Trial Outcomes & Findings for Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma (NCT NCT00179647)
NCT ID: NCT00179647
Last Updated: 2010-03-16
Results Overview
Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1913 participants
Primary outcome timeframe
Median time-on-study=18.3 weeks
Results posted on
2010-03-16
Participant Flow
Participant milestones
| Measure |
Lenalidomide
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
|
|---|---|
|
Overall Study
STARTED
|
1913
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
1913
|
Reasons for withdrawal
| Measure |
Lenalidomide
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
|
|---|---|
|
Overall Study
Adverse Event
|
294
|
|
Overall Study
Lack of Efficacy
|
478
|
|
Overall Study
Withdrawal by Subject
|
83
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Death
|
94
|
|
Overall Study
Other
|
960
|
Baseline Characteristics
Expanded Access Program:Lenalidomide With or Without Dexamethasone In Previously Treated Subjects With Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=1913 Participants
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1090 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
823 Participants
n=5 Participants
|
|
Age Continuous
|
63.4 years
STANDARD_DEVIATION 10.31 • n=5 Participants
|
|
Sex: Female, Male
Female
|
762 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1151 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
1183 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
730 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Median time-on-study=18.3 weeksData from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Median time-on-study=18.3 weeksPopulation: Subjects who received study drug
Data from all subjects who received any study drug were included in the analysis. Adverse events were classified using the Medical Dictionary for Regulatory Activities (MedDRA) classification system. A subject having the same event more than once was counted only once. Adverse events were summarized by worst NCI (National Cancer Institute) CTCAE (Common Terminology Criteria for Adverse Events) VERSION 3.0 grade. Incidence was defined as the number of subjects who experienced an adverse event within their period of participation in this study.
Outcome measures
| Measure |
Lenalidomide
n=1913 Participants
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
|
|---|---|
|
Overall Incidence of Adverse Events
|
1877 Participants
|
Adverse Events
Lenalidomide
Serious events: 878 serious events
Other events: 1877 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide
n=1913 participants at risk
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
0.26%
5/1913 • Number of events 6 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
BRADYCARDIA
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
BRAIN OEDEMA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
BREAST CANCER
|
0.21%
4/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL OBSTRUCTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
BRONCHIECTASIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
BRONCHIOLITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS
|
0.52%
10/1913 • Number of events 10 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHITIS CHRONIC
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
BRONCHOPNEUMONIA
|
0.21%
4/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHOSPASM
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
CANDIDA SEPSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
CANDIDAL INFECTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
CARDIAC AMYLOIDOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
CARDIAC ARREST
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
1.3%
24/1913 • Number of events 27 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
0.21%
4/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
CARDIOMYOPATHY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
CARDIOPULMONARY FAILURE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
CATHETER SEPSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
CATHETER SITE CELLULITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
CATHETER SITE HAEMORRHAGE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
CELLULITIS
|
0.78%
15/1913 • Number of events 15 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
CENTRAL LINE INFECTION
|
0.16%
3/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
CEREBRAL HAEMATOMA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
CEREBRAL HAEMORRHAGE
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
CEREBRAL ISCHAEMIA
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
CEREBROVASCULAR ACCIDENT
|
0.52%
10/1913 • Number of events 10 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
CERVICAL VERTEBRAL FRACTURE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
CHEST PAIN
|
0.47%
9/1913 • Number of events 9 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
CHEST WALL PAIN
|
0.37%
7/1913 • Number of events 8 • Median time-on-study=18.3 weeks
|
|
Hepatobiliary disorders
CHOLANGITIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Hepatobiliary disorders
CHOLELITHIASIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
CHONDROCALCINOSIS PYROPHOSPHATE
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE AIRWAY DISEASE EXACERBATED
|
0.42%
8/1913 • Number of events 9 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
CHRONIC OBSTRUCTIVE AIRWAYS DISEASE
|
0.16%
3/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
CIRCULATORY COLLAPSE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
CLOSTRIDIAL INFECTION
|
0.16%
3/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
CLOSTRIDIUM COLITIS
|
0.52%
10/1913 • Number of events 10 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
COLITIS
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
COLONIC FISTULA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
COLONIC PERFORATION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
COMA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
COMPRESSION FRACTURE
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
CONFUAIONAL STATE
|
1.5%
28/1913 • Number of events 31 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Skin and subcutaneous tissue disorders
CONTUSION
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
CONVULSIONS
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
CORONARY ARTERY DISEASE
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
CORONARY ARTERY INSUFFICIENCY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Ear and labyrinth disorders
DEAFNESS NEUROSENSORY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Ear and labyrinth disorders
DEAFNESS UNILATERAL
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
DEATH
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
2.7%
52/1913 • Number of events 52 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.1%
41/1913 • Number of events 48 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
DELERIUM
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
DEPRESSION
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Skin and subcutaneous tissue disorders
DERMATITIS BULLOUS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Skin and subcutaneous tissue disorders
DERMATITIS MEDICAMENTOSA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
DIABETES MELLITUS
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
DIABETIC HYPEROSMOLAR NON-KETOACIDOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
DIABETIC KETOACIDOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.94%
18/1913 • Number of events 18 • Median time-on-study=18.3 weeks
|
|
General disorders
DIFFICULTY IN WALKING
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Eye disorders
DIPLOPIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
DISORIENTATION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
DISSEMINATED INTRAVASCULAR COAGULATION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
DIVERTICULAR PERFORATION
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
DIVERTICULITIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
DIZZINESS
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Immune system disorders
DRUG HYPERSENSITIVITY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
DRUG WITHDRAWAL SYNDROME
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
DUODENITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
DYSLIPIDAEMIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
DYSPHAGIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNEA
|
2.2%
42/1913 • Number of events 46 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
ELECTROCARDIOGRAM QT PROLONGED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.21%
4/1913 • Number of events 7 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
EMBOLISM
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
ENCEPHALOPATHY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
ENDOCARDITIS INFECTIVE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
ENTERITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
ENTEROCOLITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.21%
4/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
EPIGLOTTITIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA MULTIFORME
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
ESCHERICHIA URINARY TRACT INFECTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
EYE INFECTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
FAECAL INCONTINENCE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
FAILURE TO THRIVE
|
0.37%
7/1913 • Number of events 7 • Median time-on-study=18.3 weeks
|
|
General disorders
FALL
|
0.37%
7/1913 • Number of events 7 • Median time-on-study=18.3 weeks
|
|
General disorders
FATIGUE
|
1.5%
29/1913 • Number of events 29 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
3.3%
64/1913 • Number of events 75 • Median time-on-study=18.3 weeks
|
|
General disorders
FEELING COLD
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
FEMUR FRACTURE
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
FRACTURE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
FUNGAL INFECTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
FUNGAL SEPSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
GAIT ABNORMAL
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Investigations
GAMMA-GLUTAMYLTRANSFERASE INCREASED
|
0.05%
1/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
GANGRENE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
GASTRIC ULCER
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
GASTROENTERITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
GASTROENTERITIS BACTERIAL
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
GASTROENTERITIS VIRAL
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
GASTROINTESTINAL HAEMORRHAGE
|
1.0%
20/1913 • Number of events 20 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
GASTROINTESTINAL NECROSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
GASTROINTESTINAL PERFORATION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
GASTROINTESTINAL TRACT CANCER
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
GOUT
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Immune system disorders
GRAFT VERSUS HOST DISEASE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
GRAM-POSITIVE BACTERIAL INFECTION
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
GROIN PAIN
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
ABDOMINAL ABSCESS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
ABDOMINAL DISTENSION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
ABDOMINAL HAEMATOMA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.37%
7/1913 • Number of events 7 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
ABDOMINAL STRANGULATED HERNIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
ACUTE CORONARY SYNDROME
|
0.10%
2/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
ACUTE DIVERTICULITIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY DISTRESS SYNDROME
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
ACUTE RESPIRATORY FAILURE
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Endocrine disorders
ADRENAL INSUFFICIENCY
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
AGITATION
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
ANEMIA
|
3.6%
68/1913 • Number of events 75 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
ANGINA PECTORIS
|
0.31%
6/1913 • Number of events 7 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
ANGINA UNSTABLE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
ANOREXIA
|
0.37%
7/1913 • Number of events 8 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
ANURIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
ANXIETY
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
APPENDICITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
APPETITE DECREASED
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
ARRHYTHMIA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Congenital, familial and genetic disorders
ARTERIOVENOUS MALFORMATION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
0.63%
12/1913 • Number of events 12 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
ARTHRITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
ARTHRITIS BACTERIAL
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
ARTHRITIS INFECTIVE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
ASEPTIC NECROSIS BONE
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
ASPERGILLOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
ASPIRATION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
ASTHENIA
|
1.8%
35/1913 • Number of events 36 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
ASTHMA
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
ATAXIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
1.7%
32/1913 • Number of events 36 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.21%
4/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
AZOTAEMIA
|
0.10%
2/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B-CELL LYMPHOMA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
1.5%
29/1913 • Number of events 30 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
BACTERAEMIA
|
0.52%
10/1913 • Number of events 10 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
BACTERIAL INFECTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
BACTERIAL SEPSIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Hepatobiliary disorders
BILE DUCT STONE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
BLOOD AMYLASE INCREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Investigations
BLOOD CREATININE INCREASED
|
0.89%
17/1913 • Number of events 17 • Median time-on-study=18.3 weeks
|
|
Investigations
BLOOD GLUCOSE INCREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
BLOOD HUMAN CHORIONIC GONADOTROPIN INCREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
BLOOD UREA INCREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
BONE LESION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
HAEMATOCRIT DECREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
HAEMATOMA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Investigations
HAEMOGLOBIN DECREASED
|
0.26%
5/1913 • Number of events 6 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
HEART RATE INCREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
HEMIPARESIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Hepatobiliary disorders
HEPATITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
HERNIA
|
0.05%
1/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
HERPES ZOSTER
|
0.37%
7/1913 • Number of events 7 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
HICCUPS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Surgical and medical procedures
HIP ARTHROPLASTY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
HIP FRACTURE
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
HOT FLUSHES
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
HUMERUS FRACTURE
|
0.21%
4/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Eye disorders
HYALITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
0.52%
10/1913 • Number of events 11 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
HYPERCALCEMIA
|
0.84%
16/1913 • Number of events 16 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
0.99%
19/1913 • Number of events 19 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
HYPERKALEMIA
|
0.42%
8/1913 • Number of events 8 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
HYPERTENSION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
HYPERTENSIVE CRISIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
HYPERVISCOSITY SYNDROME
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
HYPOAESTHESIA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
HYPOCALCAEMIA
|
0.31%
6/1913 • Number of events 7 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
HYPOGLYCAEMIA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
HYPOKALEMIA
|
0.58%
11/1913 • Number of events 12 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.42%
8/1913 • Number of events 9 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
HYPOPHOSPHATAEMIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
HYPOTENSION
|
1.1%
21/1913 • Number of events 22 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
0.37%
7/1913 • Number of events 7 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
ILEUS PARALYTIC
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
ILIAC ARTERY STENOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
IMPAIRED GASTRIC EMPTYING
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Endocrine disorders
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
INFECTION
|
0.99%
19/1913 • Number of events 19 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
INFLUENZA
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
General disorders
INJECTION SITE THROMBOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
INSOMNIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
INTERNATIONAL NORMALISED RATIO INCREASED
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
INTERSTITIAL PNEUMONIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
INTESTINAL MASS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
INTESTINAL PERFORATION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
INTRA-ABDOMINAL HAEMORRHAGE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
INTRACTABLE PAIN
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Hepatobiliary disorders
JAUNDICE
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Hepatobiliary disorders
JAUNDICE CHOLESTATIC
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
JOINT EFFUSION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
JOINT SWELLING
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
LARGE INTESTINAL PERFORATION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
LARYNGITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
LETHARGY
|
0.21%
4/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LEUKAEMIA PLASMACYTIC
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.31%
6/1913 • Number of events 6 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
LISTERIOSIS
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
LIVER FUNCTION TESTS ABNORMAL
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
LOBAR PNEUMONIA
|
0.63%
12/1913 • Number of events 13 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
LOCALISED INFECTION
|
0.26%
5/1913 • Number of events 6 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
LOSS OF CONSCIOUSNESS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
0.21%
4/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
LUNG ABSCESS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
LUNG CONSOLIDATION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
LUNG INFECTION
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
LUNG INFILTRATION
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
LUNG SQUAMOUS CELL CARCINOMA STAGE UNSPECIFIED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
LYMPHOPENIA
|
0.05%
1/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MALIGNANT PLEURAL EFFUSION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
MANIA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
MEDICATION ERROR
|
0.26%
5/1913 • Number of events 6 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
MELAENA
|
0.05%
1/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
MENINGITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
MENINGITIS PNEUMOCOCCAL
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
MENTAL STATUS CHANGES
|
0.78%
15/1913 • Number of events 15 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
METABOLIC ACIDOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
METABOLIC ENCEPHALOPATHY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO BRAIN
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO SKIN
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTATIC MALIGNANT MELANOMA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
MICTURITION DISORDER
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
MIGRAINE WITH AURA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
MOOD ALTERATION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
MOUTH HAEMORRHAGE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
MUCORMYCOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MULTIPLE MYELOMA
|
2.6%
50/1913 • Number of events 50 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE CRAMP
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE TWITCHING
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
0.37%
7/1913 • Number of events 8 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
MYCOBACTERIUM AVIUM COMPLEX INFECTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
MYELITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
MYOCARDIAL INFARCTION
|
0.73%
14/1913 • Number of events 14 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
MYOCARDIAL ISCHAEMIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
MYOSITIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
NAUSEA
|
0.58%
11/1913 • Number of events 11 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
NECROTISING FASCIITIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
NEPHRITIS INTERSTITIAL
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
NEUROLOGICAL SYMPTOMS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
NEUROPATHIC PAIN
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
NEUROPATHY
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
2.4%
45/1913 • Number of events 46 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
NEUTROPENIC SEPSIS
|
0.47%
9/1913 • Number of events 9 • Median time-on-study=18.3 weeks
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
OEDEMA
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
General disorders
OEDEMA PERIPHERAL
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
OESOPHAGITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
OLIGURIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
OPPORTUNISTIC INFECTION
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
ORAL CANDIDIASIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
ORAL INFECTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
General disorders
ORGAN FAILURE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
ORTHOSTATIC HYPOTENSION
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
OSTEOMYELITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
OVERDOSE
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Investigations
OXYGEN SATURATION DECREASED
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
General disorders
PAIN
|
0.73%
14/1913 • Number of events 16 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
PAIN IN LIMB
|
0.16%
3/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
PAIN TRAUMA ACTIVATED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
PALATAL DISORDER
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
PALPITATIONS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PANCREATIC CARCINOMA METASTATIC
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
PANCREATITIS
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
1.6%
31/1913 • Number of events 31 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
PANIC ATTACK
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PARAINFLUENZAE VIRUS INFECTION
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PAROTITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
PATHOLOGICAL FRACTURE
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Reproductive system and breast disorders
PELVIC PAIN
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
PEPTIC ULCER
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
PEPTIC ULCER HAEMORRHAGE
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
PERICARDITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
PERIPHERAL ARTERY ANEURYSM
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
PERIPHERAL ISCHAEMIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
PERIPHERAL NEUROPATHY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
PERIPHERAL SENSORY NEUROPATHY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
PERIPHERAL SWELLING
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PERITONSILLAR ABSCESS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PHARYNGITIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
PLASMACYTOMA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.0%
20/1913 • Number of events 21 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PLEURISY
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PLEURITIC PAIN
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PNEUMOCOCCAL BACTERAEMIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PNEUMOCOCCAL SEPSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PNEUMOCYSTIS CARINII PNEUMONIA
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PNEUMONIA
|
8.8%
168/1913 • Number of events 189 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONIA ASPIRATION
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PNEUMONIA PNEUMOCOCCAL
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PNEUMONIA PRIMARY ATYPICAL
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PNEUMONIA RESPIRATORY SYNCYTIAL VIRAL
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PNEUMONIA STAPHYLOCOCCAL
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PNEUMONIA STREPTOCOCCAL
|
0.37%
7/1913 • Number of events 7 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PNEUMONIA VIRAL
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMONITIS
|
0.31%
6/1913 • Number of events 6 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
POLYDIPSIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
PROTHROMBIN TIME PROLONGED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PSEUDOMONAL SEPSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
PSOAS ABSCESS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
PSYCHOTIC DISORDER
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY ALVEOLAR HAEMORRHAGE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY CONGESTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.5%
29/1913 • Number of events 29 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HYPERTENSION
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
PULMONARY OEDEMA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY OEDEMA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
General disorders
PYREXIA
|
3.6%
68/1913 • Number of events 74 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
RADIATION OESOPHAGITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Skin and subcutaneous tissue disorders
RASH MACULAR
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
RECTAL ABSCESS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
RECTAL HAEMORRHAGE
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
RECTOVAGINAL FISTULA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
RENAL FAILURE
|
1.6%
31/1913 • Number of events 32 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE
|
2.1%
41/1913 • Number of events 45 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
RENAL FAILURE ACUTE ON CHRONIC
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
RENAL FAILURE CHRONIC
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
RENAL IMPAIRMENT
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
RENAL MASS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
RENAL TUBULAR NECROSIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ACIDOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DEPRESSION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY DISTRESS
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY FAILURE
|
0.68%
13/1913 • Number of events 13 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
RESPIRATORY SYNCYTIAL VIRUS INFECTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.42%
8/1913 • Number of events 8 • Median time-on-study=18.3 weeks
|
|
Eye disorders
RETINAL VEIN THROMBOSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
RETROPERITONEAL HAEMORRHAGE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
RHABDOMYOLYSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
RIB FRACTURE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
RIGHT VENTRICULAR FAILURE
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
General disorders
RIGORS
|
0.37%
7/1913 • Number of events 7 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
RUPTURED DIVERTICULUM
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
SALMONELLA BACTERAEMIA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
SEPSIS
|
2.0%
39/1913 • Number of events 39 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
SEPTIC SHOCK
|
0.89%
17/1913 • Number of events 17 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
SICK SINUS SYNDROME
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
SIMPLE PARTIAL SEIZURES
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
SINUSITIS
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
SINUSITIS ACUTE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
SKIN AND SUBCUTANEOUS TISSUE ABSCESS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Skin and subcutaneous tissue disorders
SKIN BLEEDING
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Skin and subcutaneous tissue disorders
SKIN ULCER
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
SMALL INTESTINAL OBSTRUCTION
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
SOMNOLENCE
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
SPINAL COMPRESSION FRACTURE
|
0.31%
6/1913 • Number of events 6 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
SPINAL CORD COMPRESSION
|
0.63%
12/1913 • Number of events 12 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
SPINAL EPIDURAL HAEMORRHAGE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
SPONDYLOLISTHESIS ACQUIRED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
SQUAMOUS CELL CARCINOMA OF SKIN
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
STAPHYLOCOCCAL BACTERAEMIA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
STAPHYLOCOCCAL SEPSIS
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
STATUS EPILEPTICUS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
STOMATITIS
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
STREPTOCOCCAL SEPSIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
SUBARACHNOID HAEMORRHAGE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
SUPERIOR VENA CAVAL OCCLUSION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
SYNCOPE
|
1.0%
20/1913 • Number of events 22 • Median time-on-study=18.3 weeks
|
|
General disorders
SYSTEMIC INFLAMMATORY RESPONSE SYNDROME
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
TACHYCARDIA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
THERAPEUTIC AGENT POISONING
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
THERMAL BURN
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
4.1%
79/1913 • Number of events 92 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
THROMBOPHLEBITIS
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
THROMBOPHLEBITIS SUPERFICIAL
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Vascular disorders
THROMBOSIS
|
0.21%
4/1913 • Number of events 4 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
THROMBOTIC STROKE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
TIBIA FRACTURE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
TONSILLITIS ACUTE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
TRANSAMINASES INCREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
TRANSFUSION REACTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
TRANSIENT ISCHAEMIC ATTACK
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Investigations
TROPONIN
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Investigations
TROPONIN INCREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
TUMOUR ASSOCIATED FEVER
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
General disorders
ULCER
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
UPPER GASTROINTESTINAL HAEMORRHAGE
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Injury, poisoning and procedural complications
UPPER LIMB FRACTURE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
UPPER RESPIRATORY TRACT CONGESTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
0.52%
10/1913 • Number of events 10 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
URETHRAL HAEMORRHAGE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
URINARY INCONTINENCE
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Renal and urinary disorders
URINARY RETENTION
|
0.16%
3/1913 • Number of events 3 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
URINARY TRACT INFECTION
|
1.2%
22/1913 • Number of events 22 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
URINARY TRACT INFECTION ENTEROCOCCAL
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
UROSEPSIS
|
0.26%
5/1913 • Number of events 5 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
VASOVAGAL ATTACK
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Investigations
VENOUS PRESSURE JUGULAR INCREASED
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Cardiac disorders
VENTRICULAR TACHYCARDIA
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
VIRAL INFECTION
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Eye disorders
VISUAL DISTURBANCE
|
0.05%
1/1913 • Number of events 1 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
VOMITING
|
0.84%
16/1913 • Number of events 16 • Median time-on-study=18.3 weeks
|
|
Investigations
WEIGHT DECREASED
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
WOUND INFECTION
|
0.10%
2/1913 • Number of events 2 • Median time-on-study=18.3 weeks
|
Other adverse events
| Measure |
Lenalidomide
n=1913 participants at risk
This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
|
|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
22.1%
423/1913 • Number of events 606 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
ANOREXIA
|
10.2%
195/1913 • Number of events 221 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
APPETITE DECREASED
|
5.8%
111/1913 • Number of events 118 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.4%
218/1913 • Number of events 267 • Median time-on-study=18.3 weeks
|
|
General disorders
ASTHENIA
|
14.5%
277/1913 • Number of events 338 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.4%
276/1913 • Number of events 322 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
5.2%
100/1913 • Number of events 116 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
CONSTIPATION
|
24.6%
471/1913 • Number of events 540 • Median time-on-study=18.3 weeks
|
|
Skin and subcutaneous tissue disorders
CONTUSION
|
6.4%
123/1913 • Number of events 154 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
15.7%
301/1913 • Number of events 349 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
DIARRHOEA
|
22.5%
430/1913 • Number of events 572 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
DIZZINESS
|
13.6%
261/1913 • Number of events 321 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
DYSGEUSIA
|
8.9%
171/1913 • Number of events 185 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
DYSPEPSIA
|
6.7%
129/1913 • Number of events 148 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
15.5%
296/1913 • Number of events 355 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA EXERTIONAL
|
5.1%
98/1913 • Number of events 110 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
6.0%
114/1913 • Number of events 129 • Median time-on-study=18.3 weeks
|
|
General disorders
FATIGUE
|
56.0%
1072/1913 • Number of events 1448 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
HEADACHE
|
9.0%
173/1913 • Number of events 211 • Median time-on-study=18.3 weeks
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
6.6%
127/1913 • Number of events 189 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
HYPOAESTHESIA
|
5.5%
106/1913 • Number of events 120 • Median time-on-study=18.3 weeks
|
|
Psychiatric disorders
INSOMNIA
|
20.2%
386/1913 • Number of events 424 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE CRAMP
|
25.6%
490/1913 • Number of events 713 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
MUSCLE WEAKNESS
|
7.6%
146/1913 • Number of events 183 • Median time-on-study=18.3 weeks
|
|
Respiratory, thoracic and mediastinal disorders
NASOPHARYNGITIS
|
8.4%
161/1913 • Number of events 209 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
NAUSEA
|
18.9%
362/1913 • Number of events 455 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
NEUROPATHY
|
7.8%
149/1913 • Number of events 189 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
32.3%
618/1913 • Number of events 1185 • Median time-on-study=18.3 weeks
|
|
General disorders
OEDEMA PERIPHERAL
|
14.9%
285/1913 • Number of events 371 • Median time-on-study=18.3 weeks
|
|
Musculoskeletal and connective tissue disorders
PAIN IN LIMB
|
7.1%
136/1913 • Number of events 162 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
PERIPHERAL NEUROPATHY
|
5.4%
104/1913 • Number of events 123 • Median time-on-study=18.3 weeks
|
|
General disorders
PYREXIA
|
12.2%
233/1913 • Number of events 297 • Median time-on-study=18.3 weeks
|
|
Skin and subcutaneous tissue disorders
RASH
|
14.3%
273/1913 • Number of events 368 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
STOMATITIS
|
6.4%
123/1913 • Number of events 140 • Median time-on-study=18.3 weeks
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
21.3%
408/1913 • Number of events 725 • Median time-on-study=18.3 weeks
|
|
Nervous system disorders
TREMOR
|
10.4%
198/1913 • Number of events 236 • Median time-on-study=18.3 weeks
|
|
Infections and infestations
UPPER RESPIRATORY TRACT INFECTION
|
13.1%
250/1913 • Number of events 325 • Median time-on-study=18.3 weeks
|
|
Eye disorders
VISION BLURRED
|
8.1%
154/1913 • Number of events 164 • Median time-on-study=18.3 weeks
|
|
Gastrointestinal disorders
VOMITING
|
7.4%
142/1913 • Number of events 187 • Median time-on-study=18.3 weeks
|
|
Investigations
WEIGHT DECREASED
|
6.0%
115/1913 • Number of events 126 • Median time-on-study=18.3 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The investigator shall have the right to publish and/or present the clinical data generated from the study provided that such Investigator shall furnish sponsor with a copy of the proposed publication or presentation at least 60 days in advance of submission, delete any confidential information, and delay submission for up to 90 days to permit the preparation and filing of appropriate intellectual property applications.
- Publication restrictions are in place
Restriction type: OTHER