A Study to Evaluate the Safety and Efficacy of NG101 in A... | NCT04303195

NCT04303195

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NG101 - 5 mg	Experimental	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks	Drug: NG101
NG101 - 10 mg	Experimental	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks	Drug: NG101
NG101 - 20 mg	Experimental	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks	Drug: NG101
Placebo	Placebo Comparator	Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
NG101	Drug	Capsules	NG101 - 10 mg NG101 - 20 mg NG101 - 5 mg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline of Nausea Severity Score	Change from Baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD). Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.	Baseline to Week 12

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Early Satiety Severity Score	Change from baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD) for early satiety severity score. Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Digestive Health Specialists		Dothan	Alabama	36305	United States
G & L Research, LLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40367443	Derived	Loesch J, Hamza E, Pasricha PJ, Nee J, Cline M, MacDougall J, Simons M, Brown JT, Garg S, Hoscheit M, Gabbard S, De Colle C, Lembo A. A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Metopimazine Mesylate (NG101) in Participants With Gastroparesis. Am J Gastroenterol. 2026 Feb 1;121(2):534-544. doi: 10.14309/ajg.0000000000003534. Epub 2025 May 14.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	NG101 - 5 mg	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
FG001	NG101 - 10 mg	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Nov 8, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

No data available

No data is available for this block.

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

metopimazine mesylate

This study included a Screening Period of up to 6 weeks and a 2-week Pretreatment Period. Following successful completion of the Pretreatment Period, participants eligible for the clinical study were randomized in a 1:1:1:1 ratio to receive either NG101 5 mg, 10 mg, or 20 mg, or matching placebo during a 12-week Treatment Period.

Arm/Group Information

ID	Title	Description
BG000	NG101 - 5 mg	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
BG001	NG101 - 10 mg	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
BG002	NG101 - 20 mg	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
BG003	Placebo	Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Categorical

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
<=18 years	BG0000 BG0010 BG0020 BG003

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00052.7± 11.5 BG00153.7± 11.26 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00033 BG00134 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00017 BG00120 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00040 BG00141 BG002

Gastroparesis etiology

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Diabetic	BG00018 BG00119 BG002

Cannabinoid use

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Yes	BG0004 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Baseline of Nausea Severity Score

Change from Baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD). Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.

Per Protocol population included all participants in the Intent-To-Treat Population (all enrolled participants who were randomized) who do not have any major protocol deviations that would affect efficacy as determined by the study team.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline to Week 12

ID	Title	Description
OG000	NG101 - 5 mg	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG001	NG101 - 10 mg	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG002	NG101 - 20 mg	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG003	Placebo	Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules

Units	Counts
Participants	OG00037 OG00133 OG00233 OG003

Title

Denominators

Categories

Title	Measurements
	OG000-3.55± 0.331 OG001-3.65± 0.0348 OG002-3.43± 0.348 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG003		ANOVA		0.1350	The threshold for statistical significance was p = 0.05.	Mean Difference (Final Values)	-0.72	Standard Error of the Mean	0.479	2-Sided	95	-1.67	0.23					Superiority
OG001 OG003		ANCOVA

Secondary

Change From Baseline in Early Satiety Severity Score

Change from baseline at Weeks 7 through 12 (average) as measured by the Diabetic and Idiopathic Gastroparesis Symptoms Daily Diary (DIGS-DD) for early satiety severity score.

Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period, a participant's score for that week was the mean of the daily scores for that week. A negative change from baseline indicates improvement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline to Week 12

ID	Title	Description
OG000	NG101 - 5 mg	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG001	NG101 - 10 mg	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG002	NG101 - 20 mg	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG003

Secondary

Change From Baseline in Postprandial Fullness Severity Score

Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score.

Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period. A negative change from baseline indicates improvement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline to Week 12

ID	Title	Description
OG000	NG101 - 5 mg	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG001	NG101 - 10 mg	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG002	NG101 - 20 mg	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG003	Placebo

Secondary

Change From Baseline in Abdominal Pain Severity Score

Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for postprandial fullness severity score.

Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week in the 2-week Pretreatment Period, the 12-week Treatment Period, and the 2-week Follow-up Period. A negative change from baseline indicates improvement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline to Week 12

ID	Title	Description
OG000	NG101 - 5 mg	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG001	NG101 - 10 mg	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG002	NG101 - 20 mg	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG003	Placebo

Secondary

Change From Baseline in Discrete Episodes of Vomiting

Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for the number of discrete episodes of vomiting.

Participants were asked to record the number of episodes of vomiting in the past 24 hours. Each episode counts as "1". A negative change from baseline indicates improvement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline to Week 12

ID	Title	Description
OG000	NG101 - 5 mg	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG001	NG101 - 10 mg	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG002	NG101 - 20 mg	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG003	Placebo	Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules

Secondary

Change From Baseline in 3-symptom Severity Score

Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for 3-symptom severity score.

Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week, the 3-symptom severity score is the average of the mean daily scores of nausea, early satiety, and postprandial fullness severity scores. A negative change from baseline indicates improvement.

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline to Week 12

ID	Title	Description
OG000	NG101 - 5 mg	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG001	NG101 - 10 mg	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG002	NG101 - 20 mg	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG003	Placebo

Secondary

Change From Baseline in 4-symptom Severity Score

Change from baseline at Weeks 7 through 12 (average) as measured by patient's daily diary entries during participation in the study for 4-symptom severity score.

Participants were asked to rate their symptoms at their worst in the past 24 hours using a 0 to 10-point numeric rating scale (NRS). A score of 0 indicates no symptoms and a score of 10 indicates the worst possible symptoms. For each week, the 4-symptom severity score is the average of the mean daily scores of nausea, early satiety, postprandial fullness, and abdominal pain severity scores. A negative change from baseline indicates improvement

Posted

Least Squares Mean

Standard Error

units on a scale

Baseline to Week 12

ID	Title	Description
OG000	NG101 - 5 mg	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG001	NG101 - 10 mg	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG002	NG101 - 20 mg	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules
OG003	Placebo

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	NG101 - 5 mg	NG101 5 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	40	1	40	15	40
EG001	NG101 - 10 mg	NG101 10 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	41	0	41	12	41
EG002	NG101 - 20 mg	NG101 20 mg, capsules, orally, QID (4 times a day) for up to 12 weeks NG101: Capsules	40	1	40	21	40
EG003	Placebo	Placebo-matching, capsules, orally, QID (4 times a day) for up to 12 weeks Placebo: Capsules	40	0	40	14	40

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment		EG0001 events1 affected40 at risk EG0010 events0 affected41 at risk EG0020 events0 affected40 at risk EG0030 events0 affected40 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 21.1	Systematic Assessment		EG0000 events0 affected40 at risk EG0010 events0 affected41 at risk EG0021 events1 affected40 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0021 affected40 at risk EG0030 affected40 at risk
Palpitations	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Postural orthostatic tachycardia syndrome	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0022 affected40 at risk EG003
Tachycrdia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Abdominal tenderness	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0023 affected40 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0022 affected40 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Dyspepsia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Impaired gastric emptying	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0021 affected40 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0024 affected40 at risk EG003
Asthenia	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0020 affected40 at risk EG003
Oedema peripheral	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Bronchitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
COVID-19	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected40 at risk EG0011 affected41 at risk EG0021 affected40 at risk EG003
Coronavirus infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0012 affected41 at risk EG0020 affected40 at risk EG003
Helicobacter infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Laryngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Otitis media	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0020 affected40 at risk EG003
Pharyngitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected41 at risk EG0020 affected40 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Pustle	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Sinusitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0022 affected40 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected40 at risk EG0013 affected41 at risk EG0023 affected40 at risk EG003
Arthropod bite	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0020 affected40 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0020 affected40 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Glycosylated haemoglobin increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Hepatic enzyme increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Transaminases increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0020 affected40 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Dizziness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Migraine	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0022 affected40 at risk EG003
Presyncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Sinus headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0020 affected40 at risk EG003
Somnolence	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Syncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Depression	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Diabetic nephropathy	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Ketonuria	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Breast cyst	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Breast mass	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Galactorrhoea	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0021 affected40 at risk EG003
Vaginal haemorrhage	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Hiccups	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0020 affected40 at risk EG003
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0021 affected40 at risk EG003
Psoriasis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Skin lesion	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0020 affected40 at risk EG003
Haematoma	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0010 affected41 at risk EG0021 affected40 at risk EG003
Hypertension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected40 at risk EG0011 affected41 at risk EG0020 affected40 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected40 at risk EG0011 affected41 at risk EG0020 affected40 at risk EG003

First MCP Posted Date