Letter ETDRS Card at 16 Inches, LogMAR Units) (Change From Baseline)
30 mins
|
0.09 LogMar
Standard Deviation 0.156
|
0.09 LogMar
Standard Deviation 0.217
|
Adverse Events
Phentolamine Mesylate Ophthalmic Solution 1%
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Phentolamine Mesylate Ophthalmic Solution Vehicle
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Phentolamine Mesylate Ophthalmic Solution 1%
n=31 participants at risk
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution 1%: 1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
|
Phentolamine Mesylate Ophthalmic Solution Vehicle
n=32 participants at risk
1 drop in each eye, 1 hour post medically-induced mydriasis
Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo): Topical Sterile Ophthalmic Solution
|
|---|---|---|
|
Eye disorders
Conjunctival Hyperemia
|
35.5%
11/31 • 2 weeks.
All AEs/adverse reactions occurring during the study (ie, once the subject had signed the informed consent) were documented on the CRF, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.
|
0.00%
0/32 • 2 weeks.
All AEs/adverse reactions occurring during the study (ie, once the subject had signed the informed consent) were documented on the CRF, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.
|
|
Gastrointestinal disorders
Abdominal Pain, Upper
|
0.00%
0/31 • 2 weeks.
All AEs/adverse reactions occurring during the study (ie, once the subject had signed the informed consent) were documented on the CRF, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.
|
3.1%
1/32 • 2 weeks.
All AEs/adverse reactions occurring during the study (ie, once the subject had signed the informed consent) were documented on the CRF, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/31 • 2 weeks.
All AEs/adverse reactions occurring during the study (ie, once the subject had signed the informed consent) were documented on the CRF, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.
|
3.1%
1/32 • 2 weeks.
All AEs/adverse reactions occurring during the study (ie, once the subject had signed the informed consent) were documented on the CRF, regardless of the assumption of causal relationship. All TEAEs/adverse reactions were documented from the time the subject received the first dose of study medication until the subject's participation in the study had completed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place