Trial Outcomes & Findings for Phase 3 Study of Dexpramipexole in ALS (NCT NCT01281189)
NCT ID: NCT01281189
Last Updated: 2021-06-07
Results Overview
The Composite Assessment of Function and Survival (CAFS) is a between-group comparison of a single ranked clinical outcome based on (1) the change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) score and (2) time to death. Each subject is ranked according to time-to-death (earlier deaths ranked lower than later deaths). Subjects who survive are ranked more favorably than subjects who died. Among the survivors, subjects are ranked according to change in ALSFRS-R (greater worsening of ALSFRS-R is ranked lower than less worsening or an improvement in ALSFRS-R). The ranked scores range from 001 to 941 (the number of subjects in the Efficacy Population) with larger rank score numbers associated with a better outcome. The ranks were analyzed using an ANCOVA model, which includes treatment as a fixed effect and adjusts for baseline ALSFRS-R score, duration of symptoms, site of onset, and use of riluzole. The least square mean rank score is presented for each treatment group.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
942 participants
Primary outcome timeframe
12 months
Results posted on
2021-06-07
Participant Flow
There were 942 participants (468 received placebo and 474 received dexpramipexole) recruited from 81 investigational sites in 11 countries worldwide. One additional participant was randomized in error and was not dosed. This subject was assigned to the placebo arm, but was removed from the intent-to-treat population as a result of the unintentional randomization performed in error by the site.
Participant milestones
| Measure |
Placebo
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
|---|---|---|
|
Overall Study
STARTED
|
468
|
474
|
|
Overall Study
COMPLETED
|
321
|
331
|
|
Overall Study
NOT COMPLETED
|
147
|
143
|
Reasons for withdrawal
| Measure |
Placebo
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
|---|---|---|
|
Overall Study
Adverse Event
|
7
|
9
|
|
Overall Study
Lost to Follow-up
|
6
|
4
|
|
Overall Study
Withdrawal by Subject
|
21
|
24
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Death
|
103
|
91
|
|
Overall Study
Other
|
8
|
12
|
Baseline Characteristics
Not all subject in the safety population had valid weights collected at Baseline
Baseline characteristics by cohort
| Measure |
Placebo
n=468 Participants
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
n=474 Participants
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
Total
n=942 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (yrs) · <50
|
114 Participants
n=468 Participants
|
114 Participants
n=474 Participants
|
228 Participants
n=942 Participants
|
|
Age, Customized
Age (yrs) · 50-65
|
233 Participants
n=468 Participants
|
244 Participants
n=474 Participants
|
477 Participants
n=942 Participants
|
|
Age, Customized
Age (yrs) · >65
|
121 Participants
n=468 Participants
|
116 Participants
n=474 Participants
|
237 Participants
n=942 Participants
|
|
Sex: Female, Male
Female
|
170 Participants
n=468 Participants
|
167 Participants
n=474 Participants
|
337 Participants
n=942 Participants
|
|
Sex: Female, Male
Male
|
298 Participants
n=468 Participants
|
307 Participants
n=474 Participants
|
605 Participants
n=942 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
7 Participants
n=468 Participants
|
4 Participants
n=474 Participants
|
11 Participants
n=942 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
10 Participants
n=468 Participants
|
3 Participants
n=474 Participants
|
13 Participants
n=942 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
439 Participants
n=468 Participants
|
450 Participants
n=474 Participants
|
889 Participants
n=942 Participants
|
|
Race/Ethnicity, Customized
Race · Not reported
|
7 Participants
n=468 Participants
|
9 Participants
n=474 Participants
|
16 Participants
n=942 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
5 Participants
n=468 Participants
|
8 Participants
n=474 Participants
|
13 Participants
n=942 Participants
|
|
Weight
|
77.76 kg
STANDARD_DEVIATION 16.008 • n=465 Participants • Not all subject in the safety population had valid weights collected at Baseline
|
77.21 kg
STANDARD_DEVIATION 15.027 • n=471 Participants • Not all subject in the safety population had valid weights collected at Baseline
|
77.48 kg
STANDARD_DEVIATION 15.516 • n=936 Participants • Not all subject in the safety population had valid weights collected at Baseline
|
|
Height
|
172.0 cm
STANDARD_DEVIATION 10.22 • n=468 Participants
|
172.0 cm
STANDARD_DEVIATION 9.30 • n=474 Participants
|
172.0 cm
STANDARD_DEVIATION 9.77 • n=942 Participants
|
|
Body mass index
|
26.15 kg/m^2
STANDARD_DEVIATION 4.330 • n=465 Participants • Not all subject in the safety population had valid weights collected at Baseline, therefore BMI could not be calculated.
|
26.00 kg/m^2
STANDARD_DEVIATION 4.239 • n=471 Participants • Not all subject in the safety population had valid weights collected at Baseline, therefore BMI could not be calculated.
|
26.08 kg/m^2
STANDARD_DEVIATION 4.283 • n=936 Participants • Not all subject in the safety population had valid weights collected at Baseline, therefore BMI could not be calculated.
|
|
ALS family history
Yes
|
26 Participants
n=468 Participants
|
33 Participants
n=474 Participants
|
59 Participants
n=942 Participants
|
|
ALS family history
No
|
442 Participants
n=468 Participants
|
440 Participants
n=474 Participants
|
882 Participants
n=942 Participants
|
|
ALS family history
Missing
|
0 Participants
n=468 Participants
|
1 Participants
n=474 Participants
|
1 Participants
n=942 Participants
|
|
Time since ALS symptom onset
|
15.53 months
STANDARD_DEVIATION 5.411 • n=468 Participants
|
14.92 months
STANDARD_DEVIATION 5.251 • n=474 Participants
|
15.22 months
STANDARD_DEVIATION 5.337 • n=942 Participants
|
|
Site of onset
Bulbar
|
112 Participants
n=468 Participants
|
107 Participants
n=474 Participants
|
219 Participants
n=942 Participants
|
|
Site of onset
Other
|
356 Participants
n=468 Participants
|
367 Participants
n=474 Participants
|
723 Participants
n=942 Participants
|
|
Time since ALS diagnosis
|
7.62 months
STANDARD_DEVIATION 5.015 • n=468 Participants
|
7.22 months
STANDARD_DEVIATION 4.718 • n=474 Participants
|
7.42 months
STANDARD_DEVIATION 4.869 • n=942 Participants
|
|
El Escorial Criteria for ALS
Possible
|
44 Participants
n=468 Participants
|
44 Participants
n=474 Participants
|
88 Participants
n=942 Participants
|
|
El Escorial Criteria for ALS
Probable laboratory supported
|
94 Participants
n=468 Participants
|
98 Participants
n=474 Participants
|
192 Participants
n=942 Participants
|
|
El Escorial Criteria for ALS
Probable
|
174 Participants
n=468 Participants
|
185 Participants
n=474 Participants
|
359 Participants
n=942 Participants
|
|
El Escorial Criteria for ALS
Definite
|
156 Participants
n=468 Participants
|
147 Participants
n=474 Participants
|
303 Participants
n=942 Participants
|
|
Concomitant use of riluzole
Yes
|
349 Participants
n=468 Participants
|
359 Participants
n=474 Participants
|
708 Participants
n=942 Participants
|
|
Concomitant use of riluzole
No
|
119 Participants
n=468 Participants
|
115 Participants
n=474 Participants
|
234 Participants
n=942 Participants
|
|
Baseline ALSFRS-R total scores
|
37.9 units on a scale
STANDARD_DEVIATION 5.65 • n=468 Participants
|
38.4 units on a scale
STANDARD_DEVIATION 5.24 • n=474 Participants
|
38.2 units on a scale
STANDARD_DEVIATION 5.45 • n=942 Participants
|
|
Baseline predicted upright slow vital capacity (%)
<65%
|
27 Participants
n=468 Participants
|
28 Participants
n=474 Participants
|
55 Participants
n=942 Participants
|
|
Baseline predicted upright slow vital capacity (%)
65-75%
|
84 Participants
n=468 Participants
|
79 Participants
n=474 Participants
|
163 Participants
n=942 Participants
|
|
Baseline predicted upright slow vital capacity (%)
>75%
|
357 Participants
n=468 Participants
|
367 Participants
n=474 Participants
|
724 Participants
n=942 Participants
|
|
Baseline predicted upright slow vital capacity (%)
|
89.1 %
STANDARD_DEVIATION 17.71 • n=468 Participants
|
89.0 %
STANDARD_DEVIATION 17.57 • n=474 Participants
|
89.1 %
STANDARD_DEVIATION 17.63 • n=942 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The efficacy population is defined as subjects who were randomized and received at least 1 dose of study treatment and who either had at least 1 available post-dosing efficacy evaluation (ALSFRS-R) or died during the study period. Subjects were analyzed in the treatment group to which they are randomized.
The Composite Assessment of Function and Survival (CAFS) is a between-group comparison of a single ranked clinical outcome based on (1) the change from baseline in ALS Functional Rating Scale-Revised (ALSFRS-R) score and (2) time to death. Each subject is ranked according to time-to-death (earlier deaths ranked lower than later deaths). Subjects who survive are ranked more favorably than subjects who died. Among the survivors, subjects are ranked according to change in ALSFRS-R (greater worsening of ALSFRS-R is ranked lower than less worsening or an improvement in ALSFRS-R). The ranked scores range from 001 to 941 (the number of subjects in the Efficacy Population) with larger rank score numbers associated with a better outcome. The ranks were analyzed using an ANCOVA model, which includes treatment as a fixed effect and adjusts for baseline ALSFRS-R score, duration of symptoms, site of onset, and use of riluzole. The least square mean rank score is presented for each treatment group.
Outcome measures
| Measure |
Placebo
n=468 Participants
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
n=473 Participants
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
|---|---|---|
|
Composite Assessment of Function and Survival (CAFS) at 12 Months
|
438.84 units on a scale
Interval 412.807 to 464.878
|
441.76 units on a scale
Interval 415.426 to 468.084
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The efficacy population is defined as subjects who were randomized and received at least 1 dose of study treatment and who either had at least 1 available post-dosing efficacy evaluation (ALSFRS-R) or died during the study period. Subjects were analyzed in the treatment group to which they are randomized.
The longest duration of follow-up for this time to the death analysis was 12 months. In the study, subjects were followed for 12-18 months.
Outcome measures
| Measure |
Placebo
n=468 Participants
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
n=473 Participants
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
|---|---|---|
|
Death up to 12 Months (CAFs Individual Component)
|
17.2 percentage of participants
|
16.0 percentage of participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The efficacy population is defined as subjects who were randomized and received at least 1 dose of study treatment and who either had at least 1 available post-dosing efficacy evaluation (ALSFRS-R) or died during the study period. Subjects will be analyzed in the treatment group to which they are randomized.
The ALSFRS-R (ALS functional rating scale with respiratory component) is a validated scale which measures 4 functional domains, comprising respiratory function, bulbar function, gross motor skills, and fine motor skills. There are a total of 12 questions, each scored from 0 to 4 for a total possible score of 48, with higher scores representing better function.
Outcome measures
| Measure |
Placebo
n=468 Participants
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
n=473 Participants
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
|---|---|---|
|
Change From Baseline in ALSFRS-R at 12 Months (CAFs Individual Component)
|
-13.415 units on a scale
Interval -14.275 to -12.555
|
-13.339 units on a scale
Interval -14.199 to -12.48
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: The efficacy population is defined as subjects who were randomized and received at least 1 dose of study treatment and who either had at least 1 available post-dosing efficacy evaluation (ALSFRS-R) or died during the study period. Subjects were analyzed in the treatment group to which they are randomized.
Time to Death or Respiratory Insufficiency (DRI) is defined as receipt of a tracheostomy or the use of non-invasive ventilation (NIV) for ≥22 hours per day for at least 10 consecutive days. If NIV is used to meet the criteria for respiratory insufficiency, no measured slow vital capacity (SVC) at any subsequent assessment may be \>50%. Time to DRI is calculated from the date of the first dose to the first date of one of the following events: death, tracheostomy, or the 10th day of consecutive NIV with no measured SVC \>50% at any subsequent assessment.
Outcome measures
| Measure |
Placebo
n=468 Participants
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
n=474 Participants
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
|---|---|---|
|
Death or Respiratory Insufficiency (DRI) up to Month 18
|
27.2 percentage of participants
|
22.3 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: Subjects who were randomized, received at least 1 dose of study treatment, had at least 1 available post-dosing efficacy evaluation (ALSFRS-R) or died during the study period. Subjects were analyzed in the treatment group to which they are randomized. An attempt was made to collect living status for each subject 18 months after randomization, regardless of the subject's disposition in the study (active or discontinued) or primary reasons for discontinuation.
Estimated time to death up to 18 months. This includes deaths reported greater than 30 days following discontinuation from the study (the time period for reporting all-cause mortality), regardless of subject disposition, up to 18 months from first dose.
Outcome measures
| Measure |
Placebo
n=468 Participants
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
n=474 Participants
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
|---|---|---|
|
Death up to 18 Months
|
23.1 percentage of participants
|
20.5 percentage of participants
|
SECONDARY outcome
Timeframe: 18 monthsPopulation: The intent-to-treat (ITT) population is defined as subjects who were randomized and received at least 1 dose of study treatment.
The date of reaching ≤50% of predicted upright slow vital capacity (SVC) is defined as the date of the first visit at which a predicted upright SVC is ≤50% and continues to remain ≤50% at the subsequent visit except for the last available observation. The time to reach ≤50% of predicted upright SVC is defined as the duration between the date of reaching ≤50% of predicted upright SVC and the date of the first dose of study medication. If the subject is alive and does not reach ≤50% of predicted upright SVC, the time to reach ≤50% of predicted upright SVC will be censored and equal to the number of days from the first dose of study medication until the visit date when the subject's last available SVC assessment is performed. The earliest time (Reaching ≤50% Predicted Upright SVC or death) is used in analysis.
Outcome measures
| Measure |
Placebo
n=468 Participants
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
n=474 Participants
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
|---|---|---|
|
≤50% Predicted Upright Slow Vital Capacity (SVC) or Died up to 18 Months
|
41.9 percentage of participants
|
36.5 percentage of participants
|
Adverse Events
Placebo
Serious events: 233 serious events
Other events: 447 other events
Deaths: 108 deaths
Dexpramipexole
Serious events: 225 serious events
Other events: 459 other events
Deaths: 97 deaths
Serious adverse events
| Measure |
Placebo
n=468 participants at risk
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
n=474 participants at risk
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY TRACT CONGESTION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
SLEEP APNOEA SYNDROME
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
UPPER AIRWAY OBSTRUCTION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Gastrointestinal disorders
COLITIS
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Gastrointestinal disorders
INTESTINAL OBSTRUCTION
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Gastrointestinal disorders
STOMATITIS
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Gastrointestinal disorders
GASTRITIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Gastrointestinal disorders
ILEUS
|
0.43%
2/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.43%
2/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.21%
1/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC DEGENERATION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
MOBILITY DECREASED
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
OSTEOARTHRITIS
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
POLYMYALGIA RHEUMATICA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
INCLUSION BODY MYOSITIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
INTERVERTEBRAL DISC PROTRUSION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
LUMBAR SPINAL STENOSIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
NOSE DEFORMITY
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
0.00%
0/468 • 18 months
|
0.63%
3/474 • 18 months
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.21%
1/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Renal and urinary disorders
HAEMATURIA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Renal and urinary disorders
NEPHROLITHIASIS
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Renal and urinary disorders
URETERIC STENOSIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Reproductive system and breast disorders
UTERINE POLYP
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Reproductive system and breast disorders
BREAST HAEMATOMA
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Reproductive system and breast disorders
VAGINAL HAEMORRHAGE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
General disorders
EUTHANASIA
|
0.21%
1/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
General disorders
NON-CARDIAC CHEST PAIN
|
0.00%
0/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
General disorders
SUDDEN DEATH
|
0.00%
0/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
General disorders
ADVERSE DRUG REACTION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
General disorders
ASTHENIA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
|
0.43%
2/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
INCREASED VISCOSITY OF BRONCHIAL SECRETION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGOSPASM
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ACIDOSIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
STRIDOR
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
VOCAL CORD DISORDER
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Gastrointestinal disorders
DYSPHAGIA
|
14.7%
69/468 • 18 months
|
13.1%
62/474 • 18 months
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.43%
2/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Gastrointestinal disorders
APHAGIA
|
0.21%
1/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.85%
4/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Gastrointestinal disorders
FAECALOMA
|
0.00%
0/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
General disorders
CHEST PAIN
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
General disorders
COMPLICATION OF DEVICE INSERTION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
General disorders
DEATH
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
General disorders
DEVICE MALFUNCTION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
General disorders
MEDICAL DEVICE COMPLICATION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
General disorders
PYREXIA
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
General disorders
ULCER HAEMORRHAGE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
General disorders
DEVICE LEAKAGE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
General disorders
DEVICE OCCLUSION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
General disorders
OEDEMA PERIPHERAL
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Investigations
VITAL CAPACITY DECREASED
|
0.64%
3/468 • 18 months
|
0.63%
3/474 • 18 months
|
|
Investigations
WEIGHT DECREASED
|
0.21%
1/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Investigations
INVESTIGATION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Investigations
LIVER FUNCTION TEST ABNORMAL
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Investigations
DIAGNOSTIC PROCEDURE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.43%
2/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Investigations
TOTAL LUNG CAPACITY DECREASED
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Injury, poisoning and procedural complications
FALL
|
2.4%
11/468 • 18 months
|
2.7%
13/474 • 18 months
|
|
Injury, poisoning and procedural complications
FACIAL BONES FRACTURE
|
0.21%
1/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Injury, poisoning and procedural complications
LACERATION
|
0.21%
1/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.64%
3/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Social circumstances
RESPITE CARE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Social circumstances
SOCIAL STAY HOSPITALISATION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Injury, poisoning and procedural complications
HAND FRACTURE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL HAEMORRHAGE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
RADIUS FRACTURE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
SPLENIC HAEMATOMA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
CLAVICLE FRACTURE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Injury, poisoning and procedural complications
HEAD INJURY
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Injury, poisoning and procedural complications
INTENTIONAL OVERDOSE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
CONCUSSION
|
0.43%
2/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
CRANIOCEREBRAL INJURY
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
FOREIGN BODY
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
GASTROINTESTINAL STOMA COMPLICATION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Injury, poisoning and procedural complications
SKELETAL INJURY
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Injury, poisoning and procedural complications
SKULL FRACTURED BASE
|
0.43%
2/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Injury, poisoning and procedural complications
TRAUMATIC INTRACRANIAL HAEMORRHAGE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Injury, poisoning and procedural complications
TRENCH FOOT
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Surgical and medical procedures
SUPPORTIVE CARE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.21%
1/468 • 18 months
|
1.9%
9/474 • 18 months
|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Blood and lymphatic system disorders
COAGULOPATHY
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Immune system disorders
HYPERSENSITIVITY
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.21%
1/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.00%
0/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.21%
1/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Metabolism and nutrition disorders
MALNUTRITION
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Metabolism and nutrition disorders
FLUID RETENTION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Psychiatric disorders
SUICIDAL IDEATION
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Psychiatric disorders
ALCOHOLISM
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Psychiatric disorders
ANXIETY
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Psychiatric disorders
DEPRESSION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Psychiatric disorders
DEPRESSION SUICIDAL
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Psychiatric disorders
PANIC ATTACK
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Nervous system disorders
AMYOTROPHIC LATERAL SCLEROSIS
|
3.4%
16/468 • 18 months
|
3.4%
16/474 • 18 months
|
|
Nervous system disorders
MOTOR NEURONE DISEASE
|
1.5%
7/468 • 18 months
|
0.63%
3/474 • 18 months
|
|
Nervous system disorders
MIGRAINE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Nervous system disorders
MUSCLE SPASTICITY
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Nervous system disorders
SOMNOLENCE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Nervous system disorders
SYNCOPE
|
0.43%
2/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Nervous system disorders
BULBAR PALSY
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Nervous system disorders
CEREBELLAR INFARCTION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Nervous system disorders
VERTEBRAL ARTERY DISSECTION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Eye disorders
CATARACT
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.64%
3/468 • 18 months
|
1.1%
5/474 • 18 months
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.21%
1/468 • 18 months
|
0.84%
4/474 • 18 months
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.43%
2/468 • 18 months
|
0.63%
3/474 • 18 months
|
|
Cardiac disorders
ARRHYTHMIA
|
0.00%
0/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Cardiac disorders
CARDIAC ARREST
|
0.00%
0/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.64%
3/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Cardiac disorders
CARDIOGENIC SHOCK
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Cardiac disorders
CARDIOVASCULAR DISORDER
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Cardiac disorders
SUPRAVENTRICULAR EXTRASYSTOLES
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Cardiac disorders
SUPRAVENTRICULAR TACHYCARDIA
|
0.43%
2/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Cardiac disorders
VENTRICULAR ARRHYTHMIA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.43%
2/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Cardiac disorders
DIASTOLIC DYSFUNCTION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Cardiac disorders
STRESS CARDIOMYOPATHY
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Cardiac disorders
TACHYCARDIA
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
1.7%
8/468 • 18 months
|
1.7%
8/474 • 18 months
|
|
Vascular disorders
ARTERIAL THROMBOSIS LIMB
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Vascular disorders
HAEMATOMA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Vascular disorders
HYPERTENSION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Vascular disorders
THROMBOSIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
16.0%
75/468 • 18 months
|
14.6%
69/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
2.8%
13/468 • 18 months
|
2.5%
12/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.9%
9/468 • 18 months
|
2.5%
12/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
2.1%
10/468 • 18 months
|
1.3%
6/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
1.1%
5/468 • 18 months
|
0.84%
4/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISORDER
|
1.3%
6/468 • 18 months
|
0.84%
4/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
1.3%
6/468 • 18 months
|
0.63%
3/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
1.3%
6/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC RESPIRATORY FAILURE
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH DECREASED
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
HYPERCAPNIA
|
0.85%
4/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
HYPOVENTILATION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
INCREASED BRONCHIAL SECRETION
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
LUNG DISORDER
|
0.64%
3/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
ORTHOPNOEA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY MUSCLE WEAKNESS
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
PNEUMONIA
|
4.1%
19/468 • 18 months
|
3.0%
14/474 • 18 months
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
1.3%
6/468 • 18 months
|
0.63%
3/474 • 18 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.64%
3/468 • 18 months
|
0.63%
3/474 • 18 months
|
|
Infections and infestations
BRONCHITIS
|
1.3%
6/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Infections and infestations
CELLULITIS
|
0.00%
0/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Infections and infestations
LUNG INFECTION
|
0.00%
0/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/468 • 18 months
|
0.42%
2/474 • 18 months
|
|
Infections and infestations
CATHETER SITE INFECTION
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
CLOSTRIDIUM DIFFICILE COLITIS
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
CYSTITIS ESCHERICHIA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
NEUTROPENIC INFECTION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
PILONIDAL CYST
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
PSEUDOMONAS BRONCHITIS
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
RHINITIS
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
RHINOVIRUS INFECTION
|
0.21%
1/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
VIRAL INFECTION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
VIRAL UPPER RESPIRATORY TRACT INFECTION
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Infections and infestations
GAS GANGRENE
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Infections and infestations
GASTROENTERITIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Infections and infestations
PNEUMONIA KLEBSIELLA
|
0.43%
2/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Infections and infestations
PYELONEPHRITIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS BRONCHITIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.43%
2/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Infections and infestations
SEPSIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Infections and infestations
SERRATIA INFECTION
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Infections and infestations
SINUSITIS
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT MELANOMA
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
NEOPLASM MALIGNANT
|
0.00%
0/468 • 18 months
|
0.21%
1/474 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CHRONIC LYMPHOCYTIC LEUKAEMIA
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC BRONCHIAL CARCINOMA
|
0.21%
1/468 • 18 months
|
0.00%
0/474 • 18 months
|
Other adverse events
| Measure |
Placebo
n=468 participants at risk
Matching Placebo: Oral tablet twice daily.
|
Dexpramipexole
n=474 participants at risk
Dexpramipexole: Oral tablet 150 mg twice daily. 300 mg/day
|
|---|---|---|
|
Infections and infestations
NASOPHARYNGITIS
|
16.2%
76/468 • 18 months
|
14.6%
69/474 • 18 months
|
|
Infections and infestations
URINARY TRACT INFECTION
|
12.0%
56/468 • 18 months
|
11.8%
56/474 • 18 months
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
3.6%
17/468 • 18 months
|
6.3%
30/474 • 18 months
|
|
Infections and infestations
PNEUMONIA
|
6.8%
32/468 • 18 months
|
5.1%
24/474 • 18 months
|
|
Infections and infestations
BRONCHITIS
|
6.0%
28/468 • 18 months
|
4.4%
21/474 • 18 months
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.7%
8/468 • 18 months
|
7.8%
37/474 • 18 months
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
5.8%
27/468 • 18 months
|
7.0%
33/474 • 18 months
|
|
Psychiatric disorders
INSOMNIA
|
12.8%
60/468 • 18 months
|
15.0%
71/474 • 18 months
|
|
Psychiatric disorders
DEPRESSION
|
10.7%
50/468 • 18 months
|
8.4%
40/474 • 18 months
|
|
Psychiatric disorders
ANXIETY
|
7.3%
34/468 • 18 months
|
7.4%
35/474 • 18 months
|
|
Nervous system disorders
HEADACHE
|
13.9%
65/468 • 18 months
|
13.9%
66/474 • 18 months
|
|
Nervous system disorders
DIZZINESS
|
6.0%
28/468 • 18 months
|
8.9%
42/474 • 18 months
|
|
Nervous system disorders
AMYOTROPHIC LATERAL SCLEROSIS
|
6.0%
28/468 • 18 months
|
5.1%
24/474 • 18 months
|
|
Vascular disorders
HYPERTENSION
|
2.8%
13/468 • 18 months
|
4.9%
23/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
17.3%
81/468 • 18 months
|
15.2%
72/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
6.4%
30/468 • 18 months
|
9.5%
45/474 • 18 months
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
11.1%
52/468 • 18 months
|
9.3%
44/474 • 18 months
|
|
Gastrointestinal disorders
CONSTIPATION
|
23.3%
109/468 • 18 months
|
27.2%
129/474 • 18 months
|
|
Gastrointestinal disorders
NAUSEA
|
13.9%
65/468 • 18 months
|
22.4%
106/474 • 18 months
|
|
Gastrointestinal disorders
DYSPHAGIA
|
20.3%
95/468 • 18 months
|
18.6%
88/474 • 18 months
|
|
Gastrointestinal disorders
DIARRHOEA
|
11.8%
55/468 • 18 months
|
9.3%
44/474 • 18 months
|
|
Gastrointestinal disorders
DRY MOUTH
|
4.3%
20/468 • 18 months
|
8.6%
41/474 • 18 months
|
|
Gastrointestinal disorders
SALIVARY HYPERSECRETION
|
7.3%
34/468 • 18 months
|
6.1%
29/474 • 18 months
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.8%
27/468 • 18 months
|
5.7%
27/474 • 18 months
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
3.8%
18/468 • 18 months
|
5.3%
25/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
9.4%
44/468 • 18 months
|
13.5%
64/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
7.9%
37/468 • 18 months
|
9.3%
44/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
7.3%
34/468 • 18 months
|
8.9%
42/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
7.7%
36/468 • 18 months
|
8.2%
39/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.4%
30/468 • 18 months
|
8.0%
38/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
6.0%
28/468 • 18 months
|
5.5%
26/474 • 18 months
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
1.9%
9/468 • 18 months
|
5.1%
24/474 • 18 months
|
|
General disorders
OEDEMA PERIPHERAL
|
15.4%
72/468 • 18 months
|
12.9%
61/474 • 18 months
|
|
General disorders
FATIGUE
|
12.8%
60/468 • 18 months
|
12.0%
57/474 • 18 months
|
|
General disorders
ASTHENIA
|
2.1%
10/468 • 18 months
|
4.9%
23/474 • 18 months
|
|
General disorders
PYREXIA
|
4.5%
21/468 • 18 months
|
4.6%
22/474 • 18 months
|
|
Investigations
WEIGHT DECREASED
|
10.3%
48/468 • 18 months
|
15.8%
75/474 • 18 months
|
|
Injury, poisoning and procedural complications
FALL
|
42.3%
198/468 • 18 months
|
40.5%
192/474 • 18 months
|
|
Injury, poisoning and procedural complications
LACERATION
|
6.6%
31/468 • 18 months
|
7.2%
34/474 • 18 months
|
|
Injury, poisoning and procedural complications
CONTUSION
|
7.5%
35/468 • 18 months
|
6.5%
31/474 • 18 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must be consulted
- Publication restrictions are in place
Restriction type: OTHER