Study to Assess the Efficacy and Safety of VX-210 in Subj... | NCT02669849

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator		Drug: Placebo
VX-210	Experimental		Drug: VX-210

Name	Type	Description	Arm Group Labels	Other Names
VX-210	Drug		VX-210
Placebo

Measure	Description	Time Frame
Change in Upper Extremity Motor Score (UEMS)	UEMS focuses selectively on the hand and arm control most relevant to individuals with a cervical spinal cord injury. UEMS ranges from 0 to 50, where a higher score indicates a better movement of hand and arm.	From baseline at 6 months post-treatment

Measure	Description	Time Frame
Spinal Cord Independence Measure (SCIM) III Self-Care Subscore	SCIM self-care subscore measures self-care abilities (feeding, dressing, grooming, bathing), respiration and sphincter management and mobility. The score ranges from 0-20, where a higher score represents a better outcome.	At 6 months post-treatment

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Acute traumatic cervical SCI, motor level of C4, C5, C6, or C7 on each side:
- Screening UEMS score must be ≤16 points on each side.
- AIS A subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and T1 on at least 1 side.
- AIS B subjects with a C4 motor level on both sides must have at least 1 point of motor activity between C5 and C7 on at least 1 side.
American Spinal Injury Association Impairment Scale (AIS) grade A or AIS grade B.
Scheduled and planned to undergo a spinal decompression/stabilization surgery that commences within 72 hours after the initial injury.
Computed tomography (CT) scan or magnetic resonance imaging (MRI) is consistent with the subject's neurological deficit.

Exclusion Criteria:

Participation in any other clinical study for acute SCI without approval by the sponsor.
Inability to undergo decompression/stabilization surgery that commences within 72 hours after injury.
One or more upper extremity muscle groups untestable during screening ISNCSCI examination.
Acute SCI from gunshot or penetrating/stab wound; non-traumatic SCI (e.g., transverse myelitis, acute disc herniation); brachial plexus injury; complete spinal cord transection; or multifocal SCI.
Females who are breastfeeding or have a positive serum pregnancy test.
Body mass index (BMI) of ≥40 kg/m^2 at screening.
History of an adverse reaction to a fibrin sealant or its components.
Unconsciousness or other mental impairment that precludes reliable International Standards for the Neurological Classification of Spinal Cord Injury (ISNCSCI) examination.
Known immunodeficiency, including human immunodeficiency virus, or use of immunosuppressive or cancer chemotherapeutic drugs.
Any significant medical or psychiatric comorbidities that would significantly increase the risk of study enrollment and/or significantly interfere with study outcomes or assessments, in the judgment of the investigator.

Other protocol defined Inclusion/Exclusion criteria may apply.

ID	Title	Description
FG000	Placebo	Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
FG001	VX-210 3 mg

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Apr 14, 2017	Nov 26, 2019

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 in Upper Extremity Motor Score (UEMS)

UEMS focuses selectively on the hand and arm control most relevant to individuals with a cervical spinal cord injury. UEMS ranges from 0 to 50, where a higher score indicates a better movement of hand and arm.

The "Overall Number of Participants Analyzed" included all randomized subjects who received study drug. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure.

Posted

Mean

Standard Deviation

units on a scale

From baseline at 6 months post-treatment

ID	Title	Description
OG000	Placebo	Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
OG001	VX-210 9 mg	Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.

Units	Counts
Participants	OG00029 OG00132

Title

Denominators

Categories

Title	Measurements
	OG0008.90± 9.48 OG0018.69± 7.35

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 OG001		Mixed-effects model for repeated measure		0.7519		Least Squares (LS) Mean Difference	-0.69			2-Sided	95	-5.08	3.69					Superiority

Secondary

Spinal Cord Independence Measure (SCIM) III Self-Care Subscore

SCIM self-care subscore measures self-care abilities (feeding, dressing, grooming, bathing), respiration and sphincter management and mobility. The score ranges from 0-20, where a higher score represents a better outcome.

Posted

Mean

Standard Deviation

units on a scale

At 6 months post-treatment

ID	Title	Description
OG000	Placebo	Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
OG001	VX-210 9 mg	Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.

Units	Counts
Participants

Secondary

Capabilities of Upper Extremity Test (CUE-T) Score

CUE-T measures a participant's ability to perform specific functional movements/tasks with the arms and hands (for example: grasping a pencil, pushing or lifting a weight). CUE-T score ranges from 0-128, where a higher score indicates an improvement in participant's ability.

Posted

Mean

Standard Deviation

units on a scale

At 6 months post-treatment

ID	Title	Description
OG000	Placebo	Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
OG001	VX-210 9 mg	Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.

Units	Counts
Participants

Secondary

Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension Score

GRASSP measures participant's ability to perform specific functional tasks with the arms, hands, and fingers. GRASSP quantitative prehension score ranges from 0-60, where a higher score indicates a better performance.

Posted

Mean

Standard Deviation

units on a scale

At 6 months post-treatment

ID	Title	Description
OG000	Placebo	Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
OG001	VX-210 9 mg	Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.

Units	Counts
Participants

Secondary

Percentage of American Spinal Injury Association Impairment Scale (AIS) Grade Responders

AIS ranks impairment according to body-wide motor/sensory results: Grade A: Complete (no sensory or motor function is preserved in the sacral segments S4 to 5); Grade B: Sensory Incomplete (sensory but not motor function is preserved below the neurological level and includes the sacral segments S4 to 5); Grade C: Motor Incomplete (motor function is preserved at the most caudal sacral segments); Grade D: Motor Incomplete (motor incomplete status as defined above, with at least half or more of key muscle functions below the single neurological level of injury having a muscle grade >=3; Grade E: Normal (sensation and motor function as tested are graded as normal in all segments). An AIS responder was defined as a subject with improvement by ≥2 AIS grades (i.e., baseline AIS Grade A changed to Grade C, D, or E; baseline AIS Grade B changed to D or E at 6 months after treatment).

Posted

Number

percentage of participants

At 6 months post-treatment

ID	Title	Description
OG000	Placebo	Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
OG001	VX-210 9 mg

Secondary

Percentage of Motor Level Responders

The motor level score for the right or left side assesses contraction strength of 10 key muscles in the upper and lower extremities on each side of the body; each muscle receives a score from 0 (total paralysis) to 5 ([normal] active movement). A motor level responder was defined as a subject with improvement by ≥2 motor levels on either side of the body (i.e., baseline level C4 changed to C6, C7, C8 on the left; or baseline level C5 changed to C7, C8 on the right).

Posted

Number

percentage of participants

At 6 months post-treatment

ID	Title	Description
OG000	Placebo	Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
OG001	VX-210 9 mg	Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-210

Pharmacokinetic analysis set included all participants for which PK data was collected. As per the amended protocol, the 3 mg arm was no longer planned to be assessed for any primary or secondary outcome measure.

Posted

Median

Full Range

hours (h)

up to 53 hours post-treatment

ID	Title	Description
OG000	VX-210 9 mg	Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.

Units	Counts
Participants	OG00028

Secondary

Maximum Observed Plasma Concentration (Cmax) of VX-210

Posted

Geometric Mean

Geometric Coefficient of Variation

nanogram per milliliter (ng/mL)

up to 53 hours post-treatment

ID	Title	Description
OG000	VX-210 9 mg	Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.

Units	Counts
Participants	OG000

Secondary

Area Under Plasma Concentration Time Curve (AUC) of VX-210

Posted

Geometric Mean

Geometric Coefficient of Variation

h*ng/mL

up to 53 hours post-treatment

ID	Title	Description
OG000	VX-210 9 mg	Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.

Units	Counts
Participants	OG000

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Bradycardia	Cardiac disorders	Meddra 21.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Cardiac arrest	Cardiac disorders	Meddra 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Cardiac failure	Cardiac disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Sinus bradycardia	Cardiac disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Deafness neurosensory	Ear and labyrinth disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Rectal haemorrhage	Gastrointestinal disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Pyrexia	General disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Anaphylactic reaction	Immune system disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Acute sinusitis	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Cellulitis	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Clostridium difficile colitis	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Device related sepsis	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Empyema	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Haemophilus infection	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Infected skin ulcer	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Lower respiratory tract infection bacterial	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Osteomyelitis	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Pneumonia	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0004 affected29 at risk EG0013 affected6 at risk EG0024 affected32 at risk
Pneumonia staphylococcal	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Sepsis	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0003 affected29 at risk EG0010 affected6 at risk EG0024 affected32 at risk
Septic shock	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Staphylococcal bacteraemia	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Urinary tract infection	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0004 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Urosepsis	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Vaginal infection	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Viral infection	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Wound sepsis	Infections and infestations	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Autonomic dysreflexia	Injury, poisoning and procedural complications	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Seroma	Injury, poisoning and procedural complications	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Wound dehiscence	Injury, poisoning and procedural complications	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Loss of consciousness	Nervous system disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Seizure	Nervous system disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Spinal cord compression	Nervous system disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Syncope	Nervous system disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Delirium	Psychiatric disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Mental disorder	Psychiatric disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Calculus bladder	Renal and urinary disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Haematuria	Renal and urinary disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Renal failure	Renal and urinary disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Ureterolithiasis	Renal and urinary disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Acute respiratory distress syndrome	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0002 affected29 at risk EG0012 affected6 at risk EG0022 affected32 at risk
Atelectasis	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Bronchopleural fistula	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Chronic respiratory failure	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0002 affected29 at risk EG0012 affected6 at risk EG0021 affected32 at risk
Respiratory distress	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	Meddra 21.1	Systematic Assessment	EG0003 affected29 at risk EG0012 affected6 at risk EG0023 affected32 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	Meddra 21.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected6 at risk EG0023 affected32 at risk
Deep vein thrombosis	Vascular disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Hypotension	Vascular disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Neurogenic shock	Vascular disorders	Meddra 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Subclavian vein thrombosis	Vascular disorders	Meddra 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Anaemia	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0008 affected29 at risk EG0012 affected6 at risk EG0026 affected32 at risk
Hypercoagulation	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Thrombocytosis	Blood and lymphatic system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Bradycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0006 affected29 at risk EG0010 affected6 at risk EG0024 affected32 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Tinnitus	Ear and labyrinth disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Hypothyroidism	Endocrine disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Dry eye	Eye disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0022 affected32 at risk
Abdominal discomfort	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Anorectal discomfort	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Colitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Constipation	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected29 at risk EG0010 affected6 at risk EG0027 affected32 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0011 affected6 at risk EG0025 affected32 at risk
Dry mouth	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Dysphagia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0026 affected32 at risk
Flatulence	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Ileus	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected29 at risk EG0010 affected6 at risk EG0023 affected32 at risk
Melaena	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Nausea	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected29 at risk EG0013 affected6 at risk EG0025 affected32 at risk
Neurogenic bowel	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0010 affected6 at risk EG0024 affected32 at risk
Odynophagia	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Oral pain	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Vomiting	Gastrointestinal disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Chest pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Chills	General disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Generalised oedema	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0023 affected32 at risk
Impaired healing	General disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Oedema peripheral	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Pain	General disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Pyrexia	General disorders	MedDRA 21.1	Systematic Assessment	EG00013 affected29 at risk EG0013 affected6 at risk EG00216 affected32 at risk
Drug hypersensitivity	Immune system disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Clostridium difficile infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0022 affected32 at risk
Conjunctivitis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Fungal skin infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Infected skin ulcer	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Influenza	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Oral candidiasis	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected6 at risk EG0025 affected32 at risk
Pneumonia	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0007 affected29 at risk EG0012 affected6 at risk EG00211 affected32 at risk
Staphylococcal infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Urinary tract infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG00018 affected29 at risk EG0014 affected6 at risk EG00218 affected32 at risk
Vulvovaginal mycotic infection	Infections and infestations	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Autonomic dysreflexia	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0010 affected6 at risk EG0023 affected32 at risk
Limb injury	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Muscle rupture	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Procedural pain	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Weaning failure	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Wound	Injury, poisoning and procedural complications	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Aspartate aminotransferase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Blood creatine phosphokinase increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Blood magnesium decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Blood phosphorus decreased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Electrocardiogram abnormal	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Haemophilus test positive	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Hepatic enzyme increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
International normalised ratio increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Liver function test abnormal	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Neutrophil count increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Prothrombin time prolonged	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
White blood cell count increased	Investigations	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0012 affected6 at risk EG0020 affected32 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Fluid overload	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Hypercalcaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0022 affected32 at risk
Hypernatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected6 at risk EG0023 affected32 at risk
Hypoalbuminaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Hypocalcaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected29 at risk EG0010 affected6 at risk EG0025 affected32 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected6 at risk EG0025 affected32 at risk
Hypophosphataemia	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected29 at risk EG0010 affected6 at risk EG0023 affected32 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0009 affected29 at risk EG0013 affected6 at risk EG00214 affected32 at risk
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Musculoskeletal pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected29 at risk EG0011 affected6 at risk EG0025 affected32 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected29 at risk EG0010 affected6 at risk EG0024 affected32 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Pain in jaw	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Dizziness	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Head discomfort	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Headache	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0011 affected6 at risk EG0024 affected32 at risk
Muscle spasticity	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected6 at risk EG0024 affected32 at risk
Neuralgia	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected29 at risk EG0012 affected6 at risk EG00210 affected32 at risk
Nystagmus	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Syncope	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Unresponsive to stimuli	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Vocal cord paralysis	Nervous system disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Adjustment disorder	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Agitation	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Anxiety	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0006 affected29 at risk EG0011 affected6 at risk EG0029 affected32 at risk
Delirium	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Depression	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0007 affected29 at risk EG0011 affected6 at risk EG0026 affected32 at risk
Hallucination	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Insomnia	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG00011 affected29 at risk EG0012 affected6 at risk EG0029 affected32 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Neurogenic bladder	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected29 at risk EG0010 affected6 at risk EG0028 affected32 at risk
Urinary retention	Renal and urinary disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Vaginal discharge	Reproductive system and breast disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Apnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Bronchial secretion retention	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0006 affected29 at risk EG0010 affected6 at risk EG0023 affected32 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0010 affected6 at risk EG0022 affected32 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0022 affected32 at risk
Pneumothorax spontaneous	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Pulmonary haemorrhage	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Wheezing	Respiratory, thoracic and mediastinal disorders	MedDRA 21.1	Systematic Assessment	EG0001 affected29 at risk EG0011 affected6 at risk EG0021 affected32 at risk
Decubitus ulcer	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG00011 affected29 at risk EG0013 affected6 at risk EG00215 affected32 at risk
Dry skin	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0010 affected6 at risk EG0020 affected32 at risk
Hyperhidrosis	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0003 affected29 at risk EG0013 affected6 at risk EG0021 affected32 at risk
Rash	Skin and subcutaneous tissue disorders	MedDRA 21.1	Systematic Assessment	EG0004 affected29 at risk EG0010 affected6 at risk EG0023 affected32 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0005 affected29 at risk EG0010 affected6 at risk EG0021 affected32 at risk
Haematoma	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0020 affected32 at risk
Hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG00010 affected29 at risk EG0010 affected6 at risk EG00211 affected32 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0002 affected29 at risk EG0013 affected6 at risk EG0025 affected32 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 21.1	Systematic Assessment	EG0000 affected29 at risk EG0011 affected6 at risk EG0022 affected32 at risk

Facility	Status	City	State	ZIP	Country	Contacts
		Birmingham	Alabama		United States

ID	Title	Description
BG000	Placebo	Participants who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
BG001	VX-210 3 mg	Participants who received VX-210 3 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
BG002	VX-210 9 mg	Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
BG003	Total	Total of all reporting 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 who received placebo matched to VX-210 as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.	1	29	18	29	28	29
EG001	VX-210 3 mg	Participants who received VX-210 3 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.	1	6	6	6	6	6
EG002	VX-210 9 mg	Participants who received VX-210 9 mg as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.	2	32	16	32	32	32