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Trial Outcomes & Findings for Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis (NCT NCT01492686)

NCT ID: NCT01492686

Last Updated: 2018-12-31

Results Overview

0=worst; 48=best

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

137 participants

Primary outcome timeframe

baseline and 24 weeks

Results posted on

2018-12-31

Participant Flow

Participant milestones

Participant milestones
Measure
MCI-186
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Double-blind Phase
STARTED
69
68
Double-blind Phase
COMPLETED
67
60
Double-blind Phase
NOT COMPLETED
2
8
Open-label Phase
STARTED
65
58
Open-label Phase
COMPLETED
53
40
Open-label Phase
NOT COMPLETED
12
18

Reasons for withdrawal

Reasons for withdrawal
Measure
MCI-186
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Double-blind Phase
Adverse Event
0
2
Double-blind Phase
Physician Decision
0
1
Double-blind Phase
Withdrawal by Subject
0
2
Double-blind Phase
Due to a discontinuation criterion
2
3
Open-label Phase
Adverse Event
1
2
Open-label Phase
Physician Decision
1
0
Open-label Phase
Withdrawal by Subject
6
7
Open-label Phase
Due to a discontinuation criterion
4
9

Baseline Characteristics

Phase 3 Study of MCI-186 for Treatment of Amyotrophic Lateral Sclerosis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
MCI-186
n=69 Participants
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
n=68 Participants
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Total
n=137 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
46 Participants
n=5 Participants
46 Participants
n=7 Participants
92 Participants
n=5 Participants
Age, Categorical
>=65 years
23 Participants
n=5 Participants
22 Participants
n=7 Participants
45 Participants
n=5 Participants
Sex: Female, Male
Female
31 Participants
n=5 Participants
27 Participants
n=7 Participants
58 Participants
n=5 Participants
Sex: Female, Male
Male
38 Participants
n=5 Participants
41 Participants
n=7 Participants
79 Participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline and 24 weeks

Population: "1 patient who did not reach the end of cycle 3" was excluded from the FAS in the MCI-186 group. "2 patients who did not reach the end of cycle 3" were excluded from the FAS in the Placebo of MCI-186 group.

0=worst; 48=best

Outcome measures

Outcome measures
Measure
MCI-186
n=68 Participants
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
n=66 Participants
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Change From Baseline in Revised ALS Functional Rating Scale (ALSFRS-R) Score in Full Analysis Set (FAS) Population at 24 Weeks
-5.01 units on a scale
Standard Error 0.64
-7.5 units on a scale
Standard Error 0.66

SECONDARY outcome

Timeframe: 24 weeks

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

Outcome measures

Outcome measures
Measure
MCI-186
n=69 Participants
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
n=68 Participants
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Number of Participants With Death or a Specified State of Disease Progression
Death
0 Count of Participants
0 Count of Participants
Number of Participants With Death or a Specified State of Disease Progression
Disability of independent ambulation
0 Count of Participants
2 Count of Participants
Number of Participants With Death or a Specified State of Disease Progression
Loss of upper limbs function
0 Count of Participants
0 Count of Participants
Number of Participants With Death or a Specified State of Disease Progression
Tracheotomy
1 Count of Participants
0 Count of Participants
Number of Participants With Death or a Specified State of Disease Progression
Use of respirator
0 Count of Participants
0 Count of Participants
Number of Participants With Death or a Specified State of Disease Progression
Use of tube feeding
0 Count of Participants
1 Count of Participants
Number of Participants With Death or a Specified State of Disease Progression
Loss of useful speech
1 Count of Participants
3 Count of Participants

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: "1 patient who did not reach the end of cycle 3" and "1 patient with missing data" were excluded from the FAS in the MCI-186 group. "2 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=67 Participants
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
n=66 Participants
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Change From Baseline in % Forced Vital Capacity (%FVC) in Full Analysis Set (FAS) Population at 24 Weeks
-15.61 percentage of FVC
Standard Error 2.41
-20.4 percentage of FVC
Standard Error 2.48

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: "1 patient who did not reach the end of cycle 3" was excluded from the FAS in the MCI-186 group. "2 patients who did not reach the end of cycle 3" and "3 patient 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. 0=worst; 102=best

Outcome measures

Outcome measures
Measure
MCI-186
n=68 Participants
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
n=63 Participants
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Change From Baseline in Modified Norris Scale Score in Full Analysis Set (FAS) Population at 24 Weeks
-15.91 units on a scale
Standard Error 1.97
-20.8 units on a scale
Standard Error 2.06

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: "1 patient who did not reach the end of cycle 3" was excluded from the FAS in the MCI-186 group. "2 patients who did not reach the end of cycle 3" and "2 patient 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, Activities of daily living (ADL) and independence, eating and drinking, communication, and emotional reactions. 200=worst; 40=best

Outcome measures

Outcome measures
Measure
MCI-186
n=68 Participants
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
n=64 Participants
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Change From Baseline in ALS Assessment Questionnaire (40 Items) (ALSAQ40) in Full Analysis Set (FAS) Population at 24 Weeks
17.25 units on a scale
Standard Error 3.39
26.04 units on a scale
Standard Error 3.53

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure
MCI-186
n=69 Participants
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
n=68 Participants
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Percentage of Participants With Adverse Events
84.1 percentage of Participants
83.8 percentage of Participants

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure
MCI-186
n=69 Participants
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
n=68 Participants
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Percentage of Participants With Adverse Drug Reactions
2.9 percentage of Participants
7.4 percentage of Participants

SECONDARY outcome

Timeframe: 24 weeks

Outcome measures

Outcome measures
Measure
MCI-186
n=69 Participants
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
n=68 Participants
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0)
Blood bilirubin increased
0 percentage of Participants
1.5 percentage of Participants
Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0)
Blood creatine phosphokinase increased
0 percentage of Participants
1.5 percentage of Participants
Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0)
Liver function test abnormal
1.4 percentage of Participants
1.5 percentage of Participants
Laboratory Tests Percentage of Participants With Adverse Events by System Organ Class (SOC) of "Investigations" (PT, MedDRA Ver. 17.0)
White blood cell count decreased
1.4 percentage of Participants
0 percentage of Participants

SECONDARY outcome

Timeframe: baseline and 24 weeks

Population: A note: Four patients of Placebo of MCI-186 group did not have data at 24 week. Therefore, concerning numbness (at 24 week) and staggering (at 24 week), the number of participants analysed are 64 in the both groups.

Outcome measures

Outcome measures
Measure
MCI-186
n=69 Participants
Double-blind MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Placebo of MCI-186
n=68 Participants
Double-blind Placebo of MCI-186, Then Open-label MCI-186. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Percentage of Participants With Abnormal Values in Sensory Examinations
Numbness (at 24 week)
7.2 percentage of Participants
9.4 percentage of Participants
Percentage of Participants With Abnormal Values in Sensory Examinations
Numbness (at baseline)
2.9 percentage of Participants
7.4 percentage of Participants
Percentage of Participants With Abnormal Values in Sensory Examinations
Staggering (at baseline)
1.4 percentage of Participants
8.8 percentage of Participants
Percentage of Participants With Abnormal Values in Sensory Examinations
Staggering (at 24 week)
2.9 percentage of Participants
3.1 percentage of Participants

Adverse Events

Double-blind MCI-186

Serious events: 11 serious events
Other events: 57 other events
Deaths: 0 deaths

Double-blind Placebo of MCI-186

Serious events: 16 serious events
Other events: 51 other events
Deaths: 0 deaths

Open-label MCI-186 (Double-blind MCI-186, Then Open-label)

Serious events: 17 serious events
Other events: 53 other events
Deaths: 0 deaths

Open-label MCI-186 (Double-blind Placebo, Then Open-label)

Serious events: 23 serious events
Other events: 48 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Double-blind MCI-186
n=69 participants at risk
MCI-186 in Double-blind. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186
n=68 participants at risk
Placebo of MCI-186 in Double-blind. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Open-label MCI-186 (Double-blind MCI-186, Then Open-label)
n=65 participants at risk
MCI-186 in Open-label (Double-blind MCI-186, Then Open-label). 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Open-label MCI-186 (Double-blind Placebo, Then Open-label)
n=58 participants at risk
MCI-186 in Open-label (Double-blind Placebo of MCI-186, Then Open-label). 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Gastrointestinal disorders
Dysphagia
11.6%
8/69
11.8%
8/68
9.2%
6/65
22.4%
13/58
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/69
1.5%
1/68
0.00%
0/65
1.7%
1/58
Hepatobiliary disorders
Drug-induced liver injury
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Bacterial infection
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Injury, poisoning and procedural complications
Contusion
0.00%
0/69
1.5%
1/68
0.00%
0/65
1.7%
1/58
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
0.00%
0/69
1.5%
1/68
4.6%
3/65
3.4%
2/58
Nervous system disorders
Speech disorder
1.4%
1/69
2.9%
2/68
3.1%
2/65
1.7%
1/58
Psychiatric disorders
Depression
0.00%
0/69
1.5%
1/68
0.00%
0/65
1.7%
1/58
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/69
1.5%
1/68
1.5%
1/65
1.7%
1/58
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/69
2.9%
2/68
3.1%
2/65
5.2%
3/58
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
2.9%
2/69
2.9%
2/68
6.2%
4/65
6.9%
4/58
Infections and infestations
Bronchitis
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Psychiatric disorders
Adjustment disorder
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Cardiac disorders
Stress cardiomyopathy
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Vascular disorders
Shock
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/69
0.00%
0/68
1.5%
1/65
5.2%
3/58
Hepatobiliary disorders
Cholecystitis
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
General disorders
Gait disturbance
0.00%
0/69
0.00%
0/68
3.1%
2/65
0.00%
0/58

Other adverse events

Other adverse events
Measure
Double-blind MCI-186
n=69 participants at risk
MCI-186 in Double-blind. 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Double-blind Placebo of MCI-186
n=68 participants at risk
Placebo of MCI-186 in Double-blind. 2 ampoules of edaravone injection placebo were administered once daily over 60 min by intravenous infusion.
Open-label MCI-186 (Double-blind MCI-186, Then Open-label)
n=65 participants at risk
MCI-186 in Open-label (Double-blind MCI-186, Then Open-label). 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Open-label MCI-186 (Double-blind Placebo, Then Open-label)
n=58 participants at risk
MCI-186 in Open-label (Double-blind Placebo of MCI-186, Then Open-label). 2 ampoules of edaravone injection 30 mg were administered once daily over 60 min by intravenous infusion.
Gastrointestinal disorders
Malocclusion
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Gastrointestinal disorders
Nausea
2.9%
2/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Gastrointestinal disorders
Periodontal disease
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Gastrointestinal disorders
Stomatitis
1.4%
1/69
0.00%
0/68
0.00%
0/65
3.4%
2/58
Blood and lymphatic system disorders
Anaemia
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Ear and labyrinth disorders
Deafness neurosensory
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Ear and labyrinth disorders
Vertigo
0.00%
0/69
1.5%
1/68
1.5%
1/65
0.00%
0/58
Ear and labyrinth disorders
Vertigo positional
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Eye disorders
Blepharitis
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Eye disorders
Eye discharge
1.4%
1/69
1.5%
1/68
3.1%
2/65
0.00%
0/58
Eye disorders
Retinal tear
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Gastrointestinal disorders
Abdominal discomfort
2.9%
2/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Gastrointestinal disorders
Cheilitis
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Gastrointestinal disorders
Constipation
11.6%
8/69
11.8%
8/68
10.8%
7/65
13.8%
8/58
Gastrointestinal disorders
Diarrhoea
2.9%
2/69
5.9%
4/68
3.1%
2/65
3.4%
2/58
Gastrointestinal disorders
Dysphagia
0.00%
0/69
2.9%
2/68
9.2%
6/65
22.4%
13/58
Gastrointestinal disorders
Gastritis
1.4%
1/69
0.00%
0/68
4.6%
3/65
0.00%
0/58
Gastrointestinal disorders
Haemorrhoids
1.4%
1/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
General disorders
Catheter site dermatitis
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
General disorders
Feeling hot
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
General disorders
Infusion site erythema
4.3%
3/69
2.9%
2/68
3.1%
2/65
1.7%
1/58
General disorders
Infusion site pain
4.3%
3/69
2.9%
2/68
0.00%
0/65
1.7%
1/58
General disorders
Infusion site phlebitis
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
General disorders
Infusion site swelling
0.00%
0/69
2.9%
2/68
1.5%
1/65
0.00%
0/58
General disorders
Injection site rash
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
General disorders
Injection site reaction
0.00%
0/69
2.9%
2/68
0.00%
0/65
3.4%
2/58
General disorders
Pain
0.00%
0/69
1.5%
1/68
1.5%
1/65
3.4%
2/58
General disorders
Pyrexia
0.00%
0/69
4.4%
3/68
1.5%
1/65
0.00%
0/58
General disorders
Swelling
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Hepatobiliary disorders
Hepatic function abnormal
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Cellulitis
2.9%
2/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Infections and infestations
Chronic sinusitis
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Conjunctivitis
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Dermatitis infected
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Device related infection
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Gastroenteritis
1.4%
1/69
1.5%
1/68
3.1%
2/65
0.00%
0/58
Infections and infestations
Gingival abscess
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Herpes zoster
1.4%
1/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Infections and infestations
Infected dermal cyst
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Nasopharyngitis
4.3%
3/69
7.4%
5/68
9.2%
6/65
6.9%
4/58
Infections and infestations
Oral herpes
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Otitis externa
0.00%
0/69
1.5%
1/68
0.00%
0/65
1.7%
1/58
Infections and infestations
Periodontitis
1.4%
1/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Infections and infestations
Pharyngitis
2.9%
2/69
2.9%
2/68
1.5%
1/65
1.7%
1/58
Infections and infestations
Postoperative wound infection
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Tinea infection
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Tinea pedis
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Upper respiratory tract infection
2.9%
2/69
1.5%
1/68
1.5%
1/65
0.00%
0/58
Injury, poisoning and procedural complications
Arthropod bite
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Injury, poisoning and procedural complications
Chillblains
0.00%
0/69
1.5%
1/68
0.00%
0/65
3.4%
2/58
Injury, poisoning and procedural complications
Contusion
18.8%
13/69
11.8%
8/68
9.2%
6/65
10.3%
6/58
Injury, poisoning and procedural complications
Excoriation
2.9%
2/69
2.9%
2/68
4.6%
3/65
0.00%
0/58
Injury, poisoning and procedural complications
Foot fracture
0.00%
0/69
1.5%
1/68
1.5%
1/65
0.00%
0/58
Injury, poisoning and procedural complications
Injury
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Injury, poisoning and procedural complications
Laceration
1.4%
1/69
2.9%
2/68
1.5%
1/65
1.7%
1/58
Injury, poisoning and procedural complications
Ligament sprain
2.9%
2/69
2.9%
2/68
1.5%
1/65
3.4%
2/58
Injury, poisoning and procedural complications
Lip injury
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Injury, poisoning and procedural complications
Procedural pain
2.9%
2/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Injury, poisoning and procedural complications
Radius fracture
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Injury, poisoning and procedural complications
Spinal compression fracture
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Injury, poisoning and procedural complications
Wound
0.00%
0/69
1.5%
1/68
6.2%
4/65
3.4%
2/58
Investigations
Blood bilirubin increased
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Investigations
Blood creatine phosphokinase increased
0.00%
0/69
1.5%
1/68
1.5%
1/65
0.00%
0/58
Investigations
Liver function test abnormal
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Investigations
White blood cell count decreased
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Metabolism and nutrition disorders
Gout
0.00%
0/69
2.9%
2/68
0.00%
0/65
0.00%
0/58
Metabolism and nutrition disorders
Hyperlipidaemia
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Musculoskeletal and connective tissue disorders
Arthralgia
1.4%
1/69
2.9%
2/68
6.2%
4/65
1.7%
1/58
Musculoskeletal and connective tissue disorders
Arthritis
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Musculoskeletal and connective tissue disorders
Back pain
5.8%
4/69
1.5%
1/68
3.1%
2/65
0.00%
0/58
Musculoskeletal and connective tissue disorders
Bursitis
1.4%
1/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/69
1.5%
1/68
0.00%
0/65
3.4%
2/58
Musculoskeletal and connective tissue disorders
Myalgia
5.8%
4/69
1.5%
1/68
0.00%
0/65
1.7%
1/58
Musculoskeletal and connective tissue disorders
Myofascial pain syndrome
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Musculoskeletal and connective tissue disorders
Neck pain
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Musculoskeletal and connective tissue disorders
Pain in extremity
2.9%
2/69
1.5%
1/68
1.5%
1/65
1.7%
1/58
Musculoskeletal and connective tissue disorders
Periarthritis
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Nervous system disorders
Carpal tunnel syndrome
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Nervous system disorders
Decreased vibratory sense
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Nervous system disorders
Dizziness
2.9%
2/69
2.9%
2/68
0.00%
0/65
0.00%
0/58
Nervous system disorders
Dysgeusia
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Nervous system disorders
Headache
5.8%
4/69
7.4%
5/68
1.5%
1/65
5.2%
3/58
Nervous system disorders
Hypoaesthesia
1.4%
1/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Nervous system disorders
Sciatica
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Psychiatric disorders
Insomnia
7.2%
5/69
5.9%
4/68
3.1%
2/65
3.4%
2/58
Renal and urinary disorders
Dysuria
1.4%
1/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Renal and urinary disorders
Pollakiuria
0.00%
0/69
2.9%
2/68
3.1%
2/65
1.7%
1/58
Respiratory, thoracic and mediastinal disorders
Cough
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Respiratory, thoracic and mediastinal disorders
Nasal congestion
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
1.4%
1/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
1.4%
1/69
0.00%
0/68
6.2%
4/65
6.9%
4/58
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
7.2%
5/69
2.9%
2/68
6.2%
4/65
1.7%
1/58
Skin and subcutaneous tissue disorders
Asteatosis
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Blister
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Decubitus ulcer
1.4%
1/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Dermatitis contact
11.6%
8/69
4.4%
3/68
4.6%
3/65
1.7%
1/58
Skin and subcutaneous tissue disorders
Dry skin
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Eczema
7.2%
5/69
2.9%
2/68
7.7%
5/65
3.4%
2/58
Skin and subcutaneous tissue disorders
Erythema
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Haemorrhage subcutaneous
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Henoch-Schonlein purpura
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Hyperkeratosis
1.4%
1/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Miliaria
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Pruritus
0.00%
0/69
4.4%
3/68
7.7%
5/65
1.7%
1/58
Skin and subcutaneous tissue disorders
Rash
1.4%
1/69
2.9%
2/68
1.5%
1/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Skin exfoliation
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Skin lesion
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Skin ulcer
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Urticaria
1.4%
1/69
0.00%
0/68
1.5%
1/65
1.7%
1/58
Vascular disorders
Hypertension
1.4%
1/69
0.00%
0/68
1.5%
1/65
1.7%
1/58
Vascular disorders
Hypotension
0.00%
0/69
1.5%
1/68
0.00%
0/65
0.00%
0/58
Vascular disorders
Phlebitis
0.00%
0/69
2.9%
2/68
0.00%
0/65
0.00%
0/58
Vascular disorders
Vasculitis
1.4%
1/69
0.00%
0/68
0.00%
0/65
0.00%
0/58
Infections and infestations
Bronchitis
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Infections and infestations
Gingivitis
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Infections and infestations
Herpes simplex
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Infections and infestations
Influenza
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Infections and infestations
Oral candidiasis
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Infections and infestations
Tinea cruris
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Infections and infestations
Catheter site infection
0.00%
0/69
0.00%
0/68
3.1%
2/65
0.00%
0/58
Immune system disorders
Seasonal allergy
0.00%
0/69
0.00%
0/68
1.5%
1/65
1.7%
1/58
Psychiatric disorders
Anxiety
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Psychiatric disorders
Depression
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Psychiatric disorders
Neurosis
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Psychiatric disorders
Adjustment disorder
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Nervous system disorders
Speech disorder
0.00%
0/69
0.00%
0/68
3.1%
2/65
1.7%
1/58
Nervous system disorders
Tremor
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Eye disorders
Conjunctivitis allergic
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Eye disorders
Diplopia
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Eye disorders
Dry eye
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Eye disorders
Eczema eyelids
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Ear and labyrinth disorders
Sudden hearing loss
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Cardiac disorders
Arrhythmia
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Cardiac disorders
Tachycardia
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Cardiac disorders
Stress cardiomyopathy
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Vascular disorders
Shock
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Respiratory, thoracic and mediastinal disorders
Asthma
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/69
0.00%
0/68
1.5%
1/65
1.7%
1/58
Respiratory, thoracic and mediastinal disorders
Epistaxis
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
0.00%
0/69
0.00%
0/68
3.1%
2/65
5.2%
3/58
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.00%
0/69
0.00%
0/68
1.5%
1/65
5.2%
3/58
Gastrointestinal disorders
Change of bowel habit
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Gastrointestinal disorders
Dental caries
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Gastrointestinal disorders
Dyspepsia
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Gastrointestinal disorders
Gastric ulcer
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Gastrointestinal disorders
Anal inflammation
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Gastrointestinal disorders
Epigastric discomfort
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Hepatobiliary disorders
Cholecystitis
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Acne
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Dermatitis
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Eczema asteatotic
0.00%
0/69
0.00%
0/68
3.1%
2/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
0.00%
0/69
0.00%
0/68
0.00%
0/65
3.4%
2/58
Skin and subcutaneous tissue disorders
Toxic skin eruption
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Skin and subcutaneous tissue disorders
Excessive granulation tissue
0.00%
0/69
0.00%
0/68
1.5%
1/65
3.4%
2/58
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
0.00%
0/69
0.00%
0/68
4.6%
3/65
3.4%
2/58
Musculoskeletal and connective tissue disorders
Tendon pain
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Renal and urinary disorders
Haematuria
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Renal and urinary disorders
Incontinence
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Renal and urinary disorders
Nocturia
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
General disorders
Gait disturbance
0.00%
0/69
0.00%
0/68
3.1%
2/65
0.00%
0/58
General disorders
Malaise
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
General disorders
Catheter site haemorrhage
0.00%
0/69
0.00%
0/68
1.5%
1/65
1.7%
1/58
General disorders
Catheter site erythema
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
General disorders
Catheter site inflammation
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
General disorders
Infusion site pruritus
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
General disorders
Puncture site swelling
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Investigations
Blood pressure increased
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Investigations
Gamma-glutamyltransferase increased
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Investigations
Blood urine present
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Investigations
White blood cell count increased
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Investigations
Protein urine present
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Injury, poisoning and procedural complications
Bite
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Injury, poisoning and procedural complications
Head injury
0.00%
0/69
0.00%
0/68
0.00%
0/65
1.7%
1/58
Injury, poisoning and procedural complications
Rib fracture
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Injury, poisoning and procedural complications
Wound compliation
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58
Injury, poisoning and procedural complications
Tooth fracture
0.00%
0/69
0.00%
0/68
1.5%
1/65
0.00%
0/58

Additional Information

Clinical Trials, Information Desk

Mitsubishi Tanabe Pharma Corporation

Results disclosure agreements

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

Restriction type: OTHER