Trial Outcomes & Findings for Clinical Trial to Assess the Efficacy and Safety of 'Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea (NCT NCT00807027)
NCT ID: NCT00807027
Last Updated: 2025-10-10
Results Overview
Progression-free survival was assessed locally by investigators on the basis of enhanced MRI was performed approximately 4 weeks after chemoradiotherapy, then at 10, 22, 34 and 46 weeks after randomization, and every 3\~12 months thereafter during the follow-up phase.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
180 participants
Primary outcome timeframe
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months.
Results posted on
2025-10-10
Participant Flow
Participant milestones
| Measure |
Control Group
The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks.
|
CIK Immunotherapy Group
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times).
Activated T lymphocyte(Immuncell-LC): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention
Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109\~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
91
|
|
Overall Study
COMPLETED
|
73
|
74
|
|
Overall Study
NOT COMPLETED
|
16
|
17
|
Reasons for withdrawal
| Measure |
Control Group
The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks.
|
CIK Immunotherapy Group
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times).
Activated T lymphocyte(Immuncell-LC): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention
Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109\~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
13
|
14
|
|
Overall Study
Protocol Violation
|
1
|
1
|
|
Overall Study
Adverse Event
|
2
|
2
|
Baseline Characteristics
Clinical Trial to Assess the Efficacy and Safety of 'Immuncell-LC' With Temozolomide in Newly Diagnosed Glioblastoma of Korea
Baseline characteristics by cohort
| Measure |
Control Group
n=89 Participants
The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks.
|
CIK Immunotherapy Group
n=91 Participants
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times).
Activated T lymphocyte(Immuncell-LC): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention
Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109\~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.0 years
n=99 Participants
|
55.0 years
n=107 Participants
|
54.5 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
78 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=99 Participants
|
51 Participants
n=107 Participants
|
102 Participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
89 participants
n=99 Participants
|
91 participants
n=107 Participants
|
180 participants
n=206 Participants
|
|
Karnofsky performance scale
|
90 units on a scale
n=99 Participants
|
90.0 units on a scale
n=107 Participants
|
90.0 units on a scale
n=206 Participants
|
|
Global health status/Quality of life
|
50 units on a scale
n=99 Participants
|
58 units on a scale
n=107 Participants
|
54 units on a scale
n=206 Participants
|
|
Tumor size
|
1.4 centimeter
n=99 Participants
|
4.2 centimeter
n=107 Participants
|
2.8 centimeter
n=206 Participants
|
PRIMARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months.Progression-free survival was assessed locally by investigators on the basis of enhanced MRI was performed approximately 4 weeks after chemoradiotherapy, then at 10, 22, 34 and 46 weeks after randomization, and every 3\~12 months thereafter during the follow-up phase.
Outcome measures
| Measure |
Control Group
n=89 Participants
The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks.
|
CIK Immunotherapy Group
n=91 Participants
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times).
Activated T lymphocyte(Immuncell-LC): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention
Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109\~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)
|
|---|---|---|
|
Progression-free Survival(PFS)
|
5.4 months
Interval 3.3 to 7.9
|
8.1 months
Interval 5.8 to 8.5
|
SECONDARY outcome
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months.Outcome measures
| Measure |
Control Group
n=89 Participants
The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks.
|
CIK Immunotherapy Group
n=91 Participants
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times).
Activated T lymphocyte(Immuncell-LC): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention
Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109\~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)
|
|---|---|---|
|
Overall Survival(OS)
|
16.88 months
Interval 13.91 to 21.94
|
22.47 months
Interval 17.2 to 23.85
|
Adverse Events
Control Group
Serious events: 31 serious events
Other events: 83 other events
Deaths: 52 deaths
Test Group
Serious events: 35 serious events
Other events: 84 other events
Deaths: 51 deaths
Serious adverse events
| Measure |
Control Group
n=89 participants at risk
The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks.
|
Test Group
n=91 participants at risk
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times).
Activated T lymphocyte(Immuncell-LC): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention
Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109\~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)
|
|---|---|---|
|
Nervous system disorders
Convulsion
|
3.4%
3/89 • Number of events 3
|
6.6%
6/91 • Number of events 9
|
|
Nervous system disorders
Headache
|
5.6%
5/89 • Number of events 5
|
4.4%
4/91 • Number of events 5
|
|
Nervous system disorders
Brain edema
|
2.2%
2/89 • Number of events 2
|
4.4%
4/91 • Number of events 4
|
|
Nervous system disorders
Hemiparesis
|
4.5%
4/89 • Number of events 4
|
2.2%
2/91 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hydrocephalus
|
2.2%
2/89 • Number of events 2
|
3.3%
3/91 • Number of events 3
|
|
Nervous system disorders
Mental impairment
|
3.4%
3/89 • Number of events 3
|
0.00%
0/91
|
|
Nervous system disorders
Intracranial pressure increased
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Neuropathy peripheral
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
paraparesis
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Nervous system disorders
Partial seizure
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
cerebral cyst
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
cerebral infarction
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
cerebrovascular accident
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
dizziness
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
dysarthria
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
monoparesis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
myoclonus
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
somnolence
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
speech disorder
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
pneumonia
|
4.5%
4/89 • Number of events 4
|
3.3%
3/91 • Number of events 3
|
|
Infections and infestations
sepsis
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Infections and infestations
septic shock
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
appendicitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
bacteriaemia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
enterits infectious
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
lung abscess
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
meningitis aseptic
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
nasopharyngitis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
pulmonary tuberculosis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
upper respiratory tract infection
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
General disorders
pyrexia
|
2.2%
2/89 • Number of events 2
|
2.2%
2/91 • Number of events 2
|
|
General disorders
asthenia
|
1.1%
1/89 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
General disorders
chills
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
General disorders
general physical health deterioration
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
General disorders
multi-organ failure
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Injury, poisoning and procedural complications
concussion
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
femur fracture
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
hip fracture
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
rib fracure
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
subdural hemorrhage
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Blood and lymphatic system disorders
leukopenia
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Blood and lymphatic system disorders
disseminated intravascular coagulation
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Blood and lymphatic system disorders
neutropenia
|
1.1%
1/89
|
0.00%
0/91
|
|
Gastrointestinal disorders
vomiting
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
abdominal pain
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
diverticulum intestinal
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
large intestine perforation
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
nausea
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Metabolism and nutrition disorders
decreased appetite
|
0.00%
0/89
|
3.3%
3/91 • Number of events 3
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
bronchitis chronic
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia aspiration
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
pneumothroax
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Investigations
alanine aminotransferase increased
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Investigations
neutrophil count decreased
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Investigations
platelet count decreased
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Investigations
white blood cell count decreased
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Hepatobiliary disorders
hepatic steatosis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Hepatobiliary disorders
hepatitis acute
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Renal and urinary disorders
neurogenic bladder
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Renal and urinary disorders
renal failure acute
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
pruritus
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
swelling face
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
back pain
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Psychiatric disorders
depression
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
Other adverse events
| Measure |
Control Group
n=89 participants at risk
The study subjects randomly assigned to the control group is given Temozolomide chemotherapy and radiation therapy for 6 weeks according to the clinical test plans, and then administers Temozolomide only for 6 weeks.
|
Test Group
n=91 participants at risk
The study subjects assigned to the test group blood is drawn before minimum 2 weeks in order to manufacture the test drug. Test group is compared its progression free survival rate after surgery by administering Temozolomide chemotherapy and radiation therapy same as control group with Immuncell-LC (14 times).
Activated T lymphocyte(Immuncell-LC): Efficacy/Effects: Removal of minimal residual cancer after removal of brain tumors and relapse prevention
Method of administration and quantity: Test Drug: Per 60kg of average adult body weight, administer 100mg that contains 109\~2x1010 lymphocytes for one hour intravenously. (Duration of administration can be controlled based on patient conditions)
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
58.4%
52/89 • Number of events 90
|
50.5%
46/91 • Number of events 92
|
|
Gastrointestinal disorders
Constipation
|
34.8%
31/89 • Number of events 40
|
35.2%
32/91 • Number of events 40
|
|
Gastrointestinal disorders
Vomiting
|
31.5%
28/89 • Number of events 46
|
37.4%
34/91 • Number of events 65
|
|
Gastrointestinal disorders
Dyspepsia
|
22.5%
20/89 • Number of events 28
|
17.6%
16/91 • Number of events 24
|
|
Gastrointestinal disorders
Diarrhoea
|
9.0%
8/89 • Number of events 9
|
18.7%
17/91 • Number of events 18
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
3.4%
3/89 • Number of events 5
|
9.9%
9/91 • Number of events 10
|
|
Gastrointestinal disorders
Abdominal pain
|
5.6%
5/89 • Number of events 6
|
4.4%
4/91 • Number of events 8
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
2.2%
2/89 • Number of events 2
|
4.4%
4/91 • Number of events 4
|
|
Gastrointestinal disorders
Haemorrhoids
|
3.4%
3/89 • Number of events 3
|
3.3%
3/91 • Number of events 3
|
|
Gastrointestinal disorders
Stomatitis
|
1.1%
1/89 • Number of events 1
|
5.5%
5/91 • Number of events 6
|
|
Gastrointestinal disorders
Dysphagia
|
2.2%
2/89 • Number of events 3
|
3.3%
3/91 • Number of events 3
|
|
Gastrointestinal disorders
Dry mouth
|
2.2%
2/89 • Number of events 2
|
2.2%
2/91 • Number of events 2
|
|
Gastrointestinal disorders
Toothache
|
1.1%
1/89 • Number of events 1
|
3.3%
3/91 • Number of events 3
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.1%
1/89 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Gastrointestinal disorders
Abdominal Pain lower
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Faecal Incontinence
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Hematochezia
|
2.2%
2/89 • Number of events 2
|
0.00%
0/91
|
|
Gastrointestinal disorders
Mouth Ulceration
|
2.2%
2/89 • Number of events 2
|
0.00%
0/91
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Anal hemorrhage
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Diverticulum itestinal
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Gastroduodenitis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Large intestine perforation
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
Mouth hemorrhage
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Oesophagitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
Oral discomfort
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Gastrointestinal disorders
Oral mucosal blistering
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Perianal erythema
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
57.3%
51/89 • Number of events 51
|
56.0%
51/91 • Number of events 51
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
18.0%
16/89 • Number of events 20
|
14.3%
13/91 • Number of events 20
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.0%
8/89 • Number of events 10
|
9.9%
9/91 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.0%
8/89 • Number of events 8
|
5.5%
5/91 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.6%
5/89 • Number of events 5
|
4.4%
4/91 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
3.4%
3/89 • Number of events 3
|
6.6%
6/91 • Number of events 10
|
|
Skin and subcutaneous tissue disorders
Swelling Face
|
5.6%
5/89 • Number of events 6
|
3.3%
3/91 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Skin Disorder
|
2.2%
2/89 • Number of events 2
|
5.5%
5/91 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.4%
3/89 • Number of events 4
|
3.3%
3/91 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.2%
2/89 • Number of events 2
|
2.2%
2/91 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
3.4%
3/89 • Number of events 3
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
2.2%
2/89 • Number of events 2
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
2.2%
2/89 • Number of events 2
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Eczema multiforme
|
1.1%
1/89 • Number of events 2
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
intertrigo
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Leukocytoclastic vasculitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
Neurodermatitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Headache
|
32.6%
29/89 • Number of events 38
|
30.8%
28/91 • Number of events 47
|
|
Nervous system disorders
Tremor
|
14.6%
13/89 • Number of events 15
|
16.5%
15/91 • Number of events 18
|
|
Nervous system disorders
Convulsion
|
13.5%
12/89 • Number of events 16
|
16.5%
15/91 • Number of events 21
|
|
Nervous system disorders
Hemiparesis
|
13.5%
12/89 • Number of events 15
|
12.1%
11/91 • Number of events 14
|
|
Nervous system disorders
Dizziness
|
14.6%
13/89 • Number of events 17
|
7.7%
7/91 • Number of events 8
|
|
Nervous system disorders
Brain oedema
|
6.7%
6/89 • Number of events 6
|
12.1%
11/91 • Number of events 11
|
|
Nervous system disorders
Mental impairment
|
9.0%
8/89 • Number of events 11
|
9.9%
9/91 • Number of events 11
|
|
Nervous system disorders
Neuropathy peripheral
|
6.7%
6/89 • Number of events 7
|
6.6%
6/91 • Number of events 7
|
|
Nervous system disorders
Memory impairment
|
3.4%
3/89 • Number of events 3
|
7.7%
7/91 • Number of events 7
|
|
Nervous system disorders
Paresthesia
|
6.7%
6/89 • Number of events 6
|
4.4%
4/91 • Number of events 4
|
|
Nervous system disorders
dysarthria
|
3.4%
3/89 • Number of events 3
|
6.6%
6/91 • Number of events 6
|
|
Nervous system disorders
Hydrocephalus
|
4.5%
4/89 • Number of events 4
|
4.4%
4/91 • Number of events 4
|
|
Nervous system disorders
Lethargy
|
1.1%
1/89 • Number of events 1
|
7.7%
7/91 • Number of events 8
|
|
Nervous system disorders
Monoparesis
|
2.2%
2/89 • Number of events 2
|
5.5%
5/91 • Number of events 5
|
|
Nervous system disorders
Somnolence
|
4.5%
4/89 • Number of events 4
|
3.3%
3/91 • Number of events 3
|
|
Nervous system disorders
Speech disorder
|
4.5%
4/89 • Number of events 4
|
3.3%
3/91 • Number of events 4
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.2%
2/89 • Number of events 2
|
4.4%
4/91 • Number of events 6
|
|
Nervous system disorders
Hypoaesthesia
|
3.4%
3/89 • Number of events 3
|
2.2%
2/91 • Number of events 2
|
|
Nervous system disorders
VIIth nerve paralysis
|
1.1%
1/89 • Number of events 1
|
4.4%
4/91 • Number of events 4
|
|
Nervous system disorders
Cognitive disorder
|
3.4%
3/89 • Number of events 3
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/89
|
4.4%
4/91 • Number of events 4
|
|
Nervous system disorders
Partial Seizures
|
1.1%
1/89 • Number of events 2
|
3.3%
3/91 • Number of events 3
|
|
Nervous system disorders
Aphasia
|
0.00%
0/89
|
3.3%
3/91 • Number of events 3
|
|
Nervous system disorders
Facial paresis
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Nervous system disorders
Intracranial pressure increased
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Parosmia
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Amnesia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Cereral cyst
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Cerebrospinal fluid leakage
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Complex regional pain syndrome
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Head discomfort
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
Head titubation
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Intraventricular haemorrhage
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Monoplegia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Myoclonus
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
Neurologic neglect syndrome
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
Quadriplegia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Sensory disturbance
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Nervous system disorders
Stupor
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Vascular dementia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Nervous system disorders
Visual field defect
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Metabolism and nutrition disorders
Decreased appetite
|
56.2%
50/89 • Number of events 74
|
59.3%
54/91 • Number of events 71
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.5%
4/89 • Number of events 4
|
6.6%
6/91 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
2.2%
2/89 • Number of events 2
|
4.4%
4/91 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.1%
1/89 • Number of events 2
|
4.4%
4/91 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
1.1%
1/89 • Number of events 1
|
3.3%
3/91 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.5%
4/89 • Number of events 4
|
0.00%
0/91
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
2.2%
2/89 • Number of events 2
|
0.00%
0/91
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/89
|
2.2%
2/91 • Number of events 4
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypophagia
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Metabolism and nutrition disorders
Deydration
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes melitus
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Metabolism and nutrition disorders
Fluid imbalance
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Metabolism and nutrition disorders
Gout
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Metabolism and nutrition disorders
Hyperammonaemia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperchloraemia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
25.8%
23/89 • Number of events 28
|
27.5%
25/91 • Number of events 36
|
|
Infections and infestations
Upper respiratory tract infection
|
5.6%
5/89 • Number of events 6
|
7.7%
7/91 • Number of events 7
|
|
Infections and infestations
Pneumonia
|
5.6%
5/89 • Number of events 5
|
5.5%
5/91 • Number of events 5
|
|
Infections and infestations
Herpes zoster
|
2.2%
2/89 • Number of events 2
|
6.6%
6/91 • Number of events 6
|
|
Infections and infestations
Pharyngitis
|
1.1%
1/89 • Number of events 1
|
4.4%
4/91 • Number of events 4
|
|
Infections and infestations
Oral candidasis
|
4.5%
4/89 • Number of events 4
|
0.00%
0/91
|
|
Infections and infestations
Urinary tract infection
|
1.1%
1/89 • Number of events 1
|
3.3%
3/91 • Number of events 3
|
|
Infections and infestations
Infection
|
1.1%
1/89 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Infections and infestations
Otitis media
|
1.1%
1/89 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Infections and infestations
sepsis
|
0.00%
0/89
|
3.3%
3/91 • Number of events 3
|
|
Infections and infestations
Bacteriuria
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Cystitis
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Infections and infestations
Ear infection
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Herpes simplex
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Septic shock
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Tinea pedis
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Tuberculosis
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Appendicitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Bateraemia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Enteritis infectious
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Folliculitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Gingivitis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Helicobacter Gastritis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Lung abscess
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Mastoiditis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Meningitis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Meningitis asceptic
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Oral herpes
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Orchitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Otitis externa
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Paronychia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
PEritonitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Pulmonary tuberculosis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Pyelonephritis acute
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Rhinitis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Sinsitis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Stitch abscess
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Infections and infestations
Tonsllitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
General disorders
Pyrexia
|
15.7%
14/89 • Number of events 20
|
29.7%
27/91 • Number of events 47
|
|
General disorders
Asthenia
|
18.0%
16/89 • Number of events 16
|
15.4%
14/91 • Number of events 17
|
|
General disorders
Fatigue
|
13.5%
12/89 • Number of events 13
|
16.5%
15/91 • Number of events 17
|
|
General disorders
Face oedema
|
9.0%
8/89 • Number of events 8
|
7.7%
7/91 • Number of events 8
|
|
General disorders
Pain
|
7.9%
7/89 • Number of events 7
|
8.8%
8/91 • Number of events 9
|
|
General disorders
Oedema peripheral
|
2.2%
2/89 • Number of events 3
|
11.0%
10/91 • Number of events 10
|
|
General disorders
Chills
|
3.4%
3/89 • Number of events 3
|
8.8%
8/91 • Number of events 11
|
|
General disorders
oedema
|
4.5%
4/89 • Number of events 4
|
7.7%
7/91 • Number of events 7
|
|
General disorders
Chest discomfort
|
4.5%
4/89 • Number of events 4
|
6.6%
6/91 • Number of events 7
|
|
General disorders
Gait disturbance
|
2.2%
2/89 • Number of events 2
|
3.3%
3/91 • Number of events 3
|
|
General disorders
Generalised oedema
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
General disorders
General physical health deterioration
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 2
|
|
General disorders
Chest pain
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Feeling abnormal
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
General disorders
Gait deviation
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
General disorders
Hyperthermia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
General disorders
Inflammation
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
General disorders
Local swelling
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
General disorders
Multi-organ failure
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
12.4%
11/89 • Number of events 11
|
20.9%
19/91 • Number of events 19
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.1%
9/89 • Number of events 10
|
12.1%
11/91 • Number of events 11
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
9.0%
8/89 • Number of events 8
|
6.6%
6/91 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
5/89 • Number of events 5
|
9.9%
9/91 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
2/89 • Number of events 2
|
5.5%
5/91 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
2/89 • Number of events 2
|
4.4%
4/91 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
2.2%
2/89 • Number of events 3
|
3.3%
3/91 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
2.2%
2/89 • Number of events 2
|
3.3%
3/91 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.1%
1/89 • Number of events 1
|
3.3%
3/91 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.2%
2/89 • Number of events 2
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
2.2%
2/89 • Number of events 2
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
Hypercreatinaemia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Neck mass
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
11.2%
10/89 • Number of events 11
|
19.8%
18/91 • Number of events 23
|
|
Investigations
Neutrophil count decreased
|
7.9%
7/89 • Number of events 8
|
16.5%
15/91 • Number of events 19
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
6/89 • Number of events 7
|
9.9%
9/91 • Number of events 10
|
|
Investigations
Platelet count decreased
|
3.4%
3/89 • Number of events 3
|
9.9%
9/91 • Number of events 12
|
|
Investigations
White blood cell count decreased
|
2.2%
2/89 • Number of events 3
|
8.8%
8/91 • Number of events 18
|
|
Investigations
Haemoglobin decreased
|
2.2%
2/89 • Number of events 2
|
5.5%
5/91 • Number of events 6
|
|
Investigations
Hepatic enzyme increased
|
4.5%
4/89 • Number of events 4
|
2.2%
2/91 • Number of events 2
|
|
Investigations
Blood sodium decreased
|
2.2%
2/89 • Number of events 2
|
3.3%
3/91 • Number of events 3
|
|
Investigations
Weight decreased
|
1.1%
1/89 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Investigations
Ammonia increased
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Investigations
Blood potassium decreased
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Investigations
Skin test positive
|
0.00%
0/89
|
2.2%
2/91 • Number of events 15
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Investigations
Clostridium test positive
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Investigations
Electocardiogram T wave abnormal
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.9%
7/89 • Number of events 8
|
11.0%
10/91 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.6%
5/89 • Number of events 5
|
9.9%
9/91 • Number of events 11
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.5%
4/89 • Number of events 5
|
11.0%
10/91 • Number of events 10
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.1%
1/89 • Number of events 1
|
5.5%
5/91 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
rhinorrhoea
|
3.4%
3/89 • Number of events 3
|
2.2%
2/91 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
2.2%
2/89 • Number of events 5
|
2.2%
2/91 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Emphysema
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Increased bronchial secretion
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Respiratory, thoracic and mediastinal disorders
Slep apnoea syndrome
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Dry eye
|
3.4%
3/89 • Number of events 3
|
6.6%
6/91 • Number of events 6
|
|
Eye disorders
Eye pain
|
6.7%
6/89 • Number of events 6
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Visual impairment
|
3.4%
3/89 • Number of events 3
|
2.2%
2/91 • Number of events 2
|
|
Eye disorders
Diplopia
|
3.4%
3/89 • Number of events 3
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Eyelid oedema
|
4.5%
4/89 • Number of events 4
|
0.00%
0/91
|
|
Eye disorders
Conjunctivitis
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Foreign body sensation in eyes
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Eye disorders
Vision blurred
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Blepharitis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Cataract
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Corneal erosion
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Eye disorders
Eye inflammation
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Eye oedema
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Eye swelling
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Eye disorders
Glare
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Ocular discomfort
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Eye disorders
Retinal degeneration
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Eye disorders
Visual activity reduced
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
13.5%
12/89 • Number of events 13
|
14.3%
13/91 • Number of events 16
|
|
Blood and lymphatic system disorders
Leukopenia
|
7.9%
7/89 • Number of events 8
|
17.6%
16/91 • Number of events 26
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.4%
3/89 • Number of events 4
|
4.4%
4/91 • Number of events 8
|
|
Blood and lymphatic system disorders
Lymphopenia
|
2.2%
2/89 • Number of events 3
|
4.4%
4/91 • Number of events 6
|
|
Blood and lymphatic system disorders
Anaemia
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Blood and lymphatic system disorders
Splenomegaly
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Psychiatric disorders
Insomnia
|
10.1%
9/89 • Number of events 9
|
8.8%
8/91 • Number of events 10
|
|
Psychiatric disorders
Depression
|
6.7%
6/89 • Number of events 7
|
5.5%
5/91 • Number of events 5
|
|
Psychiatric disorders
Mood altered
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Psychiatric disorders
Depressed mood
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Psychiatric disorders
Psychotic disorder
|
2.2%
2/89 • Number of events 2
|
0.00%
0/91
|
|
Psychiatric disorders
Anxiety
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Psychiatric disorders
Anxiety disorder
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Psychiatric disorders
Mood disorder due to a general medical condition
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Psychiatric disorders
Personality change
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Psychiatric disorders
Personality disorder
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/89
|
1.1%
1/91 • Number of events 2
|
|
Renal and urinary disorders
Urinary incontinence
|
5.6%
5/89 • Number of events 5
|
3.3%
3/91 • Number of events 3
|
|
Renal and urinary disorders
Dysuria
|
1.1%
1/89 • Number of events 1
|
6.6%
6/91 • Number of events 6
|
|
Renal and urinary disorders
Haematuria
|
1.1%
1/89 • Number of events 1
|
5.5%
5/91 • Number of events 5
|
|
Renal and urinary disorders
Micturition disorder
|
1.1%
1/89 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Renal and urinary disorders
Nurogenic bladder
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
Pollakiuria
|
1.1%
1/89 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Renal and urinary disorders
Bladder dilatation
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
Calculus bladder
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
Enurresis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
Micturition urgency
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Renal and urinary disorders
Rnal tubular necrosis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
Excoriation
|
2.2%
2/89 • Number of events 2
|
4.4%
4/91 • Number of events 5
|
|
Injury, poisoning and procedural complications
Ear abrasion
|
1.1%
1/89 • Number of events 1
|
3.3%
3/91 • Number of events 3
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/89
|
3.3%
3/91 • Number of events 3
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
Contusion
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 3
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
Joint disclocation
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
Post procedural oedema
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin injury
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Injury, poisoning and procedural complications
Subdural haemorrhage
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Vascular disorders
Hypotension
|
1.1%
1/89 • Number of events 1
|
5.5%
5/91 • Number of events 6
|
|
Vascular disorders
Flushing
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Vascular disorders
Hypertension
|
2.2%
2/89 • Number of events 2
|
1.1%
1/91 • Number of events 1
|
|
Vascular disorders
shock
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Ear and labyrinth disorders
Tinnitus
|
2.2%
2/89 • Number of events 3
|
3.3%
3/91 • Number of events 3
|
|
Ear and labyrinth disorders
Ear pain
|
1.1%
1/89 • Number of events 1
|
2.2%
2/91 • Number of events 2
|
|
Ear and labyrinth disorders
otorrhoea
|
1.1%
1/89 • Number of events 1
|
2.2%
2/91 • Number of events 4
|
|
Ear and labyrinth disorders
Deafness
|
1.1%
1/89 • Number of events 1
|
1.1%
1/91 • Number of events 1
|
|
Ear and labyrinth disorders
Auricular swelling
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/89
|
2.2%
2/91 • Number of events 2
|
|
Reproductive system and breast disorders
Calculus prostatic
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Reproductive system and breast disorders
Galactorrhoea
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Reproductive system and breast disorders
Genital discharge
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Reproductive system and breast disorders
Menopausal symptoms
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Reproductive system and breast disorders
Perineal pain
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Reproductive system and breast disorders
Vulvovaginal swelling
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Immune system disorders
Hypersensitivity
|
4.5%
4/89 • Number of events 4
|
1.1%
1/91 • Number of events 4
|
|
Hepatobiliary disorders
Hepatic steatosis
|
2.2%
2/89 • Number of events 2
|
0.00%
0/91
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Hepatobiliary disorders
Hepatitis
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Hepatobiliary disorders
Hepatitis acute
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Cardiac disorders
Ventricular dysfunction
|
0.00%
0/89
|
1.1%
1/91 • Number of events 1
|
|
Endocrine disorders
Cushing's syndrome
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Endocrine disorders
Cushingoid
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Endocrine disorders
Thyroid mass
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
1.1%
1/89 • Number of events 1
|
0.00%
0/91
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place