Trial Outcomes & Findings for Natalizumab (Tysabri) Re-Initiation of Dosing (NCT NCT00297232)
NCT ID: NCT00297232
Last Updated: 2016-07-15
Results Overview
Time to 24-week confirmed EDSS progression in participants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and \< 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 24 weeks.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
1094 participants
Primary outcome timeframe
up to 480 weeks
Results posted on
2016-07-15
Participant Flow
Participants from studies 101-MS-321 (NCT00297232) and 101-MS-322 (NCT00306592) are included in this presentation of combined final data. Note: In the Participant Flow table, 'progressive multifocal leukoencephalopathy' is abbreviated to 'PML'. and John Cunningham virus is abbreviated to 'JCV'.
Participant milestones
| Measure |
Natalizumab
300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
|
|---|---|
|
Overall Study
STARTED
|
1094
|
|
Overall Study
COMPLETED
|
489
|
|
Overall Study
NOT COMPLETED
|
605
|
Reasons for withdrawal
| Measure |
Natalizumab
300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
|
|---|---|
|
Overall Study
Lack of Efficacy
|
7
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Adverse Event
|
63
|
|
Overall Study
Voluntary Withdrawal
|
120
|
|
Overall Study
Subject was Noncompliant
|
9
|
|
Overall Study
Death
|
9
|
|
Overall Study
Anti-natalizumab Positive
|
8
|
|
Overall Study
Switched to Commercial Tysabri
|
22
|
|
Overall Study
Disease Progression
|
8
|
|
Overall Study
Fear of PML
|
10
|
|
Overall Study
Anti-JCV Antibody Positive
|
13
|
|
Overall Study
Miscellaneous
|
5
|
|
Overall Study
Sponsor Decision
|
34
|
|
Overall Study
Subject Relocated
|
7
|
|
Overall Study
Subject Withdrew Consent
|
37
|
|
Overall Study
Persistently Positive Antibodies
|
11
|
|
Overall Study
Investigator Withdrew From Program
|
19
|
|
Overall Study
Did Not Enroll to Week 264
|
34
|
|
Overall Study
Did Not Enroll to Week 480
|
17
|
|
Overall Study
No data available after Week 264
|
161
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Natalizumab (Tysabri) Re-Initiation of Dosing
Baseline characteristics by cohort
| Measure |
Natalizumab
n=1094 Participants
300 mg IV infusions once every 4 weeks for up to 480 weeks
|
|---|---|
|
Age, Continuous
|
41.4 years
STANDARD_DEVIATION 8.12 • n=5 Participants
|
|
Age, Customized
20 to 29 years
|
98 years
n=5 Participants
|
|
Age, Customized
30 to 39 years
|
347 years
n=5 Participants
|
|
Age, Customized
40 to 49 years
|
454 years
n=5 Participants
|
|
Age, Customized
50 to 59 years
|
195 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
755 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
339 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 480 weeksPopulation: Participants with EDSS progression (regardless of length of follow-up) sustained for 24 weeks.
Time to 24-week confirmed EDSS progression in participants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and \< 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 24 weeks.
Outcome measures
| Measure |
Natalizumab
n=220 Participants
300 mg IV infusions once every 4 weeks for up to 480 weeks
|
|---|---|
|
Time to 24-week Confirmed Expanded Disability Status Scale (EDSS) Progression
|
121.9 weeks
Interval 67.9 to 216.1
|
PRIMARY outcome
Timeframe: up to 480 weeksPopulation: Participants with EDSS progression (regardless of length of follow-up) sustained for 48 weeks.
Time to 48-week confirmed EDSS progression in particpants with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 48-week EDSS progression was defined as ≥ 0.5 point increase from a baseline EDSS ≥ 6.0, or ≥ 1.0 point increase from a baseline EDSS ≥ 1.0 and \< 6.0, or ≥ 1.5 point increase from a baseline EDSS of 0, all sustained for 48 weeks.
Outcome measures
| Measure |
Natalizumab
n=181 Participants
300 mg IV infusions once every 4 weeks for up to 480 weeks
|
|---|---|
|
Time to 48-week Confirmed EDSS Progression
|
130.1 weeks
Interval 72.4 to 216.1
|
PRIMARY outcome
Timeframe: Up to 480 weeksPopulation: Participants with EDSS improvement (regardless of length of follow-up) sustained for 24 weeks.
Time to 24-week confirmed EDSS improvement in subjects with at least 2 post-baseline milestone EDSS assessments. EDSS assesses disability in 8 functional systems. An overall score ranging from 0 (normal) to 10 (death due to MS) was reported. Confirmed 24-week EDSS improvement is defined as ≥ 1.0 point decrease from baseline sustained for 24 weeks.
Outcome measures
| Measure |
Natalizumab
n=173 Participants
300 mg IV infusions once every 4 weeks for up to 480 weeks
|
|---|---|
|
Time to 24-week Confirmed EDSS Improvement Where Baseline ≥ 2.0
|
48.1 weeks
Interval 24.1 to 119.9
|
Adverse Events
Natalizumab
Serious events: 231 serious events
Other events: 752 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Natalizumab
n=1094 participants at risk
300 mg IV infusions once every 4 weeks for up to 480 weeks
|
|---|---|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
1.6%
18/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Urinary tract infection
|
1.2%
13/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Pneumonia
|
0.37%
4/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Gastroenteritis
|
0.27%
3/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Bronchitis viral
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Cystitis
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Influenza
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Staphylococcal infection
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Appendicitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Atypical pneumonia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Bronchitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Bronchopneumonia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Catheter site infection
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Cellulitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Device related sepsis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Diverticulitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Epididymitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Gastroenteritis viral
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Hepatitis A
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Herpes zoster
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Lung infection
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Meningitis viral
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Nasopharyngitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Oral candidiasis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Pelvic inflammatory disease
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Peritonitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Pharyngitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Pneumonia streptococcal
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Pyelonephritis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Sinusitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Tooth abscess
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Wound infection
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.46%
5/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.46%
5/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.46%
5/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intraductal proliferative breast lesion
|
0.27%
3/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of salivary gland
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bile duct adenocarcinoma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cerebellopontine angle tumour
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lobular breast carcinoma in situ
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic malignant melanoma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Teratoma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Blood and lymphatic system disorders
Coombs negative haemolytic anaemia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Blood and lymphatic system disorders
Immune thrombocytopenic purpura
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Blood and lymphatic system disorders
Splenomegaly
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Immune system disorders
Immune reconstitution inflammatory syndrome
|
1.0%
11/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Immune system disorders
Anaphylactic shock
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Immune system disorders
Hypersensitivity
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Immune system disorders
Anaphylactic reaction
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Immune system disorders
Drug hypersensitivity
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Endocrine disorders
Goitre
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Endocrine disorders
Hyperthyroidism
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Depression
|
0.37%
4/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Suicide attempt
|
0.27%
3/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Completed suicide
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Mania
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Suicidal ideation
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Abnormal behaviour
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Anxiety disorder
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Bipolar I disorder
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Confusional state
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Obsessive-compulsive disorder
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Psychotic disorder
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Schizophrenia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
1.9%
21/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Multiple sclerosis
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Trigeminal neuralgia
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Altered state of consciousness
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Amnesia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Cerebral cyst
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Convulsion
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Encephalopathy
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Epilepsy
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Facial neuralgia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Headache
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Hypoxic-ischaemic encephalopathy
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Migraine
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Sciatica
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Eye disorders
Eye swelling
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Eye disorders
Glaucoma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Eye disorders
Retinal tear
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Eye disorders
Vision blurred
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Cardiac disorders
Atrial fibrillation
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Cardiac disorders
Myocardial infarction
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Cardiac disorders
Angina pectoris
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Cardiac disorders
Myocardial fibrosis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Cardiac disorders
Sinus tachycardia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Vascular disorders
Deep vein thrombosis
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Vascular disorders
Peripheral ischaemia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Vascular disorders
Thrombophlebitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Vascular disorders
Venous stenosis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.27%
3/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Abdominal adhesions
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Anal fissure
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Constipation
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Abdominal hernia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Duodenitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Faecaloma
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Flatulence
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Functional gastrointestinal disorder
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Ileus
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Proctalgia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Rectal prolapse
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.46%
5/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Skin and subcutaneous tissue disorders
Melanocytic hyperplasia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.46%
5/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.27%
3/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Joint instability
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal disorder
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Spinal osteoarthritis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Renal and urinary disorders
Renal colic
|
0.27%
3/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Renal and urinary disorders
Haematuria
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Renal and urinary disorders
Neurogenic bladder
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Renal and urinary disorders
Renal failure acute
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Renal and urinary disorders
Urinary retention
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion missed
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Pregnancy, puerperium and perinatal conditions
Foetal death
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Pregnancy, puerperium and perinatal conditions
Haemorrhage in pregnancy
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Pregnancy, puerperium and perinatal conditions
Premature baby
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Uterine polyp
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Adnexal torsion
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Breast hyperplasia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Breast mass
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Menometrorrhagia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Rectocele
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Congenital, familial and genetic disorders
Congenital anomaly
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
General disorders
Pyrexia
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
General disorders
Chest pain
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
General disorders
Fatigue
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
General disorders
Multi-organ failure
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
General disorders
Oedema
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
General disorders
Pain
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
General disorders
Polyp
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Investigations
Blood pressure increased
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Investigations
Polyomavirus test positive
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Fall
|
0.64%
7/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.37%
4/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.27%
3/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.18%
2/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Accidental overdose
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Arteriovenous fistula site complication
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Gun shot wound
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Traumatic intracranial haemorrhage
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Surgical and medical procedures
Peripheral nerve decompression
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Surgical and medical procedures
Spinal laminectomy
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Surgical and medical procedures
Thyroid nodule removal
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Surgical and medical procedures
Vascular graft
|
0.09%
1/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
Other adverse events
| Measure |
Natalizumab
n=1094 participants at risk
300 mg IV infusions once every 4 weeks for up to 480 weeks
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
7.3%
80/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
General disorders
Fatigue
|
9.3%
102/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Nasopharyngitis
|
23.4%
256/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.6%
192/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Urinary tract infection
|
14.8%
162/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Influenza
|
11.2%
122/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Sinusitis
|
7.5%
82/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Infections and infestations
Bronchitis
|
6.1%
67/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Injury, poisoning and procedural complications
Fall
|
5.6%
61/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.3%
113/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.9%
86/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.7%
62/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Multiple sclerosis relapse
|
15.0%
164/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Headache
|
14.4%
157/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Nervous system disorders
Dizziness
|
5.7%
62/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
|
Psychiatric disorders
Depression
|
6.6%
72/1094 • Serious adverse events (SAEs) were collected from screening through the follow-up (492 weeks). Non-serious AEs were collected from baseline through Week 264.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER