Clinical Study to Investigate the Efficacy and Safety of... | NCT02091739

NCT02091739

ID	Type	Description	Link
2012-005539-10	EudraCT Number

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
IncobotulinumtoxinA (Xeomin) (100 Units)	Experimental	Main period (1 treatment cycle): Subjects to receive 100 Units. Extension period (3 treatment cycles): Subjects to receive 100 Units per treatment cycle. Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)	Drug: IncobotulinumtoxinA (100 Units)
IncobotulinumtoxinA (Xeomin) (75 Units)	Experimental	Main period (1 treatment cycle): Subjects to receive 75 Units. Extension period (3 treatment cycles): Subjects to receive 75 Units per treatment cycle. Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)	Drug: IncobotulinumtoxinA (75 Units)
Placebo	Placebo Comparator	Main period (1 treatment cycle): Subjects to receive placebo injection. Extension period (3 treatment cycles): Subjects will be randomized to receive either 75 or 100 Units IncobotulinumtoxinA per treatment cycle. Mode of administration: Four injections per treatment cycle (parotid and submandibular glands, bilateral)	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
IncobotulinumtoxinA (100 Units)	Drug	Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4	uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.	Baseline and Week 4
MP: Participant's Global Impression of Change Scale (GICS) at Week 4	The GICS was used to measure the impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.	Week 4

Secondary Outcomes

Measure	Description	Time Frame
MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12	uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.	Baseline, Week 8 and 12
MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Merz Medical Expert	Merz Pharmaceuticals GmbH	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Merz investigational site #049172		Bonn		53105	Germany
Merz Investigational Site #049335

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31794936	Derived	Jost WH, Friedman A, Michel O, Oehlwein C, Slawek J, Bogucki A, Ochudlo S, Banach M, Pagan F, Flatau-Baque B, Dorsch U, Csikos J, Blitzer A. Long-term incobotulinumtoxinA treatment for chronic sialorrhea: Efficacy and safety over 64 weeks. Parkinsonism Relat Disord. 2020 Jan;70:23-30. doi: 10.1016/j.parkreldis.2019.11.024. Epub 2019 Nov 26.
30918101

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	Placebo	Participants received one injection session of overall 2.0 milliliter (mL) placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
FG001	MP: IncobotulinumtoxinA (Xeomin) (75 Units)

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

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

IncobotulinumtoxinA (Xeomin) (100 Units)

The Full analysis set (FAS) is the subset of participants who were treated and had at least the baseline value of unstimulated salivary flow (uSFR).

Arm/Group Information

ID	Title	Description
BG000	MP: Placebo	Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
BG001	MP: IncobotulinumtoxinA (Xeomin) (75 Units)	Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
BG002	MP: IncobotulinumtoxinA (Xeomin) (100 Units)	Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
BG003	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

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG00124 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0000 BG0010 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0000 BG0010 BG002

Weight

Mean

Standard Deviation

kilogram (kg)

Title

Denominators

Categories

Title	Measurements
	BG00080.6± 16.4 BG00178.4± 17.1 BG002

Body Mass Index (BMI)

Mean

Standard Deviation

kilogram per square meter (kg/m^2)

Title

Denominators

Categories

Title	Measurements
	BG00028.5± 6 BG00126.7± 5.2 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

MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 4

uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.

Analysis covers all participants from FAS who have at least one post-baseline uSFR assessment. The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.

Posted

Least Squares Mean

Standard Error

gram per minute (g/min)

Baseline and Week 4

ID	Title	Description
OG000	MP: Placebo	Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
OG001	MP: IncobotulinumtoxinA (Xeomin) (75 Units)	Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
OG002	MP: IncobotulinumtoxinA (Xeomin) (100 Units)	Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.

Units	Counts
Participants	OG00036 OG00173 OG00273

Title

Denominators

Categories

Title	Measurements
	OG000-0.04± 0.033 OG001-0.06± 0.027 OG002-0.13± 0.026

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 OG002	A fixed sequence test procedure was used for the confirmatory analysis of the co-primary endpoints by comparing the least square (LS) means estimates of an mixed model repeated measurement (MMRM) model (2-sided, significance level alpha=0.05) between treatment groups in the following order: IncobotulinumtoxinA 100 units versus (v) Placebo IncobotulinumtoxinA 75 units v Placebo	MMRM		= 0.004		LS mean difference	-0.09	Standard Error of the Mean	0.031	2-Sided	95	-0.15	0.03					Superiority

Primary

MP: Participant's Global Impression of Change Scale (GICS) at Week 4

The GICS was used to measure the impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.

The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 4

ID	Title	Description
OG000	MP: Placebo	Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
OG001	MP: IncobotulinumtoxinA (Xeomin) (75 Units)	Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
OG002	MP: IncobotulinumtoxinA (Xeomin) (100 Units)

Secondary

MP: Change From Baseline in Unstimulated Salivary Flow (uSFR) Rate at Week 8 and 12

uSFR was assessed by weighing of dental rolls soaked with saliva over 5 minutes and then procedure was repeated after 30 minutes and the average of the 2 results for flow rate was calculated.

Analysis covers all participants from FAS who have at least one post-baseline uSFR assessment. The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.

Posted

Least Squares Mean

Standard Error

g/min

Baseline, Week 8 and 12

ID	Title	Description
OG000	MP: Placebo	Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
OG001	MP: IncobotulinumtoxinA (Xeomin) (75 Units)	Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
OG002	MP: IncobotulinumtoxinA (Xeomin) (100 Units)	Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.

Secondary

MP: Global Impression of Change Scale (GICS) at Week 1, 2, 8 and 12

The GICS was used to measure the investigator's impression of change due to treatment. The response option was a common 7-point Likert scale that ranged from -3 = very much worse to +3 = very much improved and was applicable for participant and caregiver. If the participant was not able to answer then carer's rating was to be recorded instead of participant's rating and the participant's rating was left blank.

The FAS is the subset of participants who were treated and had at least the baseline value of uSFR.

Posted

Least Squares Mean

Standard Error

units on a scale

Week 1, 2, 8, and 12

ID	Title	Description
OG000	MP: Placebo	Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
OG001	MP: IncobotulinumtoxinA (Xeomin) (75 Units)	Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.
OG002	MP: IncobotulinumtoxinA (Xeomin) (100 Units)

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Placebo	Participants received one injection session of overall 2.0 mL placebo matched to the volume of incobotulinumtoxinA via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.	0	36	3	36	2	36
EG001	MP: IncobotulinumtoxinA (Xeomin) (75 Units)	Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.	0	74	6	74	14	74
EG002	MP: IncobotulinumtoxinA (Xeomin) (100 Units)	Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.	0	74	9	74	10	74
EG003	EP: IncobotulinumtoxinA (Xeomin) (75 Units)	Participants received overall 2.0 mL incobotulinumtoxinA containing 75 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.	3	82	15	82	22	82
EG004	EP: IncobotulinumtoxinA (Xeomin) (100 Units)	Participants received overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands at each of the three injection sessions in the EP.	2	89	14	89	22	89

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Orthostatic hypotension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG0030 events0 affected82 at risk EG0040 events0 affected89 at risk
Hypertensive crisis	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Medical device battery replacement	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected74 at risk EG003
Medical device change	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected74 at risk EG003
Rehabilitation therapy	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected74 at risk EG003
Angioplasty	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Appendicectomy	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Enterostomy	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Explorative laparotomy	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Laparotomy	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Nephrectomy	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Renal stone removal	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Ureter dilation procedure	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Ureteral stent insertion	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Chest pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected74 at risk EG003
General physical health deterioration	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Pain	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Pyrexia	General disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Hallucination	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Delusion	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Depression	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Dopamine dysregulation syndrome	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Suicidal ideation	Psychiatric disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Femur fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected74 at risk EG003
Rib fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Chest injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Head injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Skin abrasion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Angiogram	Investigations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Cardiac failure	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Aortic valve stenosis	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Bradycardia	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Cardio-respiratory arrest	Cardiac disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Coagulopathy	Blood and lymphatic system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Lower respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Parkinson's disease	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0021 events1 affected74 at risk EG003
Drop attacks	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected74 at risk EG003
Freezing phenomenon	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected74 at risk EG003
Akinesia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Altered state of consciousness	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Dementia	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Movement disorder	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Orthostatic intolerance	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Presyncope	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Psychomotor hyperactivity	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Speech disorder	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Cardiac pacemaker insertion	Nervous system disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected74 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Gastrointestinal obstruction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected74 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Volvulus	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Dysphagia	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Faecal vomiting	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Gastric ulcer haemorrhage	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Giant cell epulis	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Megacolon	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Oesophageal food impaction	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Urethral stenosis	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Extravasation of urine	Renal and urinary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Drug-induced liver injury	Hepatobiliary disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Device occlusion	Product Issues	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0021 events1 affected74 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Pneumonia	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0011 events1 affected74 at risk EG0020 events0 affected74 at risk EG003
Pyuria	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Acute sinusitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Cellulitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0020 events0 affected74 at risk EG003

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hypertension	Vascular disorders	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected36 at risk EG0012 events2 affected74 at risk EG0023 events3 affected74 at risk EG0035 events5 affected82 at risk EG0042 events2 affected89 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0018 events6 affected74 at risk EG0025 events2 affected74 at risk EG003
Contusion	Injury, poisoning and procedural complications	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0015 events4 affected74 at risk EG0020 events0 affected74 at risk EG003
Tooth extraction	Surgical and medical procedures	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0010 events0 affected74 at risk EG0024 events4 affected74 at risk EG003
Dry mouth	Gastrointestinal disorders	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0015 events4 affected74 at risk EG0023 events3 affected74 at risk EG003
Nasopharyngitis	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0001 events1 affected36 at risk EG0012 events2 affected74 at risk EG0022 events2 affected74 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA 19.1	Systematic Assessment	EG0000 events0 affected36 at risk EG0012 events2 affected74 at risk EG0020 events0 affected74 at risk EG003

ID	Term
D010300	Parkinson Disease
D000070642	Brain Injuries, Traumatic

Ancestor Terms

ID	Term
D020734	Parkinsonian Disorders
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D009069	Movement Disorders
D000080874	Synucleinopathies
D019636	Neurodegenerative Diseases
D001930	Brain Injuries
D006259	Craniocerebral Trauma
D020196	Trauma, Nervous System
D014947	Wounds and Injuries

ID	Term
C545476	incobotulinumtoxinA
D019274	Botulinum Toxins, Type A

Ancestor Terms

ID	Term
D001905	Botulinum Toxins
D008666	Metalloendopeptidases
D010450	Endopeptidases
D010447	Peptide Hydrolases
D006867	Hydrolases
D004798	Enzymes
D045762	Enzymes and Coenzymes
D045726	Metalloproteases
D001426	Bacterial Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D001427	Bacterial Toxins
D014118	Toxins, Biological
D001685	Biological Factors

Participants received one injection session of overall 2.0 mL incobotulinumtoxinA containing 100 units via bilateral intraglandular injection into the parotid and submandibular glands on Day 1 in the MP.