Trial Outcomes & Findings for The Paediatric EVICEL® Neuro Study (NCT NCT02309645)
NCT ID: NCT02309645
Last Updated: 2023-07-14
Results Overview
Percentage of participants with success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage were reported. Success is defined as no CSF leakage from dural repair intraoperatively, during Valsalva Maneuver 20-25 centimeters (cm) water (H2O) for 5-10 seconds.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
40 participants
Primary outcome timeframe
Intraoperative (up to 1 day)
Results posted on
2023-07-14
Participant Flow
One participant was randomized to 'Sutures Only' arm but received EVICEL, and hence this participant was analyzed in the 'Sutures Only' arm for efficacy analysis (full analysis set \[FAS\]) and in the EVICEL arm for safety analysis.
Participant milestones
| Measure |
EVICEL Fibrin Sealant
Participants who underwent craniectomy or craniotomy and had an intra-operative cerebrospinal fluid (CSF) leak, received up to 2 applications (maximum 4 layers) of EVICEL; applied to cover the entire length of the suture line and the adjacent area to at least 5 millimeters (mm) away, including all suture holes.
|
Sutures Only (Control)
Participants who underwent craniectomy or craniotomy and had an intra-operative CSF leak, received additional dural repair sutures as deemed necessary by the surgeon.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
14
|
|
Overall Study
Full Analysis Set (FAS)
|
25
|
15
|
|
Overall Study
COMPLETED
|
26
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
EVICEL Fibrin Sealant
n=25 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative cerebrospinal fluid (CSF) leak, received up to 2 applications (maximum 4 layers) of EVICEL; applied to cover the entire length of the suture line and the adjacent area to at least 5 millimeters (mm) away, including all suture holes.
|
Sutures Only (Control)
n=15 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative CSF leak, received additional dural repair sutures as deemed necessary by the surgeon.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
9.7 years
STANDARD_DEVIATION 4.4 • n=25 Participants
|
9.2 years
STANDARD_DEVIATION 4.3 • n=15 Participants
|
9.5 years
STANDARD_DEVIATION 4.3 • n=40 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=25 Participants
|
6 Participants
n=15 Participants
|
17 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=25 Participants
|
9 Participants
n=15 Participants
|
23 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Intraoperative (up to 1 day)Population: The full analysis set (FAS) consisted of all randomized participants.
Percentage of participants with success (intraoperative watertight closure) in the treatment of intraoperative CSF leakage were reported. Success is defined as no CSF leakage from dural repair intraoperatively, during Valsalva Maneuver 20-25 centimeters (cm) water (H2O) for 5-10 seconds.
Outcome measures
| Measure |
EVICEL Fibrin Sealant
n=25 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative cerebrospinal fluid (CSF) leak, received up to 2 applications (maximum 4 layers) of EVICEL; applied to cover the entire length of the suture line and the adjacent area to at least 5 millimeters (mm) away, including all suture holes.
|
Sutures Only (Control)
n=15 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative CSF leak, received additional dural repair sutures as deemed necessary by the surgeon.
|
|---|---|---|
|
Percentage of Participants With Success (Intraoperative Watertight Closure) in the Treatment of Intraoperative Cerebrospinal Fluid (CSF) Leakage
|
92.0 Percentage of participants
|
33.3 Percentage of participants
|
SECONDARY outcome
Timeframe: Up to 7 days post-operativelyPopulation: The safety analysis set consisted of all participants who received treatment.
Number of participants experiencing CSF leakage within 7 days post-operatively were reported.
Outcome measures
| Measure |
EVICEL Fibrin Sealant
n=26 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative cerebrospinal fluid (CSF) leak, received up to 2 applications (maximum 4 layers) of EVICEL; applied to cover the entire length of the suture line and the adjacent area to at least 5 millimeters (mm) away, including all suture holes.
|
Sutures Only (Control)
n=14 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative CSF leak, received additional dural repair sutures as deemed necessary by the surgeon.
|
|---|---|---|
|
Number of Participants Experiencing CSF Leakage Within 7 Days Post-operatively
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 33 days post-operativelyPopulation: The safety analysis set consisted of all participants who received treatment.
Number of participants experiencing CSF leakage within 33 days post-operatively were reported.
Outcome measures
| Measure |
EVICEL Fibrin Sealant
n=26 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative cerebrospinal fluid (CSF) leak, received up to 2 applications (maximum 4 layers) of EVICEL; applied to cover the entire length of the suture line and the adjacent area to at least 5 millimeters (mm) away, including all suture holes.
|
Sutures Only (Control)
n=14 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative CSF leak, received additional dural repair sutures as deemed necessary by the surgeon.
|
|---|---|---|
|
Number of Participants Experiencing CSF Leakage Within 33 Days Post-operatively
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Up to 33 daysPopulation: The safety analysis set consisted of all participants who received treatment.
An adverse event was any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE (also referred to as an adverse experience) could be any unfavorable and unintended sign, symptom, or disease temporarily associated with the use of a drug, without judgment about causality. Since post-operative pain was an expected outcome of this type of surgery, for purposes of this study, only exacerbations of expected post-operative pain based on the investigator's judgment was reported as an AE.
Outcome measures
| Measure |
EVICEL Fibrin Sealant
n=26 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative cerebrospinal fluid (CSF) leak, received up to 2 applications (maximum 4 layers) of EVICEL; applied to cover the entire length of the suture line and the adjacent area to at least 5 millimeters (mm) away, including all suture holes.
|
Sutures Only (Control)
n=14 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative CSF leak, received additional dural repair sutures as deemed necessary by the surgeon.
|
|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
22 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: Up to 33 daysPopulation: The safety analysis set consisted of all participants who received treatment.
Number of participants with SSI according to NHSN criteria within 33 days post-operatively were reported. NHSN CRITERIA states that infections occur within 33 days after the operation and infection involves only skin or subcutaneous tissue of the incision and at least one of the following: a) Purulent drainage, with or without laboratory confirmation, from the superficial incision; b) Organisms isolated from an aseptically obtained culture or fluid or tissue from the superficial incision; c) At least one of the following signs or symptoms of infection: pain or tenderness, localized swelling, redness, or heat and superficial incision is deliberately open by surgeon, unless incision is culture-negative; d) Diagnosis of superficial incisional SSI by the surgeon or attending physician.
Outcome measures
| Measure |
EVICEL Fibrin Sealant
n=26 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative cerebrospinal fluid (CSF) leak, received up to 2 applications (maximum 4 layers) of EVICEL; applied to cover the entire length of the suture line and the adjacent area to at least 5 millimeters (mm) away, including all suture holes.
|
Sutures Only (Control)
n=14 Participants
Participants who underwent craniectomy or craniotomy and had an intra-operative CSF leak, received additional dural repair sutures as deemed necessary by the surgeon.
|
|---|---|---|
|
Number of Participants With Surgical Site Infections (SSI) According to National Healthcare Safety Network (NHSN) Criteria Within 33 Days Post-operatively
|
1 Participants
|
1 Participants
|
Adverse Events
EVICEL Fibrin Sealant
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Sutures Only (Control)
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
EVICEL Fibrin Sealant
n=26 participants at risk
Participants who underwent craniectomy or craniotomy and had an intra-operative cerebrospinal fluid (CSF) leak, received up to 2 applications (maximum 4 layers) of EVICEL; applied to cover the entire length of the suture line and the adjacent area to at least 5 millimeters (mm) away, including all suture holes.
|
Sutures Only (Control)
n=14 participants at risk
Participants who underwent craniectomy or craniotomy and had an intra-operative CSF leak, received additional dural repair sutures as deemed necessary by the surgeon.
|
|---|---|---|
|
Congenital, familial and genetic disorders
Neurofibromatosis
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Endocrine disorders
Diabetes insipidus
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
0.00%
0/14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
General disorders
Hemorrhagic cyst
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
General disorders
Pyrexia
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
0.00%
0/14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Infections and infestations
Meningitis
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
0.00%
0/14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Infections and infestations
Shunt infection
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Post procedural hematoma
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Pseudomeningocele
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
28.6%
4/14 • Number of events 4 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Subdural hematoma
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Medulloblastoma recurrent
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
0.00%
0/14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Convulsion
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
0.00%
0/14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Hydrocephalus
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Pneumocephalus
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Transverse sinus thrombosis
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
Other adverse events
| Measure |
EVICEL Fibrin Sealant
n=26 participants at risk
Participants who underwent craniectomy or craniotomy and had an intra-operative cerebrospinal fluid (CSF) leak, received up to 2 applications (maximum 4 layers) of EVICEL; applied to cover the entire length of the suture line and the adjacent area to at least 5 millimeters (mm) away, including all suture holes.
|
Sutures Only (Control)
n=14 participants at risk
Participants who underwent craniectomy or craniotomy and had an intra-operative CSF leak, received additional dural repair sutures as deemed necessary by the surgeon.
|
|---|---|---|
|
Cardiac disorders
Bradycardia
|
7.7%
2/26 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Cardiac disorders
Dilatation ventricular
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Cardiac disorders
Tachycardia
|
7.7%
2/26 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
21.4%
3/14 • Number of events 3 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Eye disorders
Eye Swelling
|
15.4%
4/26 • Number of events 4 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
28.6%
4/14 • Number of events 4 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Eye disorders
Diplopia
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Gastrointestinal disorders
Nausea
|
19.2%
5/26 • Number of events 5 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
28.6%
4/14 • Number of events 4 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Gastrointestinal disorders
Vomiting
|
46.2%
12/26 • Number of events 14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
42.9%
6/14 • Number of events 9 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
21.4%
3/14 • Number of events 4 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
General disorders
Pyrexia
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
35.7%
5/14 • Number of events 8 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
General disorders
Catheter site pain
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
General disorders
Catheter site related reaction
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
General disorders
Fatigue
|
7.7%
2/26 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
0.00%
0/14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
General disorders
Implant site effusion
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
General disorders
Pain
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Infections and infestations
Rhinitis
|
7.7%
2/26 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
0.00%
0/14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
23.1%
6/26 • Number of events 6 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
21.4%
3/14 • Number of events 4 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Post procedural constipation
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Postoperative wound complication
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Procedural vomiting
|
7.7%
2/26 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Injury, poisoning and procedural complications
Wound complication
|
7.7%
2/26 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Investigations
Blood pressure diastolic decreased
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Investigations
Haemoglobin decreased
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.7%
2/26 • Number of events 3 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
11.5%
3/26 • Number of events 3 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
0.00%
0/14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.5%
3/26 • Number of events 3 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
0.00%
0/14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Headache
|
34.6%
9/26 • Number of events 11 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
35.7%
5/14 • Number of events 6 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Hemiplegia
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
IIIrd nerve paralysis
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Pneumocephalus
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Sensory loss
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Nervous system disorders
Transverse sinus thrombosis
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Reproductive system and breast disorders
Scrotal swelling
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.7%
2/26 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
0.00%
0/14 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/26 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
7.1%
1/14 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
|
Vascular disorders
Hypotension
|
3.8%
1/26 • Number of events 1 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
14.3%
2/14 • Number of events 2 • Up to 33 days
The safety analysis set consisted of all participants who received treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Draft abstracts, manuscripts, and materials for presentation at scientific meetings must be sent to the sponsor at least 60 working days prior to abstract or other relevant submission deadlines. Authorship of publications resulting from this study was based on generally accepted criteria for major medical journals.
- Publication restrictions are in place
Restriction type: OTHER