Trial Outcomes & Findings for Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis (NCT NCT02479802)
NCT ID: NCT02479802
Last Updated: 2020-06-16
Results Overview
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) includes 12 questions classified into 3 subdomains: bulbar function (3 questions), fine and gross motor skills (6 questions), and respiratory function (3 questions) to assess the level self sufficiency. Each task was graded according to a 5-point scale from 0 (incapable) to 4 (normal ability) with a total score from 0 (worst) to 48 (best).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Baseline, Weeks 4, 12, 25, 36, and 48
Results posted on
2020-06-16
Participant Flow
Participant milestones
| Measure |
Albumin
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Albumin
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis
Baseline characteristics by cohort
| Measure |
Albumin
n=13 Participants
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Age, Continuous
|
48.9 years
STANDARD_DEVIATION 9.86 • n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
Spain
|
13 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 12, 25, 36, and 48Population: Two subjects discontinued from the study early.
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) includes 12 questions classified into 3 subdomains: bulbar function (3 questions), fine and gross motor skills (6 questions), and respiratory function (3 questions) to assess the level self sufficiency. Each task was graded according to a 5-point scale from 0 (incapable) to 4 (normal ability) with a total score from 0 (worst) to 48 (best).
Outcome measures
| Measure |
Albumin
n=13 Participants
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Week 4
|
-1.0 units on a scale
Interval -1.0 to 0.0
|
|
Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Week 12
|
-1.5 units on a scale
Interval -4.0 to 0.0
|
|
Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Week 25
|
-4.0 units on a scale
Interval -8.0 to -3.0
|
|
Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Week 36
|
-5.5 units on a scale
Interval -9.0 to -3.0
|
|
Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Week 48
|
-10.0 units on a scale
Interval -14.0 to -7.0
|
PRIMARY outcome
Timeframe: Baseline, Weeks 4, 12, 25, 36, and 48Population: Two subjects discontinued from the study.
Outcome measures
| Measure |
Albumin
n=13 Participants
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC)
Week 48
|
-23.0 percentage of predicted value
Interval -38.0 to -9.0
|
|
Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC)
Week 4
|
-6.0 percentage of predicted value
Interval -9.0 to 2.0
|
|
Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC)
Week 12
|
-3.5 percentage of predicted value
Interval -12.5 to 0.0
|
|
Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC)
Week 25
|
-9.0 percentage of predicted value
Interval -23.0 to -6.0
|
|
Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC)
Week 36
|
-12.0 percentage of predicted value
Interval -22.0 to -12.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 25 and 48Population: Two subjects discontinued from the study.
ALS-CBS test is composed of 2 sections. The first section of the ALS-CBS test includes a questionnaire completed by the caregiver regarding behavior and symptoms status. It is comprised of 15 questions inquiring about possible changes over time in participant's behavior that the caregiver has noticed since the onset of ALS symptoms. Each item is scored on a scale ranging from 0 (worst) to 3 (best) yielding a total 0= large changes to 45=no changes. There were 4 additional questions related to current behavioral symptoms (depression, anxiety, fatigue, and emotional liability). Each question was scored as 0= the presence of symptoms and 1= no current symptoms, giving a total score between 0 and 4. The second section of the ALB-CBS test is for cognitive screening and consists of four items: attention, concentration, follow-up and monitoring, and initiation and recovery. These items were scored 0-5 with a maximum score of 20 (0= cognitive impairment, 20= no apparent cognitive impairment).
Outcome measures
| Measure |
Albumin
n=11 Participants
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Changes From Baseline in ALS Cognitive Function Determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) Test
Behavior Status Week 25
|
0.0 units on a scale
Interval -3.0 to 2.0
|
|
Changes From Baseline in ALS Cognitive Function Determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) Test
Symptom Status Week 48
|
0.0 units on a scale
Interval -1.0 to 1.0
|
|
Changes From Baseline in ALS Cognitive Function Determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) Test
Cognitive Screening Week 25
|
0.0 units on a scale
Interval -2.0 to 1.0
|
|
Changes From Baseline in ALS Cognitive Function Determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) Test
Behavior Status Week 48
|
-1.0 units on a scale
Interval -6.0 to 1.0
|
|
Changes From Baseline in ALS Cognitive Function Determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) Test
Symptom Status Week 25
|
0.0 units on a scale
Interval -1.0 to 1.0
|
|
Changes From Baseline in ALS Cognitive Function Determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) Test
Cognitive Screening Week 48
|
-1.0 units on a scale
Interval -3.0 to 2.0
|
SECONDARY outcome
Timeframe: Baseline, Weeks 4, 12, 25, 36, and 48Population: Two subjects were discontinued from the study.
Surface electromyography was performed to record motor evoked potential in the distal muscles of the upper limbs (thenar and hypothenar eminence) and dorsiflexor muscles of the lower limbs (anterior tibialis) after electrical stimulation.
Outcome measures
| Measure |
Albumin
n=13 Participants
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Tibialis Anterior Week 12
|
3.1 mV
Interval 0.6 to 5.5
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Tibialis Anterior Week 4
|
3.1 mV
Interval 0.4 to 5.3
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Tibialis Anterior Week 12
|
3.3 mV
Interval 0.1 to 5.2
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Thenar Eminence (APB) Week 4
|
4.4 mV
Interval 0.6 to 7.3
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Thenar Eminence (APB) Week 12
|
3.0 mV
Interval 0.9 to 4.1
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Thenar Eminence (APB) Week 36
|
0.6 mV
Interval 0.2 to 2.7
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Thenar Eminence (APB) Week 48
|
0.5 mV
Interval 0.2 to 1.2
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Hypothenar Eminence (ADM) Week 36
|
4.0 mV
Interval 0.2 to 7.0
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Hypothenar Eminence (ADM) Week 48
|
2.4 mV
Interval 0.4 to 7.3
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Tibialis Anterior Week 0
|
2.6 mV
Interval 0.5 to 6.2
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Tibialis Anterior Week 4
|
4.9 mV
Interval 1.5 to 7.1
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Tibialis Anterior Week 25
|
1.9 mV
Interval 0.4 to 4.5
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Tibialis Anterior Week 36
|
2.1 mV
Interval 0.3 to 5.5
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Tibialis Anterior Week 48
|
1.2 mV
Interval 0.0 to 3.2
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Tibialis Anterior Week 0
|
3.2 mV
Interval 1.2 to 6.6
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Tibialis Anterior Week 25
|
2.6 mV
Interval 0.1 to 4.3
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Tibialis Anterior Week 36
|
2.1 mV
Interval 0.2 to 4.1
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Tibialis Anterior Week 48
|
1.0 mV
Interval 0.0 to 3.7
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Thenar Eminence (APB) Week 0
|
4.0 mV
Interval 0.6 to 9.4
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Thenar Eminence (APB) Week 25
|
2.6 mV
Interval 0.4 to 3.7
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Thenar Eminence (APB) Week 36
|
1.2 mV
Interval 0.4 to 3.4
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Thenar Eminence (APB) Week 48
|
0.6 mV
Interval 0.1 to 3.1
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Thenar Eminence (APB) Week 0
|
6.4 mV
Interval 1.4 to 8.7
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Thenar Eminence (APB) Week 4
|
2.6 mV
Interval 0.9 to 6.2
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Thenar Eminence (APB) Week 12
|
3.1 mV
Interval 0.6 to 6.4
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Thenar Eminence (APB) Week 25
|
1.9 mV
Interval 0.2 to 6.0
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Hypothenar Eminence (ADM) Week 0
|
6.4 mV
Interval 0.6 to 8.1
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Hypothenar Eminence (ADM) Week 4
|
7.4 mV
Interval 6.3 to 7.9
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Hypothenar Eminence (ADM) Week 12
|
5.8 mV
Interval 2.7 to 8.1
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Hypothenar Eminence (ADM) Week 25
|
5.1 mV
Interval 2.6 to 5.8
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Hypothenar Eminence (ADM) Week 36
|
5.0 mV
Interval 2.8 to 6.1
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Right Hypothenar Eminence (ADM) Week 48
|
3.2 mV
Interval 0.6 to 6.9
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Hypothenar Eminence (ADM) Week 0
|
6.2 mV
Interval 3.3 to 8.8
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Hypothenar Eminence (ADM) Week 4
|
5.5 mV
Interval 3.5 to 8.2
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Hypothenar Eminence (ADM) Week 12
|
4.4 mV
Interval 2.1 to 7.4
|
|
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Left Hypothenar Eminence (ADM) Week 25
|
3.8 mV
Interval 1.1 to 6.5
|
SECONDARY outcome
Timeframe: Baseline, Weeks 25 and 48Population: Two subject discontinued from the study early.
The Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-40) consists of 40 items grouped into 5 representative dimensions associated with quality of life. The first 4 scales (physical mobility, activities of daily living, food and drink, communication) refer to deficits and subsequent disabilities as a result of the disease. The fifth scale (emotional functioning) reflects how the subject is facing his/her physical deterioration emotionally. Each item is scored from 0 to 4 according to a gradation of symptom onset frequency (never, rarely, sometimes, often, and always). From raw scores, an index from 0 to 100 is obtained for each dimension, which allow comparisons to be made with the other dimensions as well as a straightforward interpretation of results (0 = better state of health as measured by the questionnaire; 100 = poorer state of health).
Outcome measures
| Measure |
Albumin
n=11 Participants
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
Physical Mobility Week 25
|
10.0 units on a scale
Interval 0.0 to 20.0
|
|
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
Physical Mobility Week 48
|
32.5 units on a scale
Interval 7.5 to 50.0
|
|
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
ADL/Independence Week 25
|
12.5 units on a scale
Interval -2.5 to 45.0
|
|
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
ADL/Independence Week 48
|
25.0 units on a scale
Interval 7.5 to 45.0
|
|
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
Eating and Drinking Week 25
|
0.0 units on a scale
Interval 0.0 to 25.0
|
|
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
Eating and Drinking Week 48
|
8.3 units on a scale
Interval 0.0 to 58.3
|
|
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
Communication Week 25
|
0.0 units on a scale
Interval 0.0 to 28.6
|
|
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
Communication Week 48
|
0.0 units on a scale
Interval 0.0 to 35.7
|
|
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
Emotional Functioning Week 25
|
5.0 units on a scale
Interval -2.5 to 22.5
|
|
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
Emotional Functioning Week 48
|
7.5 units on a scale
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: During the Treatment Phase (24 weeks)Outcome measures
| Measure |
Albumin
n=330 Number of PE sessions
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Percentage of Plasma Exchange Sessions Associated With One Adverse Event or Adverse Reaction, Including Clinically Significant Changes in Vital Signs or Lab Parameters
|
0.9 percentage of PE sessions
Standard Deviation 2.22
|
Adverse Events
Albumin
Serious events: 4 serious events
Other events: 12 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Albumin
n=13 participants at risk
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Infections and infestations
Pneumonia
|
15.4%
2/13 • Number of events 2 • Adverse events were collected throughout the study (48 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
Other adverse events
| Measure |
Albumin
n=13 participants at risk
Plasma exchange with Albumin
Albumin: 27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
* three weeks of intensive treatment with two plasma exchanges per week
* twenty-one weeks of maintenance treatment with one weekly plasma exchange
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Gastrointestinal disorders
Diarrhoea
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Gastrointestinal disorders
Nausea
|
15.4%
2/13 • Number of events 2 • Adverse events were collected throughout the study (48 weeks).
|
|
Gastrointestinal disorders
Toothache
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Infections and infestations
Nasopharyngitis
|
46.2%
6/13 • Number of events 6 • Adverse events were collected throughout the study (48 weeks).
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Injury, poisoning and procedural complications
Chest injury
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Injury, poisoning and procedural complications
Fall
|
15.4%
2/13 • Number of events 2 • Adverse events were collected throughout the study (48 weeks).
|
|
Investigations
Weight decreased
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Nervous system disorders
Dizziness
|
15.4%
2/13 • Number of events 2 • Adverse events were collected throughout the study (48 weeks).
|
|
Nervous system disorders
Headache
|
23.1%
3/13 • Number of events 3 • Adverse events were collected throughout the study (48 weeks).
|
|
Nervous system disorders
Presyncope
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Psychiatric disorders
Anxiety
|
23.1%
3/13 • Number of events 3 • Adverse events were collected throughout the study (48 weeks).
|
|
Psychiatric disorders
Depression
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Psychiatric disorders
Insomnia
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal ulcer
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Surgical and medical procedures
Mechanical ventilation
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
|
Infections and infestations
Respiratory tract infection
|
7.7%
1/13 • Number of events 1 • Adverse events were collected throughout the study (48 weeks).
|
Additional Information
Miquel Barcelo, PhD
Grifols Bioscience Industrial Group
Phone: +34 935.712.368
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place