Trial Outcomes & Findings for Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury (NCT NCT02669849)
NCT ID: NCT02669849
Last Updated: 2020-01-22
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2/PHASE3
Target enrollment
70 participants
Primary outcome timeframe
From baseline at 6 months post-treatment
Results posted on
2020-01-22
Participant Flow
Participants were randomized to receive a single 9-mg dose of VX-210 or a placebo (buffer solution). A single 3-mg dose of VX-210 in fibrin sealant was initially included but was subsequently removed during the study through a protocol amendment. The 3-mg arm was not analyzed for primary and secondary efficacy and pharmacokinetic analysis.
A total of 70 participants were randomized, out of which 67 participants received the study drug.
Participant milestones
| Measure |
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.
|
VX-210 3 mg
Participants who received VX-210 3 milligram (mg) as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
29
|
6
|
32
|
|
Overall Study
COMPLETED
|
11
|
4
|
8
|
|
Overall Study
NOT COMPLETED
|
18
|
2
|
24
|
Reasons for withdrawal
| Measure |
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.
|
VX-210 3 mg
Participants who received VX-210 3 milligram (mg) as a single dose in fibrin sealant topically to the dural surface of the spinal cord within 72 hours after the initial injury.
|
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.
|
|---|---|---|---|
|
Overall Study
Withdrawal of Consent (not due to AE)
|
0
|
0
|
3
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
3
|
|
Overall Study
Death
|
1
|
1
|
2
|
|
Overall Study
Study terminated by sponsor
|
16
|
1
|
14
|
|
Overall Study
Other
|
0
|
0
|
2
|
Baseline Characteristics
Study to Assess the Efficacy and Safety of VX-210 in Subjects With Acute Traumatic Cervical Spinal Cord Injury
Baseline characteristics by cohort
| Measure |
Placebo
n=29 Participants
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.
|
VX-210 3 mg
n=6 Participants
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.
|
VX-210 9 mg
n=32 Participants
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.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.8 years
STANDARD_DEVIATION 17.4 • n=5 Participants
|
39.5 years
STANDARD_DEVIATION 24.4 • n=7 Participants
|
43.4 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
43.2 years
STANDARD_DEVIATION 17.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
51 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
43 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Upper Extremity Motor Score (UEMS)
|
13.00 units on a scale
STANDARD_DEVIATION 8.96 • n=5 Participants
|
10.17 units on a scale
STANDARD_DEVIATION 6.59 • n=7 Participants
|
14.03 units on a scale
STANDARD_DEVIATION 8.33 • n=5 Participants
|
13.24 units on a scale
STANDARD_DEVIATION 8.43 • n=4 Participants
|
PRIMARY outcome
Timeframe: From baseline at 6 months post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
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.
|
VX-210 9 mg
n=32 Participants
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.
|
|---|---|---|
|
Change in Upper Extremity Motor Score (UEMS)
|
8.90 units on a scale
Standard Deviation 9.48
|
8.69 units on a scale
Standard Deviation 7.35
|
SECONDARY outcome
Timeframe: At 6 months post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
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.
|
VX-210 9 mg
n=32 Participants
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.
|
|---|---|---|
|
Spinal Cord Independence Measure (SCIM) III Self-Care Subscore
|
6.2 units on a scale
Standard Deviation 7.0
|
5.9 units on a scale
Standard Deviation 6.6
|
SECONDARY outcome
Timeframe: At 6 months post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
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.
|
VX-210 9 mg
n=32 Participants
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.
|
|---|---|---|
|
Capabilities of Upper Extremity Test (CUE-T) Score
|
39.6 units on a scale
Standard Deviation 38.4
|
42.8 units on a scale
Standard Deviation 41.1
|
SECONDARY outcome
Timeframe: At 6 months post-treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Placebo
n=29 Participants
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.
|
VX-210 9 mg
n=32 Participants
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.
|
|---|---|---|
|
Graded Redefined Assessment of Strength, Sensibility and Prehension (GRASSP) Quantitative Prehension Score
|
18.9 units on a scale
Standard Deviation 19.4
|
20.1 units on a scale
Standard Deviation 21.6
|
SECONDARY outcome
Timeframe: At 6 months post-treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Placebo
n=29 Participants
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.
|
VX-210 9 mg
n=32 Participants
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.
|
|---|---|---|
|
Percentage of American Spinal Injury Association Impairment Scale (AIS) Grade Responders
|
30.0 percentage of participants
|
26.7 percentage of participants
|
SECONDARY outcome
Timeframe: At 6 months post-treatmentPopulation: 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.
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).
Outcome measures
| Measure |
Placebo
n=29 Participants
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.
|
VX-210 9 mg
n=32 Participants
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.
|
|---|---|---|
|
Percentage of Motor Level Responders
|
35.0 percentage of participants
|
33.3 percentage of participants
|
SECONDARY outcome
Timeframe: up to 53 hours post-treatmentPopulation: 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.
Outcome measures
| Measure |
Placebo
n=28 Participants
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.
|
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.
|
|---|---|---|
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of VX-210
|
4.59 hours (h)
Interval 2.58 to 52.38
|
—
|
SECONDARY outcome
Timeframe: up to 53 hours post-treatmentPopulation: 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.
Outcome measures
| Measure |
Placebo
n=28 Participants
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.
|
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.
|
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of VX-210
|
2.856 nanogram per milliliter (ng/mL)
Geometric Coefficient of Variation 200.35
|
—
|
SECONDARY outcome
Timeframe: up to 53 hours post-treatmentPopulation: 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.
Outcome measures
| Measure |
Placebo
n=28 Participants
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.
|
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.
|
|---|---|---|
|
Area Under Plasma Concentration Time Curve (AUC) of VX-210
|
44.683 h*ng/mL
Geometric Coefficient of Variation 284.95
|
—
|
Adverse Events
Placebo
Serious events: 18 serious events
Other events: 28 other events
Deaths: 1 deaths
VX-210 3 mg
Serious events: 6 serious events
Other events: 6 other events
Deaths: 1 deaths
VX-210 9 mg
Serious events: 16 serious events
Other events: 32 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Placebo
n=29 participants at risk
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.
|
VX-210 3 mg
n=6 participants at risk
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.
|
VX-210 9 mg
n=32 participants at risk
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.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Cardiac disorders
Bradycardia
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Cardiac disorders
Cardiac arrest
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Cardiac disorders
Cardiac failure
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Cardiac disorders
Sinus bradycardia
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
General disorders
Pyrexia
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Immune system disorders
Anaphylactic reaction
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Acute sinusitis
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Cellulitis
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Empyema
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Haemophilus infection
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Infected skin ulcer
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Lower respiratory tract infection bacterial
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Osteomyelitis
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Pneumonia
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
50.0%
3/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
12.5%
4/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Sepsis
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
12.5%
4/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Septic shock
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Urinary tract infection
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Vaginal infection
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Viral infection
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Wound sepsis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Autonomic dysreflexia
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Pneumothorax traumatic
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Seroma
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Wound dehiscence
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Seizure
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Psychiatric disorders
Delirium
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Psychiatric disorders
Mental disorder
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Renal and urinary disorders
Haematuria
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
33.3%
2/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic respiratory failure
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
33.3%
2/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
33.3%
2/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
9.4%
3/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
9.4%
3/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Vascular disorders
Deep vein thrombosis
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Vascular disorders
Hypotension
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Vascular disorders
Neurogenic shock
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Vascular disorders
Subclavian vein thrombosis
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
Other adverse events
| Measure |
Placebo
n=29 participants at risk
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.
|
VX-210 3 mg
n=6 participants at risk
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.
|
VX-210 9 mg
n=32 participants at risk
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.
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
21.9%
7/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
15.6%
5/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Blood and lymphatic system disorders
Anaemia
|
27.6%
8/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
33.3%
2/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
18.8%
6/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Blood and lymphatic system disorders
Hypercoagulation
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Cardiac disorders
Bradycardia
|
20.7%
6/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
12.5%
4/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Cardiac disorders
Tachycardia
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Eye disorders
Dry eye
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Colitis
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Dry mouth
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Dysphagia
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
18.8%
6/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Ileus
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
9.4%
3/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Melaena
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Nausea
|
24.1%
7/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
50.0%
3/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
15.6%
5/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Neurogenic bowel
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
12.5%
4/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Gastrointestinal disorders
Vomiting
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
General disorders
Chest pain
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
General disorders
Chills
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
General disorders
Generalised oedema
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
9.4%
3/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
General disorders
Impaired healing
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
General disorders
Oedema peripheral
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
General disorders
Pain
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
General disorders
Pyrexia
|
44.8%
13/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
50.0%
3/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
50.0%
16/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Immune system disorders
Drug hypersensitivity
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Fungal skin infection
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Infected skin ulcer
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Influenza
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Oral candidiasis
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
15.6%
5/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Pneumonia
|
24.1%
7/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
33.3%
2/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
34.4%
11/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Urinary tract infection
|
62.1%
18/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
66.7%
4/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
56.2%
18/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Autonomic dysreflexia
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
9.4%
3/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Limb injury
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Postoperative respiratory failure
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Weaning failure
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
Aspartate aminotransferase increased
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
Blood magnesium decreased
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
Blood phosphorus decreased
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
Electrocardiogram abnormal
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
Haemophilus test positive
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
Hepatic enzyme increased
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Investigations
White blood cell count increased
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
33.3%
2/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Fluid overload
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
9.4%
3/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
15.6%
5/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
15.6%
5/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Metabolism and nutrition disorders
Malnutrition
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
9.4%
3/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
31.0%
9/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
50.0%
3/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
43.8%
14/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
17.2%
5/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
15.6%
5/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
12.5%
4/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Headache
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
12.5%
4/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Muscle spasticity
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
12.5%
4/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Neuralgia
|
24.1%
7/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
33.3%
2/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
31.2%
10/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Nystagmus
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Syncope
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Unresponsive to stimuli
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Psychiatric disorders
Adjustment disorder
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Psychiatric disorders
Agitation
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Psychiatric disorders
Anxiety
|
20.7%
6/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
28.1%
9/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Psychiatric disorders
Delirium
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Psychiatric disorders
Depression
|
24.1%
7/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
18.8%
6/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Psychiatric disorders
Hallucination
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Psychiatric disorders
Insomnia
|
37.9%
11/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
33.3%
2/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
28.1%
9/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Renal and urinary disorders
Acute kidney injury
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Renal and urinary disorders
Neurogenic bladder
|
17.2%
5/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
25.0%
8/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Renal and urinary disorders
Urinary retention
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Apnoea
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial secretion retention
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
20.7%
6/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
9.4%
3/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
3.4%
1/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
37.9%
11/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
50.0%
3/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
46.9%
15/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.3%
3/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
50.0%
3/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.8%
4/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
9.4%
3/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Vascular disorders
Deep vein thrombosis
|
17.2%
5/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
3.1%
1/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Vascular disorders
Haematoma
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Vascular disorders
Hypotension
|
34.5%
10/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
0.00%
0/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
34.4%
11/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Vascular disorders
Orthostatic hypotension
|
6.9%
2/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
50.0%
3/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
15.6%
5/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/29 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
16.7%
1/6 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
6.2%
2/32 • Up to 28 months
Death reported under placebo arm was not treatment-emergent.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place