Trial Outcomes & Findings for An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia (NCT NCT00702754)
NCT ID: NCT00702754
Last Updated: 2019-05-10
Results Overview
7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
502 participants
Primary outcome timeframe
Session 1 - Time 0, 4 weeks post-injection compared to baseline
Results posted on
2019-05-10
Participant Flow
Approximately 500 subjects were recruited from 36 centers in North America.
Subjects had to be Botulinum Toxin Type B naive and could not have received a Botulinum Toxin Type A treatment within 12 weeks of enrollment.
Participant milestones
| Measure |
MYOBLOC Open Label Treatment
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
MYOBLOC Treatment Session 1 (Time 0)
STARTED
|
502
|
|
MYOBLOC Treatment Session 1 (Time 0)
COMPLETED
|
495
|
|
MYOBLOC Treatment Session 1 (Time 0)
NOT COMPLETED
|
7
|
|
MYOBLOC Treatment Session 2 (App 12 Wks)
STARTED
|
495
|
|
MYOBLOC Treatment Session 2 (App 12 Wks)
COMPLETED
|
475
|
|
MYOBLOC Treatment Session 2 (App 12 Wks)
NOT COMPLETED
|
20
|
|
MYOBLOC Treatment Session 3 (App 24 Wks)
STARTED
|
475
|
|
MYOBLOC Treatment Session 3 (App 24 Wks)
COMPLETED
|
450
|
|
MYOBLOC Treatment Session 3 (App 24 Wks)
NOT COMPLETED
|
25
|
|
MYOBLOC Treatment Session 4 (App 36 Wks)
STARTED
|
450
|
|
MYOBLOC Treatment Session 4 (App 36 Wks)
COMPLETED
|
428
|
|
MYOBLOC Treatment Session 4 (App 36 Wks)
NOT COMPLETED
|
22
|
|
MYOBLOC Treatment Session 5 (App 48 Wks)
STARTED
|
428
|
|
MYOBLOC Treatment Session 5 (App 48 Wks)
COMPLETED
|
396
|
|
MYOBLOC Treatment Session 5 (App 48 Wks)
NOT COMPLETED
|
32
|
|
MYOBLOC Treatment Session 6 (App 60 Wks)
STARTED
|
396
|
|
MYOBLOC Treatment Session 6 (App 60 Wks)
COMPLETED
|
377
|
|
MYOBLOC Treatment Session 6 (App 60 Wks)
NOT COMPLETED
|
19
|
|
MYOBLOC Treatment Session 7 (App 72 Wks)
STARTED
|
377
|
|
MYOBLOC Treatment Session 7 (App 72 Wks)
COMPLETED
|
353
|
|
MYOBLOC Treatment Session 7 (App 72 Wks)
NOT COMPLETED
|
24
|
|
MYOBLOC Treatment Session 8 (App 84 Wks)
STARTED
|
353
|
|
MYOBLOC Treatment Session 8 (App 84 Wks)
COMPLETED
|
329
|
|
MYOBLOC Treatment Session 8 (App 84 Wks)
NOT COMPLETED
|
24
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Open Label Safety and Immunogenicity Study of MYOBLOC (Neurobloc; Botulinum Toxin Type B) Injectable Solution in Patients With Cervical Dystonia
Baseline characteristics by cohort
| Measure |
MYOBLOC Open Label Treatment
n=502 Participants
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
419 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
83 Participants
n=93 Participants
|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 11 • n=93 Participants
|
|
Sex: Female, Male
Female
|
341 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
161 Participants
n=93 Participants
|
|
Region of Enrollment
North America
|
502 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Session 1 - Time 0, 4 weeks post-injection compared to baselinePopulation: Safety Population/Intent to Treat
7 point rating scale (-3 = significantly worse, 0 = no change, +3 = significantly better. Comparison at Wk 4 to baseline. Rating of Cervical Dystonia Symptoms
Outcome measures
| Measure |
MYOBLOC Open Label Treatment
n=495 Participants
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Treatment Assessment Scale (TAS), 4 Wks Post-injection Compared to Baseline (Time 0), Rating of Cervical Dystonia Symptoms
|
0.9 points on a scale
Standard Error 0.1 • Interval -3.0 to 3.0
|
SECONDARY outcome
Timeframe: Session 2 (12 wks) - 4 weeks post-injection compared to baselinePopulation: safety population/Intent to Treat
7 point rating scale (-3=significantly worse, 0=no change, +3=significantly better), comparison of Wk 12 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Outcome measures
| Measure |
MYOBLOC Open Label Treatment
n=475 Participants
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Treatment Assessment Scale (TAS), Approx Wk 12 + 4 Wks Post-Injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
|
1.3 points on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Session 3 (24 Wks) - 4 weeks post-injection compared to baselinePopulation: safety population/Intent to Treat
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 24 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Outcome measures
| Measure |
MYOBLOC Open Label Treatment
n=450 Participants
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Treatment Assessment Scale (TAS), Approx Wk 24 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
|
1.5 points on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Session 4 (36 Wks) - 4 weeks post-injection compared to baselinePopulation: safety population/Intent to Treat
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 36 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Outcome measures
| Measure |
MYOBLOC Open Label Treatment
n=428 Participants
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Treatment Assessment Scale (TAS), Approx Wk 36 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
|
1.4 points on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Session 5 (48 Wks) - 4 weeks post-injection compared to baselinePopulation: Safety Population/Intent to Treat
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison of Wk 48 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Outcome measures
| Measure |
MYOBLOC Open Label Treatment
n=396 Participants
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Treatment Assessment Scale (TAS), Approx Wk 48 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
|
1.5 points on a scale
Standard Deviation 0.1 • Interval -3.0 to 3.0
|
SECONDARY outcome
Timeframe: Session 6 (60 Wks) - 4 weeks post-injection compared to baselinePopulation: Safety Population/Intent to Treat
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). comparison Wk 60 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Outcome measures
| Measure |
MYOBLOC Open Label Treatment
n=377 Participants
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Treatment Assessment Scale (TAS), Approx Wk 60 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
|
1.4 points on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Session 7 (72 Wks) - 4 weeks post-injection compared to baselinePopulation: Safety Population/Intent to Treat
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 72 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Outcome measures
| Measure |
MYOBLOC Open Label Treatment
n=353 Participants
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Treatment Assessment Scale (TAS), Approx Wk 72 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
|
1.5 points on a scale
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Session 8 (84 Wks) - 4 weeks post-injection compared to baselinePopulation: Safety Population/Intent to Treat
7 point scale (-3=significantly worse, 0=no change, +3=significantly better). Comparison Wk 84 + 4, compared to baseline. Rating of Cervical Dystonia Symptoms
Outcome measures
| Measure |
MYOBLOC Open Label Treatment
n=329 Participants
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Treatment Assessment Scale (TAS), Approx Wk 84 + 4 Wks Post-injection Compared to Baseline. Rating of Cervical Dystonia Symptoms
|
1.4 points on a scale
Standard Deviation 0.1
|
Adverse Events
MYOBLOC Open Label Treatment
Serious events: 133 serious events
Other events: 494 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MYOBLOC Open Label Treatment
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Cardiac disorders
Acute Coronary Syndrome
|
1.6%
8/502 • Number of events 8
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.20%
1/502 • Number of events 1
|
|
Cardiac disorders
Angina
|
0.20%
1/502 • Number of events 1
|
|
Cardiac disorders
Atrial Fibrillation
|
0.60%
3/502 • Number of events 3
|
|
Cardiac disorders
AV Block 2nd Degree
|
0.20%
1/502 • Number of events 1
|
|
Cardiac disorders
Coronary Artery Occlusion
|
0.20%
1/502 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
0.20%
1/502 • Number of events 1
|
|
Cardiac disorders
Myocardial infarction
|
0.40%
2/502 • Number of events 2
|
|
Cardiac disorders
Palpitations
|
0.20%
1/502 • Number of events 1
|
|
Cardiac disorders
Pericardial effusion
|
0.20%
1/502 • Number of events 1
|
|
Cardiac disorders
sinus bradycardia
|
0.20%
1/502 • Number of events 1
|
|
Cardiac disorders
tachycardia
|
0.20%
1/502 • Number of events 1
|
|
Ear and labyrinth disorders
vertigo
|
0.20%
1/502 • Number of events 1
|
|
Endocrine disorders
adrenal insufficiency
|
0.20%
1/502 • Number of events 1
|
|
Eye disorders
eye haemorrhage
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
abdominal adhesions
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
abdominal pain
|
0.40%
2/502 • Number of events 2
|
|
Gastrointestinal disorders
appendicitis
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
celiac disease
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
diverticulum
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
dysphagia
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
GI hemorrhage
|
0.60%
3/502 • Number of events 3
|
|
Gastrointestinal disorders
GI Reflux disease
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
inguinal hernia
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
inguinal hernia obsstructive
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
nausea
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
pancreatitis
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
small intestine obstruction
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
upper GI hemorrhage
|
0.20%
1/502 • Number of events 1
|
|
Gastrointestinal disorders
vomiting
|
0.40%
2/502 • Number of events 2
|
|
General disorders
chest discomfort
|
0.20%
1/502 • Number of events 1
|
|
General disorders
chest pain
|
0.80%
4/502 • Number of events 4
|
|
General disorders
facial pain
|
0.20%
1/502 • Number of events 1
|
|
General disorders
non cardiac chest pain
|
0.20%
1/502 • Number of events 1
|
|
General disorders
pain
|
0.20%
1/502 • Number of events 1
|
|
Hepatobiliary disorders
bile duct stone
|
0.20%
1/502 • Number of events 1
|
|
Hepatobiliary disorders
cholecystitis
|
0.20%
1/502 • Number of events 1
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.20%
1/502 • Number of events 1
|
|
Hepatobiliary disorders
cholelithiasis
|
0.80%
4/502 • Number of events 4
|
|
Hepatobiliary disorders
hepatorenal syndrome
|
0.20%
1/502 • Number of events 1
|
|
Hepatobiliary disorders
jaundice
|
0.20%
1/502 • Number of events 1
|
|
Immune system disorders
hypersensitivity
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
abdominal abscess
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
appendicitis
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
arthritis infective
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
bartholin abscess
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
GI norwalk virus
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
GI viral
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
haemophilis infection
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
pelvic abscess
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
pneumonia
|
0.40%
2/502 • Number of events 2
|
|
Infections and infestations
post operative abscess
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
pyelonephritis
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
sinusitis
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
Upper Respiratory Infection (URI)
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
Urinary Tract Infection (UTI)
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
vaginal cellulitis
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
accidental overdose
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
brain contusion
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
clavicle fracture
|
0.20%
1/502 • Number of events 1
|
|
Infections and infestations
drug toxicitiy
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
fall
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.60%
3/502 • Number of events 3
|
|
Injury, poisoning and procedural complications
incisional hernia
|
0.40%
2/502 • Number of events 2
|
|
Injury, poisoning and procedural complications
medication error
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
multiple fractures
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
overdose
|
4.0%
20/502 • Number of events 20
|
|
Injury, poisoning and procedural complications
post procedural nausea
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
post pocedural vomiting
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
post operative ileus
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
road traffic accident
|
0.80%
4/502 • Number of events 4
|
|
Injury, poisoning and procedural complications
subdural hematoma
|
0.20%
1/502 • Number of events 1
|
|
Injury, poisoning and procedural complications
upper limb fracture
|
0.20%
1/502 • Number of events 1
|
|
Investigations
oxygen saturation decrease
|
0.20%
1/502 • Number of events 1
|
|
Metabolism and nutrition disorders
dehydration
|
0.60%
3/502 • Number of events 3
|
|
Metabolism and nutrition disorders
hyperglycemia
|
0.20%
1/502 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
0.20%
1/502 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
0.20%
1/502 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back disorder
|
0.20%
1/502 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.20%
1/502 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
intervebral disc degeneration
|
0.40%
2/502 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
intervebral disc protrusion
|
0.40%
2/502 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
muscle spasm
|
0.20%
1/502 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.20%
1/502 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
0.40%
2/502 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
0.20%
1/502 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
spinal osteoarthritis
|
0.40%
2/502 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
torticollis
|
1.4%
7/502 • Number of events 7
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basal cell carcinoma
|
0.80%
4/502 • Number of events 4
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
basosquamous carcinoma
|
0.20%
1/502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
benign ovarian tumor
|
0.20%
1/502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
bone neoplasm malignant
|
0.20%
1/502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
brain neoplasm
|
0.20%
1/502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
breast cancer
|
1.00%
5/502 • Number of events 5
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
keratocanthoma
|
0.20%
1/502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
lung neoplasm malignant
|
0.20%
1/502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
malignant neoplasm progression
|
0.20%
1/502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
prostate cancer
|
0.40%
2/502 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
skin cancer
|
0.20%
1/502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma
|
0.40%
2/502 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
squamous cell carcinoma of skin
|
0.20%
1/502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
uterine leiomyoma
|
0.20%
1/502 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
vulval cancer
|
0.20%
1/502 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular Accident (CVA)
|
0.60%
3/502 • Number of events 3
|
|
Nervous system disorders
cervical myelopathy
|
0.40%
2/502 • Number of events 2
|
|
Nervous system disorders
convulsion
|
0.20%
1/502 • Number of events 1
|
|
Nervous system disorders
Dementia
|
0.20%
1/502 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
0.40%
2/502 • Number of events 2
|
|
Nervous system disorders
dystonia
|
0.20%
1/502 • Number of events 1
|
|
Nervous system disorders
epilepsy
|
0.20%
1/502 • Number of events 1
|
|
Nervous system disorders
intracranial aneurysm
|
0.20%
1/502 • Number of events 1
|
|
Nervous system disorders
mutiple sclerosis
|
0.40%
2/502 • Number of events 2
|
|
Nervous system disorders
syncope
|
0.20%
1/502 • Number of events 1
|
|
Nervous system disorders
vertebrobasilar insufficiency
|
0.20%
1/502 • Number of events 1
|
|
Pregnancy, puerperium and perinatal conditions
pregnancy
|
0.40%
2/502 • Number of events 2
|
|
Psychiatric disorders
anxiety
|
0.20%
1/502 • Number of events 1
|
|
Psychiatric disorders
confusional state
|
0.20%
1/502 • Number of events 1
|
|
Psychiatric disorders
depression
|
0.60%
3/502 • Number of events 3
|
|
Psychiatric disorders
dissociative identity disorder
|
0.20%
1/502 • Number of events 1
|
|
Psychiatric disorders
major depression
|
0.20%
1/502 • Number of events 1
|
|
Psychiatric disorders
suicidal ideation
|
0.60%
3/502 • Number of events 3
|
|
Renal and urinary disorders
bladder prolapse
|
0.20%
1/502 • Number of events 1
|
|
Renal and urinary disorders
renal failure acute
|
0.20%
1/502 • Number of events 1
|
|
Renal and urinary disorders
stress incontinence
|
0.20%
1/502 • Number of events 1
|
|
Reproductive system and breast disorders
cystocele
|
0.20%
1/502 • Number of events 1
|
|
Reproductive system and breast disorders
endometriosis
|
0.20%
1/502 • Number of events 1
|
|
Reproductive system and breast disorders
menorrhagia
|
0.20%
1/502 • Number of events 1
|
|
Reproductive system and breast disorders
ovarian cyst
|
0.20%
1/502 • Number of events 1
|
|
Reproductive system and breast disorders
ovarian cyst rupture
|
0.20%
1/502 • Number of events 1
|
|
Reproductive system and breast disorders
pelvic peritoneal adhesions
|
0.20%
1/502 • Number of events 1
|
|
Reproductive system and breast disorders
rectocele
|
0.20%
1/502 • Number of events 1
|
|
Reproductive system and breast disorders
atelectasis
|
0.40%
2/502 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
choking
|
0.20%
1/502 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
0.40%
2/502 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
0.40%
2/502 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary embolism
|
0.40%
2/502 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
pulmonary edema
|
0.20%
1/502 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
sleep apnea syndrome
|
0.20%
1/502 • Number of events 1
|
|
Vascular disorders
blood pressure fluctuation
|
0.20%
1/502 • Number of events 1
|
|
Vascular disorders
deep vein thrombosis
|
0.20%
1/502 • Number of events 1
|
|
Vascular disorders
haemotoma
|
0.20%
1/502 • Number of events 1
|
|
Vascular disorders
hypertension
|
0.60%
3/502 • Number of events 3
|
Other adverse events
| Measure |
MYOBLOC Open Label Treatment
All patients meeting enrollment criteria received open-label MYOBLOC. Patients were eligible for repeat injections approximately every 12 weeks.
|
|---|---|
|
Cardiac disorders
Palpitations
|
2.2%
11/502 • Number of events 11
|
|
Ear and labyrinth disorders
vertigo
|
3.6%
18/502 • Number of events 18
|
|
Endocrine disorders
hypothyroidism
|
2.0%
10/502 • Number of events 10
|
|
Eye disorders
cataract
|
2.0%
10/502 • Number of events 10
|
|
Eye disorders
conjunctivitis
|
2.2%
11/502 • Number of events 11
|
|
Eye disorders
dry eye
|
2.0%
10/502 • Number of events 10
|
|
Eye disorders
vision blurred
|
2.4%
12/502 • Number of events 12
|
|
Gastrointestinal disorders
abdominal pain
|
5.8%
29/502 • Number of events 29
|
|
Gastrointestinal disorders
abdominal pain upper
|
3.0%
15/502 • Number of events 15
|
|
Gastrointestinal disorders
constipation
|
8.6%
43/502 • Number of events 43
|
|
Gastrointestinal disorders
diarrhea
|
9.6%
48/502 • Number of events 48
|
|
Gastrointestinal disorders
dry mouth
|
69.3%
348/502 • Number of events 348
|
|
Gastrointestinal disorders
dyspepsia
|
9.6%
48/502 • Number of events 48
|
|
Gastrointestinal disorders
dysphagia
|
40.4%
203/502 • Number of events 203
|
|
Gastrointestinal disorders
GERD
|
8.4%
42/502 • Number of events 42
|
|
Gastrointestinal disorders
nausea
|
14.3%
72/502 • Number of events 72
|
|
Gastrointestinal disorders
toothache
|
2.0%
10/502 • Number of events 10
|
|
Gastrointestinal disorders
vomiting
|
6.0%
30/502 • Number of events 30
|
|
General disorders
asthenia
|
2.4%
12/502 • Number of events 12
|
|
General disorders
chest pain
|
5.6%
28/502 • Number of events 28
|
|
General disorders
fatigue
|
10.2%
51/502 • Number of events 51
|
|
General disorders
influenza like illness
|
5.0%
25/502 • Number of events 25
|
|
General disorders
injection site pain
|
22.7%
114/502 • Number of events 114
|
|
General disorders
injection site reaction
|
3.0%
15/502 • Number of events 15
|
|
General disorders
edema peripheral
|
5.2%
26/502 • Number of events 26
|
|
General disorders
pyrexia
|
2.4%
12/502 • Number of events 12
|
|
Infections and infestations
bronchitis
|
10.0%
50/502 • Number of events 50
|
|
Infections and infestations
cystitis
|
3.6%
18/502 • Number of events 18
|
|
Infections and infestations
ear infection
|
2.0%
10/502 • Number of events 10
|
|
Infections and infestations
fungal infection
|
2.0%
10/502 • Number of events 10
|
|
Infections and infestations
GI viral
|
4.8%
24/502 • Number of events 24
|
|
Infections and infestations
herpes zoster
|
2.0%
10/502 • Number of events 10
|
|
Infections and infestations
influenza
|
16.7%
84/502 • Number of events 84
|
|
Infections and infestations
nasopharyngitis
|
21.9%
110/502 • Number of events 110
|
|
Infections and infestations
otitis media
|
3.6%
18/502 • Number of events 18
|
|
Infections and infestations
pneumonia
|
2.0%
10/502 • Number of events 10
|
|
Infections and infestations
sinusitis
|
13.5%
68/502 • Number of events 68
|
|
Infections and infestations
tooth abscess
|
2.8%
14/502 • Number of events 14
|
|
Infections and infestations
Upper Respiratory Infection
|
13.9%
70/502 • Number of events 70
|
|
Injury, poisoning and procedural complications
joint sprain
|
3.0%
15/502 • Number of events 15
|
|
Injury, poisoning and procedural complications
muscle sprain
|
2.0%
10/502 • Number of events 10
|
|
Injury, poisoning and procedural complications
overdose
|
4.0%
20/502 • Number of events 20
|
|
Injury, poisoning and procedural complications
procedural pain
|
5.0%
25/502 • Number of events 25
|
|
Injury, poisoning and procedural complications
road traffic accident
|
3.2%
16/502 • Number of events 16
|
|
Investigations
blood cholesterol increased
|
2.2%
11/502 • Number of events 11
|
|
Metabolism and nutrition disorders
hypercholesterolemia
|
4.4%
22/502 • Number of events 22
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
12.2%
61/502 • Number of events 61
|
|
Musculoskeletal and connective tissue disorders
arthritis
|
3.6%
18/502 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
back pain
|
15.3%
77/502 • Number of events 77
|
|
Musculoskeletal and connective tissue disorders
intervertebral disc degeneration
|
2.4%
12/502 • Number of events 12
|
|
Musculoskeletal and connective tissue disorders
interverterbral disc protrusion
|
2.2%
11/502 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
muscle spasm
|
15.3%
77/502 • Number of events 77
|
|
Musculoskeletal and connective tissue disorders
muscle tightness
|
2.6%
13/502 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
8.2%
41/502 • Number of events 41
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal weakness
|
4.0%
20/502 • Number of events 20
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
5.0%
25/502 • Number of events 25
|
|
Musculoskeletal and connective tissue disorders
neck pain
|
6.4%
32/502 • Number of events 32
|
|
Musculoskeletal and connective tissue disorders
osteoarthritis
|
3.6%
18/502 • Number of events 18
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
11.2%
56/502 • Number of events 56
|
|
Musculoskeletal and connective tissue disorders
rotator cuff syndrome
|
3.0%
15/502 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
shoulder pain
|
5.8%
29/502 • Number of events 29
|
|
Musculoskeletal and connective tissue disorders
tendonitis
|
3.0%
15/502 • Number of events 15
|
|
Musculoskeletal and connective tissue disorders
torticollis
|
33.9%
170/502 • Number of events 170
|
|
Nervous system disorders
balance disorder
|
2.6%
13/502 • Number of events 13
|
|
Nervous system disorders
carpal tunnel syndrome
|
2.2%
11/502 • Number of events 11
|
|
Nervous system disorders
dizziness
|
13.5%
68/502 • Number of events 68
|
|
Nervous system disorders
head titubation
|
5.8%
29/502 • Number of events 29
|
|
Nervous system disorders
headache
|
23.3%
117/502 • Number of events 117
|
|
Nervous system disorders
hypoaesthesia
|
9.2%
46/502 • Number of events 46
|
|
Nervous system disorders
Migraine
|
4.4%
22/502 • Number of events 22
|
|
Nervous system disorders
paraesthesia
|
6.2%
31/502 • Number of events 31
|
|
Nervous system disorders
Somnolence
|
3.8%
19/502 • Number of events 19
|
|
Nervous system disorders
syncope
|
2.4%
12/502 • Number of events 12
|
|
Nervous system disorders
tremor
|
6.6%
33/502 • Number of events 33
|
|
Psychiatric disorders
anxiety
|
7.2%
36/502 • Number of events 36
|
|
Psychiatric disorders
depression
|
13.3%
67/502 • Number of events 67
|
|
Psychiatric disorders
insomnia
|
9.2%
46/502 • Number of events 46
|
|
Psychiatric disorders
stress
|
2.4%
12/502 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
choking
|
2.8%
14/502 • Number of events 14
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
10.2%
51/502 • Number of events 51
|
|
Respiratory, thoracic and mediastinal disorders
dry throat
|
3.0%
15/502 • Number of events 15
|
|
Respiratory, thoracic and mediastinal disorders
dysphonia
|
2.0%
10/502 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
3.8%
19/502 • Number of events 19
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
3.4%
17/502 • Number of events 17
|
|
Respiratory, thoracic and mediastinal disorders
pharangolaryngeal pain
|
7.2%
36/502 • Number of events 36
|
|
Skin and subcutaneous tissue disorders
pruritis
|
2.0%
10/502 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
rash
|
6.2%
31/502 • Number of events 31
|
|
Vascular disorders
hypertension
|
8.6%
43/502 • Number of events 43
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee No individual PI can disclose results until after a group manuscript is published.
- Publication restrictions are in place
Restriction type: OTHER