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Trial Outcomes & Findings for Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS) (NCT NCT00330681)

NCT ID: NCT00330681

Last Updated: 2026-01-06

Results Overview

ALSFRS-R Score: 0=worst; 48=best

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

206 participants

Primary outcome timeframe

baseline and 24 weeks

Results posted on

2026-01-06

Participant Flow

Participant milestones

Participant milestones
Measure
MCI-186
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Study
STARTED
102
104
Overall Study
COMPLETED
93
90
Overall Study
NOT COMPLETED
9
14

Reasons for withdrawal

Reasons for withdrawal
Measure
MCI-186
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
Edaravone matched placebo, intravenously infused over 60 min once daily.
Overall Study
Adverse Event
3
6
Overall Study
Protocol Violation
0
1
Overall Study
Withdrawal by Subject
5
5
Overall Study
Tracheotomy due to worsening of ALS
1
2

Baseline Characteristics

Efficacy and Safety Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (ALS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MCI-186
n=102 Participants
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=104 Participants
Edaravone matched placebo, intravenously infused over 60 min once daily.
Total
n=206 Participants
Total of all reporting groups
Age, Customized
<=18 years
0 Participants
n=37 Participants
0 Participants
n=56 Participants
0 Participants
n=82 Participants
Age, Customized
Between 19 and 64 years
74 Participants
n=37 Participants
71 Participants
n=56 Participants
145 Participants
n=82 Participants
Age, Customized
>=65 years
28 Participants
n=37 Participants
33 Participants
n=56 Participants
61 Participants
n=82 Participants
Sex: Female, Male
Female
38 Participants
n=37 Participants
35 Participants
n=56 Participants
73 Participants
n=82 Participants
Sex: Female, Male
Male
64 Participants
n=37 Participants
69 Participants
n=56 Participants
133 Participants
n=82 Participants

PRIMARY outcome

Timeframe: baseline and 24 weeks

Population: "1 patient with diseases other than ALS" and "1 patient who did not reach the end of cycle 3" were excluded from the FAS in the MCI-186 group. "5 patients who did not reach the end of cycle 3" were excluded from the FAS in the Placebo of MCI-186 group.

ALSFRS-R Score: 0=worst; 48=best

Outcome measures

Outcome measures
Measure
MCI-186
n=100 Participants
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=99 Participants
Edaravone matched placebo, intravenously infused over 60 min once daily.
Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
-5.7 units on a scale
Standard Error 0.85
-6.35 units on a scale
Standard Error 0.84

SECONDARY outcome

Timeframe: 24 weeks

Population: "1 patient with diseases other than ALS" was excluded from the FAS in the MCI-186 group.

Any of "death, disability of independent ambulation, loss of upper arm function, tracheotomy, use of respirator, and use of tube feeding" was defined as an event.

Outcome measures

Outcome measures
Measure
MCI-186
n=101 Participants
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=104 Participants
Edaravone matched placebo, intravenously infused over 60 min once daily.
Death or a Specified State of Disease Progression
loss of upper arm function
2 participants
4 participants
Death or a Specified State of Disease Progression
tracheotomy
0 participants
2 participants
Death or a Specified State of Disease Progression
use of respirator
1 participants
3 participants
Death or a Specified State of Disease Progression
use of tube feeding
5 participants
3 participants
Death or a Specified State of Disease Progression
death
2 participants
2 participants
Death or a Specified State of Disease Progression
disability of independent ambulation
28 participants
23 participants

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: "1 patient with diseases other than ALS" and "1 patient who did not reach the end of cycle 3" were excluded from the FAS in the MCI-186 group. "5 patients who did not reach the end of cycle 3" were excluded from the FAS in the Placebo of MCI-186 group.

Outcome measures

Outcome measures
Measure
MCI-186
n=100 Participants
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=99 Participants
Edaravone matched placebo, intravenously infused over 60 min once daily.
Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
-14.57 percentage of FVC
Standard Error 2.41
-17.49 percentage of FVC
Standard Error 2.39

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: "1 patient with diseases other than ALS", "1 patient who did not reach the end of cycle 3" and "5 patients with missing data" were excluded from the FAS in the MCI-186 group. "5 patients who did not reach the end of cycle 3" and "2 patients with missing data" were excluded from the FAS in the Placebo of MCI-186 group.

The Modified Norris Scale is a measure of movement disorder for patients with ALS. Worst=0, Best=102

Outcome measures

Outcome measures
Measure
MCI-186
n=95 Participants
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=97 Participants
Edaravone matched placebo, intravenously infused over 60 min once daily.
Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks
-14.12 units on a scale
Standard Error 2.05
-16.15 units on a scale
Standard Error 2

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: "1 patient with diseases other than ALS", "1 patient who did not reach the end of cycle 3" and "5 patients with missing data" were excluded from the FAS in the MCI-186 group. "5 patients who did not reach the end of cycle 3" and "4 patients with missing data" were excluded from the FAS in the Placebo of MCI-186 group.

The ALSAQ40 score is a measure of QoL for patients with ALS. The ALSAQ40 evaluates domains that include physical mobility, ADL and independence, eating and drinking, communication, and emotional reactions. Worst=200, Best=40

Outcome measures

Outcome measures
Measure
MCI-186
n=95 Participants
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=95 Participants
Edaravone matched placebo, intravenously infused over 60 min once daily.
Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks
19.6 units on a scale
Standard Error 3.82
19.13 units on a scale
Standard Error 3.79

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure
MCI-186
n=102 Participants
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=104 Participants
Edaravone matched placebo, intravenously infused over 60 min once daily.
Percentage of Participants With Adverse Events
89.2 percentage of participants
88.5 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure
MCI-186
n=102 Participants
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=104 Participants
Edaravone matched placebo, intravenously infused over 60 min once daily.
Percentage of Participants With Adverse Drug Reactions
13.7 percentage of participants
19.2 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Population: "1 patient with missing data" was excluded from the FAS in the Placebo of MCI-186 group.

Outcome measures

Outcome measures
Measure
MCI-186
n=102 Participants
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=103 Participants
Edaravone matched placebo, intravenously infused over 60 min once daily.
Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group
White blood cell count
2 percentage of participants
5.8 percentage of participants
Percentage of Participants With Laboratory Tests for Which the Incidence of Abnormal Changes Was 5% or Higher in Either Group
urinary glucose
6.9 percentage of participants
2.9 percentage of participants

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure
MCI-186
n=102 Participants
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=104 Participants
Edaravone matched placebo, intravenously infused over 60 min once daily.
Percentage of Participants With Abnormal Changes in Sensory Examinations
Numbness
1 percentage of participants
1 percentage of participants
Percentage of Participants With Abnormal Changes in Sensory Examinations
Staggering
2 percentage of participants
3.8 percentage of participants
Percentage of Participants With Abnormal Changes in Sensory Examinations
Vibratory sensation
0 percentage of participants
1 percentage of participants

Adverse Events

MCI-186

Serious events: 18 serious events
Other events: 88 other events
Deaths: 0 deaths

Placebo of MCI-186

Serious events: 24 serious events
Other events: 91 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
MCI-186
n=102 participants at risk
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=104 participants at risk
Edaravone matched placebo, intravenously infused over 60 min once daily.
Ear and labyrinth disorders
Vertigo positional
0.00%
0/102
0.96%
1/104
Gastrointestinal disorders
Abdominal pain
0.98%
1/102
0.00%
0/104
Gastrointestinal disorders
Ascites
0.00%
0/102
0.96%
1/104
Gastrointestinal disorders
Dysphagia
7.8%
8/102
10.6%
11/104
Gastrointestinal disorders
Intestinal ischaemia
0.98%
1/102
0.00%
0/104
General disorders
Abasia
0.98%
1/102
0.00%
0/104
General disorders
Gait disturbance
2.9%
3/102
1.9%
2/104
General disorders
Oedema peripheral
0.00%
0/102
0.96%
1/104
Infections and infestations
Cellulitis
0.00%
0/102
0.96%
1/104
Infections and infestations
Gastroenteritis
0.98%
1/102
0.00%
0/104
Infections and infestations
Pneumonia
0.98%
1/102
0.00%
0/104
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/102
0.96%
1/104
Metabolism and nutrition disorders
Hypoproteinaemia
0.00%
0/102
0.96%
1/104
Musculoskeletal and connective tissue disorders
Mastication disorder
0.00%
0/102
0.96%
1/104
Musculoskeletal and connective tissue disorders
Muscle spasms
0.00%
0/102
0.96%
1/104
Musculoskeletal and connective tissue disorders
Muscular weakness
0.98%
1/102
0.96%
1/104
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
2.9%
3/102
2.9%
3/104
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric cancer
0.00%
0/102
0.96%
1/104
Nervous system disorders
Dyslalia
0.98%
1/102
1.9%
2/104
Psychiatric disorders
Anxiety
0.00%
0/102
0.96%
1/104
Psychiatric disorders
Depression
0.00%
0/102
0.96%
1/104
Respiratory, thoracic and mediastinal disorders
Aspiration
0.00%
0/102
0.96%
1/104
Respiratory, thoracic and mediastinal disorders
Dyspnoea
2.0%
2/102
0.00%
0/104
Respiratory, thoracic and mediastinal disorders
Haemoptysis
0.00%
0/102
0.96%
1/104
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/102
0.96%
1/104
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
3.9%
4/102
0.00%
0/104
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.98%
1/102
4.8%
5/104
Respiratory, thoracic and mediastinal disorders
Sputum retention
0.98%
1/102
0.00%
0/104

Other adverse events

Other adverse events
Measure
MCI-186
n=102 participants at risk
Edaravone 60 mg, intravenously infused over 60 min once daily.
Placebo of MCI-186
n=104 participants at risk
Edaravone matched placebo, intravenously infused over 60 min once daily.
Blood and lymphatic system disorders
Anaemia
0.00%
0/102
2.9%
3/104
Cardiac disorders
Palpitations
0.98%
1/102
0.00%
0/104
Cardiac disorders
Supraventricular extrasystoles
0.98%
1/102
0.00%
0/104
Ear and labyrinth disorders
Cerumen impaction
0.98%
1/102
0.00%
0/104
Ear and labyrinth disorders
Eustachian tube patulous
0.98%
1/102
0.00%
0/104
Ear and labyrinth disorders
Vertigo
0.00%
0/102
1.9%
2/104
Ear and labyrinth disorders
Vertigo positional
0.98%
1/102
0.96%
1/104
Eye disorders
Astigmatism
0.00%
0/102
0.96%
1/104
Eye disorders
Cataract
0.00%
0/102
1.9%
2/104
Eye disorders
Conjunctivitis
0.98%
1/102
0.00%
0/104
Eye disorders
Conjunctivitis allergic
0.00%
0/102
0.96%
1/104
Eye disorders
Dry eye
0.98%
1/102
0.00%
0/104
Eye disorders
Eye discharge
0.00%
0/102
0.96%
1/104
Eye disorders
Eye pain
0.98%
1/102
0.96%
1/104
Eye disorders
Eye pruritus
0.00%
0/102
0.96%
1/104
Eye disorders
Myodesopsia
0.98%
1/102
0.00%
0/104
Gastrointestinal disorders
Abdominal discomfort
0.98%
1/102
0.00%
0/104
Gastrointestinal disorders
Abdominal pain
2.0%
2/102
0.00%
0/104
Gastrointestinal disorders
Abdominal pain upper
2.0%
2/102
0.00%
0/104
Gastrointestinal disorders
Anal prolapse
0.00%
0/102
0.96%
1/104
Gastrointestinal disorders
Constipation
12.7%
13/102
16.3%
17/104
Gastrointestinal disorders
Dental caries
0.98%
1/102
0.00%
0/104
Gastrointestinal disorders
Diarrhoea
3.9%
4/102
4.8%
5/104
Gastrointestinal disorders
Dysphagia
0.00%
0/102
0.96%
1/104
Gastrointestinal disorders
Gastric ulcer
0.98%
1/102
0.00%
0/104
Gastrointestinal disorders
Gastritis
2.0%
2/102
1.9%
2/104
Gastrointestinal disorders
Gingival swelling
0.00%
0/102
0.96%
1/104
Gastrointestinal disorders
Gingivitis
0.00%
0/102
0.96%
1/104
Gastrointestinal disorders
Haemorrhoidal haemorrhage
0.00%
0/102
0.96%
1/104
Gastrointestinal disorders
Haemorrhoids
0.00%
0/102
0.96%
1/104
Gastrointestinal disorders
Inguinal hernia
0.98%
1/102
0.00%
0/104
Gastrointestinal disorders
Nausea
2.0%
2/102
0.96%
1/104
Gastrointestinal disorders
Periodontitis
0.98%
1/102
0.00%
0/104
Gastrointestinal disorders
Sensitivity of teeth
0.98%
1/102
0.00%
0/104
Gastrointestinal disorders
Stomach discomfort
0.00%
0/102
1.9%
2/104
Gastrointestinal disorders
Stomatitis
0.98%
1/102
4.8%
5/104
Gastrointestinal disorders
Tooth loss
0.98%
1/102
0.00%
0/104
Gastrointestinal disorders
Toothache
0.98%
1/102
0.00%
0/104
Gastrointestinal disorders
Vomiting
0.00%
0/102
0.96%
1/104
General disorders
Abasia
0.98%
1/102
0.00%
0/104
General disorders
Catheter site erythema
0.00%
0/102
0.96%
1/104
General disorders
Catheter site inflammation
0.00%
0/102
1.9%
2/104
General disorders
Catheter site pain
0.00%
0/102
0.96%
1/104
General disorders
Chest pain
2.0%
2/102
0.00%
0/104
General disorders
Feeling abnormal
0.98%
1/102
0.96%
1/104
General disorders
Gait disturbance
16.7%
17/102
13.5%
14/104
General disorders
Infusion site reaction
0.98%
1/102
0.00%
0/104
General disorders
Injection site phlebitis
0.00%
0/102
0.96%
1/104
General disorders
Local swelling
0.98%
1/102
0.00%
0/104
General disorders
Malaise
0.98%
1/102
0.00%
0/104
General disorders
Oedema
0.98%
1/102
0.00%
0/104
General disorders
Oedema peripheral
0.00%
0/102
2.9%
3/104
General disorders
Pyrexia
0.98%
1/102
0.96%
1/104
General disorders
Thirst
0.98%
1/102
0.00%
0/104
Hepatobiliary disorders
Hepatic function abnormal
0.98%
1/102
4.8%
5/104
Hepatobiliary disorders
Hepatic steatosis
2.0%
2/102
0.00%
0/104
Hepatobiliary disorders
Liver disorder
2.0%
2/102
0.00%
0/104
Immune system disorders
Seasonal allergy
0.00%
0/102
0.96%
1/104
Infections and infestations
Bronchitis
2.0%
2/102
2.9%
3/104
Infections and infestations
Cystitis
2.0%
2/102
1.9%
2/104
Infections and infestations
Enterocolitis bacterial
0.00%
0/102
0.96%
1/104
Infections and infestations
Folliculitis
0.00%
0/102
0.96%
1/104
Infections and infestations
Gastroenteritis
0.00%
0/102
2.9%
3/104
Infections and infestations
Herpes zoster
0.98%
1/102
0.96%
1/104
Infections and infestations
Influenza
2.9%
3/102
1.9%
2/104
Infections and infestations
Nail infection
0.98%
1/102
0.00%
0/104
Infections and infestations
Nasopharyngitis
21.6%
22/102
21.2%
22/104
Infections and infestations
Onychomycosis
0.98%
1/102
0.00%
0/104
Infections and infestations
Oral herpes
0.98%
1/102
0.00%
0/104
Infections and infestations
Otitis externa
0.00%
0/102
0.96%
1/104
Infections and infestations
Otitis media
0.98%
1/102
0.96%
1/104
Infections and infestations
Pharyngitis
2.9%
3/102
1.9%
2/104
Infections and infestations
Pneumonia
0.00%
0/102
0.96%
1/104
Infections and infestations
Purulence
0.98%
1/102
0.00%
0/104
Infections and infestations
Rhinitis
0.00%
0/102
0.96%
1/104
Infections and infestations
Tinea capitis
0.00%
0/102
0.96%
1/104
Infections and infestations
Tinea cruris
0.00%
0/102
0.96%
1/104
Infections and infestations
Tinea infection
0.98%
1/102
0.00%
0/104
Infections and infestations
Tinea pedis
2.0%
2/102
0.96%
1/104
Infections and infestations
Tonsillitis
0.00%
0/102
0.96%
1/104
Infections and infestations
Tooth abscess
0.98%
1/102
0.00%
0/104
Injury, poisoning and procedural complications
Arthropod sting
0.98%
1/102
1.9%
2/104
Injury, poisoning and procedural complications
Back injury
0.98%
1/102
0.96%
1/104
Injury, poisoning and procedural complications
Clavicle fracture
0.00%
0/102
0.96%
1/104
Injury, poisoning and procedural complications
Contusion
11.8%
12/102
4.8%
5/104
Injury, poisoning and procedural complications
Excoriation
2.9%
3/102
0.96%
1/104
Injury, poisoning and procedural complications
Foot fracture
0.00%
0/102
0.96%
1/104
Injury, poisoning and procedural complications
Joint dislocation
0.98%
1/102
0.96%
1/104
Injury, poisoning and procedural complications
Joint sprain
2.9%
3/102
0.00%
0/104
Injury, poisoning and procedural complications
Open wound
0.98%
1/102
0.96%
1/104
Injury, poisoning and procedural complications
Periorbital haematoma
0.00%
0/102
0.96%
1/104
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/102
0.96%
1/104
Injury, poisoning and procedural complications
Skeletal injury
0.00%
0/102
0.96%
1/104
Injury, poisoning and procedural complications
Skin laceration
0.98%
1/102
1.9%
2/104
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/102
0.96%
1/104
Injury, poisoning and procedural complications
Subdural haematoma
0.00%
0/102
0.96%
1/104
Injury, poisoning and procedural complications
Thermal burn
0.00%
0/102
0.96%
1/104
Injury, poisoning and procedural complications
Tooth fracture
0.00%
0/102
1.9%
2/104
Investigations
Alanine aminotransferase increased
0.00%
0/102
0.96%
1/104
Investigations
Aspartate aminotransferase increased
0.00%
0/102
0.96%
1/104
Investigations
Blood alkaline phosphatase increased
0.00%
0/102
0.96%
1/104
Investigations
Blood creatine phosphokinase increased
0.98%
1/102
0.00%
0/104
Investigations
Blood pressure increased
0.00%
0/102
0.96%
1/104
Investigations
Blood urea increased
0.98%
1/102
0.00%
0/104
Investigations
Blood urine present
0.00%
0/102
0.96%
1/104
Investigations
Gamma-glutamyltransferase increased
0.98%
1/102
0.00%
0/104
Investigations
Glucose urine present
5.9%
6/102
2.9%
3/104
Investigations
Liver function test abnormal
0.98%
1/102
0.00%
0/104
Investigations
Protein urine present
0.00%
0/102
0.96%
1/104
Investigations
White blood cell count decreased
0.00%
0/102
1.9%
2/104
Musculoskeletal and connective tissue disorders
Arthralgia
2.0%
2/102
0.96%
1/104
Musculoskeletal and connective tissue disorders
Back pain
2.9%
3/102
4.8%
5/104
Musculoskeletal and connective tissue disorders
Bursitis
0.00%
0/102
0.96%
1/104
Musculoskeletal and connective tissue disorders
Dupuytren's contracture
0.98%
1/102
0.00%
0/104
Musculoskeletal and connective tissue disorders
Limb discomfort
0.98%
1/102
0.00%
0/104
Musculoskeletal and connective tissue disorders
Muscular weakness
5.9%
6/102
7.7%
8/104
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
2.0%
2/102
2.9%
3/104
Musculoskeletal and connective tissue disorders
Neck pain
2.0%
2/102
0.00%
0/104
Musculoskeletal and connective tissue disorders
Osteoarthritis
0.98%
1/102
0.96%
1/104
Musculoskeletal and connective tissue disorders
Osteoporosis
0.98%
1/102
0.00%
0/104
Musculoskeletal and connective tissue disorders
Periarthritis
0.00%
0/102
0.96%
1/104
Musculoskeletal and connective tissue disorders
Spinal column stenosis
0.00%
0/102
1.9%
2/104
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
0.98%
1/102
0.00%
0/104
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
0.98%
1/102
0.00%
0/104
Nervous system disorders
Dizziness
0.98%
1/102
1.9%
2/104
Nervous system disorders
Dizziness postural
0.00%
0/102
0.96%
1/104
Nervous system disorders
Headache
7.8%
8/102
2.9%
3/104
Nervous system disorders
Intercostal neuralgia
0.98%
1/102
0.00%
0/104
Nervous system disorders
Migraine
0.98%
1/102
0.00%
0/104
Nervous system disorders
Pallanaesthesia
0.00%
0/102
0.96%
1/104
Nervous system disorders
Post herpetic neuralgia
0.98%
1/102
0.00%
0/104
Nervous system disorders
Sensory disturbance
0.00%
0/102
0.96%
1/104
Nervous system disorders
Tension headache
2.0%
2/102
0.00%
0/104
Psychiatric disorders
Anxiety
0.00%
0/102
0.96%
1/104
Psychiatric disorders
Insomnia
8.8%
9/102
9.6%
10/104
Renal and urinary disorders
Calculus urinary
0.98%
1/102
0.00%
0/104
Renal and urinary disorders
Dysuria
0.00%
0/102
0.96%
1/104
Renal and urinary disorders
Nocturia
0.00%
0/102
0.96%
1/104
Renal and urinary disorders
Pollakiuria
0.98%
1/102
0.00%
0/104
Renal and urinary disorders
Proteinuria
0.00%
0/102
0.96%
1/104
Reproductive system and breast disorders
Benign prostatic hyperplasia
0.98%
1/102
0.00%
0/104
Reproductive system and breast disorders
Epididymitis
0.00%
0/102
0.96%
1/104
Reproductive system and breast disorders
Gynaecomastia
0.98%
1/102
0.00%
0/104
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/102
0.96%
1/104
Respiratory, thoracic and mediastinal disorders
Cough
0.98%
1/102
1.9%
2/104
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/102
0.96%
1/104
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.98%
1/102
0.00%
0/104
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
0.98%
1/102
0.96%
1/104
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/102
0.96%
1/104
Respiratory, thoracic and mediastinal disorders
Sputum retention
0.00%
0/102
0.96%
1/104
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
0.98%
1/102
1.9%
2/104
Skin and subcutaneous tissue disorders
Acrodermatitis
0.00%
0/102
0.96%
1/104
Skin and subcutaneous tissue disorders
Blister
0.98%
1/102
0.00%
0/104
Skin and subcutaneous tissue disorders
Dermal cyst
0.98%
1/102
0.00%
0/104
Skin and subcutaneous tissue disorders
Dermatitis
0.98%
1/102
0.00%
0/104
Skin and subcutaneous tissue disorders
Dermatitis contact
2.9%
3/102
1.9%
2/104
Skin and subcutaneous tissue disorders
Drug eruption
0.00%
0/102
0.96%
1/104
Skin and subcutaneous tissue disorders
Eczema
6.9%
7/102
1.9%
2/104
Skin and subcutaneous tissue disorders
Eczema asteatotic
0.00%
0/102
2.9%
3/104
Skin and subcutaneous tissue disorders
Erythema
2.9%
3/102
1.9%
2/104
Skin and subcutaneous tissue disorders
Excessive granulation tissue
0.98%
1/102
0.00%
0/104
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
0.00%
0/102
1.9%
2/104
Skin and subcutaneous tissue disorders
Hidradenitis
0.98%
1/102
0.00%
0/104
Skin and subcutaneous tissue disorders
Pruritus
0.98%
1/102
2.9%
3/104
Skin and subcutaneous tissue disorders
Purpura
0.98%
1/102
0.96%
1/104
Skin and subcutaneous tissue disorders
Rash
3.9%
4/102
1.9%
2/104
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/102
0.96%
1/104
Skin and subcutaneous tissue disorders
Skin exfoliation
0.98%
1/102
0.00%
0/104
Skin and subcutaneous tissue disorders
Toxic skin eruption
0.98%
1/102
0.00%
0/104
Skin and subcutaneous tissue disorders
Urticaria
0.98%
1/102
0.96%
1/104
Skin and subcutaneous tissue disorders
Xeroderma
0.98%
1/102
0.00%
0/104
Vascular disorders
Essential hypertension
0.98%
1/102
0.00%
0/104
Vascular disorders
Haematoma
0.98%
1/102
0.00%
0/104
Vascular disorders
Hypertension
2.0%
2/102
1.9%
2/104
Vascular disorders
Phlebitis
0.00%
0/102
0.96%
1/104
Metabolism and nutrition disorders
Anorexia
0.98%
1/102
0.00%
0/104
Metabolism and nutrition disorders
Dehydration
0.98%
1/102
0.00%
0/104
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/102
0.96%
1/104
Metabolism and nutrition disorders
Hyperlipidaemia
0.00%
0/102
0.96%
1/104
Metabolism and nutrition disorders
Type 2 diabetes mellitus
0.98%
1/102
0.00%
0/104

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER